Skip to content
Triangle logo TriangleGet started
← Malignant Appendix Neoplasm

NCT04505553 · STUDY IN CONTEXT

Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms. Change in severity was measured by the difference in the converted scores from baseline to three months and the range is -100 to 100.

Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.

→

secondary · POSTED

Measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5. Incidences of CIPN (grade 2 or higher), pain, fatigue, nausea, and anxiety will be compared between treatment arms using Chi-squared or Fisher's exact tests as appropriate.

Frequency of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

→

secondary · POSTED

The Neuropen is used to assess pressure perception. Pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot at each of the ten different sites recorded as present or absent. The proportion present was calculated for each patient at baseline and at 3 months. The difference between these proportions from baseline to 3 months was calculated for each patient. The mean of these differences was calculated within each arm and the difference of those means was then compared between arms.

Due to missing acupuncture appointments the overall number of participants analyzed differs from patients that completed the study.

→

secondary · POSTED

A study-specific 128-Hz tuning fork will be used to assess vibration sensation on the great toe at baseline and 3 months. The time in seconds to loss of vibration sensation was measured. Vibration sensation is lost sooner in CIPN, which means that shorter duration of vibration scores are associated with increased CIPN. The difference from baseline to 3 months in number of seconds to loss of vibration sensation was calculated for each patient. The differences were averaged across patients in each arm. The mean differences were compared between arms.

Due to missing acupuncture appointments the overall number of participants analyzed differs from patients that completed the study.

→

secondary · POSTED

Adherence to acupuncture treatment among patients in the intervention arm will be described as a proportion with 95% confidence interval. Reasons for treatment non-adherence and delivered dose intensity of chemotherapy will be noted.

Summary of Patient Adherence to Acupuncture Protocol Based on 60% Threshold

→

secondary · POSTED

Measured by patient-reported National Cancer Institute \[NCI\] Patient Reported Outcomes \[PRO\]-CTCAE. The change in severity from baseline to 3 months was calculated and it ranged from -3 to 3. The severity was measured on a 0-3 (0=None, 3=Severe) scale with a higher value representing a worse outcome and a lower value representing a better outcome. This was done separately for pain, fatigue, nausea, and anxiety.

Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-appendix-neoplasm
nct id
NCT04505553
qol key
qol-0000
source section id
NCT04505553-om-0000
source outcome index
0
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months
measure definition
Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms. Change in severity was measured by the difference in the converted scores from baseline to three months and the range is -100 to 100.
time frame
At 3 months
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Patient-reported symptom or function measure · Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-appendix-neoplasm
nct id
NCT04505553
qol key
qol-0005
source section id
NCT04505553-om-0005
source outcome index
5
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient-reported' in the study's own wording
scale title
Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months
measure definition
Measured by patient-reported National Cancer Institute \[NCI\] Patient Reported Outcomes \[PRO\]-CTCAE. The change in severity from baseline to 3 months was calculated and it ranged from -3 to 3. The severity was measured on a 0-3 (0=None, 3=Severe) scale with a higher value representing a worse outcome and a lower value representing a better outcome. This was done separately for pain, fatigue, nausea, and anxiety.
time frame
3 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-malignant-appendix-neoplasm
nct id
NCT04505553
trial label
Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0000
    source section id
    NCT04505553-om-0000
    source outcome index
    0
    endpoint
    Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months
    endpoint definition
    Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms. Change in severity was measured by the difference in the converted scores from baseline to three months and the range is -100 to 100.
    time origin
    At 3 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0001
    source section id
    NCT04505553-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Grade 2 or Higher Chemotherapy-Induced Peripheral Neuropathy
    endpoint definition
    Measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5. Incidences of CIPN (grade 2 or higher), pain, fatigue, nausea, and anxiety will be compared between treatment arms using Chi-squared or Fisher's exact tests as appropriate.
    time origin
    3 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Frequency of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0002
    source section id
    NCT04505553-om-0002
    source outcome index
    2
    endpoint
    Severity of CIPN: Neuropen Assessment of Patients' Perceived Pressure
    endpoint definition
    The Neuropen is used to assess pressure perception. Pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot at each of the ten different sites recorded as present or absent. The proportion present was calculated for each patient at baseline and at 3 months. The difference between these proportions from baseline to 3 months was calculated for each patient. The mean of these differences was calculated within each arm and the difference of those means was then compared between arms.
    time origin
    3 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Due to missing acupuncture appointments the overall number of participants analyzed differs from patients that completed the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0003
    source section id
    NCT04505553-om-0003
    source outcome index
    3
    endpoint
    Severity of CIPN: Tuning Fork Vibration Sensation Testing
    endpoint definition
    A study-specific 128-Hz tuning fork will be used to assess vibration sensation on the great toe at baseline and 3 months. The time in seconds to loss of vibration sensation was measured. Vibration sensation is lost sooner in CIPN, which means that shorter duration of vibration scores are associated with increased CIPN. The difference from baseline to 3 months in number of seconds to loss of vibration sensation was calculated for each patient. The differences were averaged across patients in each arm. The mean differences were compared between arms.
    time origin
    3 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Due to missing acupuncture appointments the overall number of participants analyzed differs from patients that completed the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0004
    source section id
    NCT04505553-om-0004
    source outcome index
    4
    endpoint
    Proportion of Patients Assigned to the Intervention Arm Who Complete 60% of Acupuncture Treatments
    endpoint definition
    Adherence to acupuncture treatment among patients in the intervention arm will be described as a proportion with 95% confidence interval. Reasons for treatment non-adherence and delivered dose intensity of chemotherapy will be noted.
    time origin
    3 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Summary of Patient Adherence to Acupuncture Protocol Based on 60% Threshold
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0005
    source section id
    NCT04505553-om-0005
    source outcome index
    5
    endpoint
    Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months
    endpoint definition
    Measured by patient-reported National Cancer Institute \[NCI\] Patient Reported Outcomes \[PRO\]-CTCAE. The change in severity from baseline to 3 months was calculated and it ranged from -3 to 3. The severity was measured on a 0-3 (0=None, 3=Severe) scale with a higher value representing a worse outcome and a lower value representing a better outcome. This was done separately for pain, fatigue, nausea, and anxiety.
    time origin
    3 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I (Acupuncture, Acupressure, Cryotherapy)
    regimen
    Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04505553-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II (Cryotherapy)
    regimen
    Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04505553-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I (Acupuncture, Acupressure, Cryotherapy)
    regimen
    Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
    analyzed count
    33
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04505553-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II (Cryotherapy)
    regimen
    Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04505553-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I (Acupuncture, Acupressure, Cryotherapy)
    regimen
    Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04505553-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm II (Cryotherapy)
    regimen
    Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04505553-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm I (Acupuncture, Acupressure, Cryotherapy)
    regimen
    Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04505553-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm II (Cryotherapy)
    regimen
    Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04505553-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm I (Acupuncture, Acupressure, Cryotherapy)
    regimen
    Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
    analyzed count
    33
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04505553-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Arm I (Acupuncture, Acupressure, Cryotherapy)
    regimen
    Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04505553-om-0005#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Arm II (Cryotherapy)
    regimen
    Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04505553-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    harm key
    EG000
    source section id
    NCT04505553-ae
    event group key
    EG000
    event group label
    Arm I (Acupuncture, Acupressure, Cryotherapy)
    serious affected
    0
    serious at risk
    33
    other affected
    18
    other at risk
    33
    frequency threshold
    0
    collection period
    22 weeks
    event definition
    CTCAE vr. 5 terms used
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    harm key
    EG001
    source section id
    NCT04505553-ae
    event group key
    EG001
    event group label
    Arm II (Cryotherapy)
    serious affected
    0
    serious at risk
    36
    other affected
    26
    other at risk
    36
    frequency threshold
    0
    collection period
    22 weeks
    event definition
    CTCAE vr. 5 terms used
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    qol key
    qol-0000
    source section id
    NCT04505553-om-0000
    source outcome index
    0
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months
    measure definition
    Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms. Change in severity was measured by the difference in the converted scores from baseline to three months and the range is -100 to 100.
    time frame
    At 3 months
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-appendix-neoplasm
    nct id
    NCT04505553
    qol key
    qol-0005
    source section id
    NCT04505553-om-0005
    source outcome index
    5
    instrument
    Patient-reported symptom or function measure
    instrument basis
    matched 'patient-reported' in the study's own wording
    scale title
    Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months
    measure definition
    Measured by patient-reported National Cancer Institute \[NCI\] Patient Reported Outcomes \[PRO\]-CTCAE. The change in severity from baseline to 3 months was calculated and it ranged from -3 to 3. The severity was measured on a 0-3 (0=None, 3=Severe) scale with a higher value representing a worse outcome and a lower value representing a better outcome. This was done separately for pain, fatigue, nausea, and anxiety.
    time frame
    3 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice