NCT04505553 · OUTCOME
Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months
Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer · Source last updated 2026-01-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- 3 months
What was measured
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.
Analysis population: Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.
Groups in this outcome
Arm I (Acupuncture, Acupressure, Cryotherapy)
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
Arm II (Cryotherapy)
Patients undergo standard of care oral cryotherapy.
Oral Cryotherapy: Undergo oral cryotherapy
Questionnaire Administration: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | 20 |
|---|
| Arm II (Cryotherapy) | 27 |
|---|
Reported measurements
Pain
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | 19 |
|---|
| Arm II (Cryotherapy) | 27 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | -0.3 | 1.2 | Not reported | Not reported | Not reported |
|---|
| Arm II (Cryotherapy) | -0.3 | 1.1 | Not reported | Not reported | Not reported |
|---|
Fatigue
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | 20 |
|---|
| Arm II (Cryotherapy) | 27 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | -0.1 | 0.9 | Not reported | Not reported | Not reported |
|---|
| Arm II (Cryotherapy) | 0.4 | 1.2 | Not reported | Not reported | Not reported |
|---|
Nausea
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | 19 |
|---|
| Arm II (Cryotherapy) | 27 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | -0.3 | 0.7 | Not reported | Not reported | Not reported |
|---|
| Arm II (Cryotherapy) | 0.3 | 1.0 | Not reported | Not reported | Not reported |
|---|
Anxiety
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | 19 |
|---|
| Arm II (Cryotherapy) | 27 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | -0.1 | 1.0 | Not reported | Not reported | Not reported |
|---|
| Arm II (Cryotherapy) | -0.1 | 0.9 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.2
- value
- -0.3
- group Id
- OG001
- spread
- 1.1
- value
- -0.3
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Pain
- categories
- measurements
- group Id
- OG000
- spread
- 0.9
- value
- -0.1
- group Id
- OG001
- spread
- 1.2
- value
- 0.4
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Fatigue
- categories
- measurements
- group Id
- OG000
- spread
- 0.7
- value
- -0.3
- group Id
- OG001
- spread
- 1.0
- value
- 0.3
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Nausea
- categories
- measurements
- group Id
- OG000
- spread
- 1.0
- value
- -0.1
- group Id
- OG001
- spread
- 0.9
- value
- -0.1
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Anxiety
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 27
- units
- Participants
- description
- 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.
- dispersion Type
- Standard Deviation
- groups
- description
- 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
- id
- OG000
- title
- Arm I (Acupuncture, Acupressure, Cryotherapy)
- description
- Patients undergo standard of care oral cryotherapy.
Oral Cryotherapy: Undergo oral cryotherapy
Questionnaire Administration: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
- id
- OG001
- title
- Arm II (Cryotherapy)
- param Type
- MEAN
- population Description
- Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.
- reporting Status
- POSTED
- time Frame
- 3 months
- title
- Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle