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NCT04505553 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2026-01-21

This phase II trial investigates how well oral cryotherapy plus acupressure and acupuncture compared with oral cryotherapy alone work in decreasing chemotherapy-induced peripheral neuropathy in patients with gastrointestinal cancer who are receiving oxaliplatin-based chemotherapy. Acupressure is the application of pressure or localized massage to specific sites on the body to control symptoms such as pain or nausea. Acupuncture is the technique of inserting thin needles through the skin at specific points on the body to control pain and other symptoms. Cryotherapy uses cold temperature such as oral ice chips to prevent abnormally increased pain sensation. Giving oral cryotherapy with acupressure and acupuncture may work better in decreasing chemotherapy-induced peripheral neuropathy from oxaliplatin-based chemotherapy in patients with gastrointestinal cancer compared to oral cryotherapy alone.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Number of Participants With Grade 2 or Higher Chemotherapy-Induced Peripheral Neuropathy

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outcome · POSTED

Severity of CIPN: Neuropen Assessment of Patients' Perceived Pressure

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outcome · POSTED

Severity of CIPN: Tuning Fork Vibration Sensation Testing

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outcome · POSTED

Proportion of Patients Assigned to the Intervention Arm Who Complete 60% of Acupuncture Treatments

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outcome · POSTED

Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * GI cancer (primary esophagus, gastric, pancreas, biliary, liver, small bowel, appendix, colon, rectal, anal, or gastrointestinal/pancreatic neuroendocrine tumor) scheduled to receive a new start of fluorouracil (5-FU), oxaliplatin, +/- irinotecan (fluorouracil/leucovorin calcium/oxaliplatin \[FOLFOX\], fluorouracil/irinotecan/leucovorin calcium/oxaliplatin \[FOLFIRINOX\], leucovorin/fluorouracil/oxaliplatin/irinotecan \[FOLFOXIRI\] regimens) with plan for \>= 3 months of therapy with the regimen. Chemotherapy can be given for neoadjuvant, adjuvant, or palliative intent. 1 dose (cycle) of the intended regimen is permitted prior to study enrollment. \*\*There is no limitation on the addition of a biologic agent to one of the above chemotherapy regimens, including, but not limited to: bevacizumab, cetuximab, panitumumab, trastuzumab, or the biosimilars of these agents * Age \>=18 years * Absolute neutrophil count \> 0.5 thousand/microL * Platelet count \> 20 thousand/microL * Not currently pregnant * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Baseline peripheral neuropathy from any cause * Planned oxaliplatin with capecitabine * Planned initial dose of oxaliplatin \< 100% of the standard regimen-specified dose. For most regimens, this would be 85 mg/m\^2 intravenously (IV) dosed every 14 days * Receipt of acupuncture treatment in the prior 3 months * Use of concomitant duloxetine for minimization of neuropathy * Psychiatric illness/social situations that would limit compliance with study requirements
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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.
    intervention Names
    1. Procedure: Acupuncture Therapy
    2. Procedure: Acupressure Therapy
    3. Procedure: Oral Cryotherapy
    4. Other: Questionnaire Administration
    5. Other: Quality-of-Life Assessment
    label
    Arm I (acupuncture, acupressure, cryotherapy)
    type
    EXPERIMENTAL
  2. description
    Patients undergo standard of care oral cryotherapy.
    intervention Names
    1. Procedure: Oral Cryotherapy
    2. Other: Questionnaire Administration
    3. Other: Quality-of-Life Assessment
    label
    Arm II (cryotherapy)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I (acupuncture, acupressure, cryotherapy)
    description
    Undergo acupuncture
    name
    Acupuncture Therapy
    other Names
    1. Acupuncture
    type
    PROCEDURE
  2. arm Group Labels
    1. Arm I (acupuncture, acupressure, cryotherapy)
    description
    Undergo acupressure
    name
    Acupressure Therapy
    other Names
    1. acupressure
    2. Ischemic Compression
    type
    PROCEDURE
  3. arm Group Labels
    1. Arm I (acupuncture, acupressure, cryotherapy)
    2. Arm II (cryotherapy)
    description
    Undergo oral cryotherapy
    name
    Oral Cryotherapy
    type
    PROCEDURE
  4. arm Group Labels
    1. Arm I (acupuncture, acupressure, cryotherapy)
    2. Arm II (cryotherapy)
    description
    Ancillary studies
    name
    Questionnaire Administration
    type
    OTHER
  5. arm Group Labels
    1. Arm I (acupuncture, acupressure, cryotherapy)
    2. Arm II (cryotherapy)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
78
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months
    time Frame
    At 3 months
secondary Outcomes
  1. description
    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.
    measure
    Number of Participants With Grade 2 or Higher Chemotherapy-Induced Peripheral Neuropathy
    time Frame
    3 months
  2. description
    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.
    measure
    Severity of CIPN: Neuropen Assessment of Patients' Perceived Pressure
    time Frame
    3 months
  3. description
    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.
    measure
    Severity of CIPN: Tuning Fork Vibration Sensation Testing
    time Frame
    3 months
  4. description
    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.
    measure
    Proportion of Patients Assigned to the Intervention Arm Who Complete 60% of Acupuncture Treatments
    time Frame
    3 months
  5. 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.
    measure
    Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months
    time Frame
    3 months
Full study description
brief Summary
This phase II trial investigates how well oral cryotherapy plus acupressure and acupuncture compared with oral cryotherapy alone work in decreasing chemotherapy-induced peripheral neuropathy in patients with gastrointestinal cancer who are receiving oxaliplatin-based chemotherapy. Acupressure is the application of pressure or localized massage to specific sites on the body to control symptoms such as pain or nausea. Acupuncture is the technique of inserting thin needles through the skin at specific points on the body to control pain and other symptoms. Cryotherapy uses cold temperature such as oral ice chips to prevent abnormally increased pain sensation. Giving oral cryotherapy with acupressure and acupuncture may work better in decreasing chemotherapy-induced peripheral neuropathy from oxaliplatin-based chemotherapy in patients with gastrointestinal cancer compared to oral cryotherapy alone.
detailed Description
OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: 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. ARM II: Patients undergo standard of care oral cryotherapy.
Source references
Source notices and limitations
    Discovery and provenance
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice