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NCT04505553 · OUTCOME

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

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
3 months

What was measured

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.

Analysis population: Frequency of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

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

GroupSource count
Arm I (Acupuncture, Acupressure, Cryotherapy)33
Arm II (Cryotherapy)36

Reported measurements

Source class 1

No Peripheral Sensory Neuropathy

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Acupuncture, Acupressure, Cryotherapy)28Not reportedNot reportedNot reportedNot reported
Arm II (Cryotherapy)33Not reportedNot reportedNot reportedNot reported

Peripheral Sensory Neuropathy

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Acupuncture, Acupressure, Cryotherapy)5Not reportedNot reportedNot reportedNot reported
Arm II (Cryotherapy)3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        33
      title
      No Peripheral Sensory Neuropathy
    2. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      title
      Peripheral Sensory Neuropathy
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      36
    units
    Participants
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.
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. 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)
  2. 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
COUNT_OF_PARTICIPANTS
population Description
Frequency of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
reporting Status
POSTED
time Frame
3 months
title
Number of Participants With Grade 2 or Higher Chemotherapy-Induced Peripheral Neuropathy
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice