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NCT04505553 · OUTCOME

Severity of CIPN: Tuning Fork Vibration Sensation Testing

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
seconds
Interval / dispersion
Standard Deviation
Time frame
3 months

What was measured

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.

Analysis population: Due to missing acupuncture appointments 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

GroupSource count
Arm I (Acupuncture, Acupressure, Cryotherapy)21
Arm II (Cryotherapy)27

Reported measurements

Source class 1
Values in seconds · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm I (Acupuncture, Acupressure, Cryotherapy)-5.011.6Not reportedNot reportedNot reported
Arm II (Cryotherapy)0.16.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.6
        value
        -5.0
      2. group Id
        OG001
        spread
        6.6
        value
        0.1
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      27
    units
    Participants
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.
dispersion Type
Standard Deviation
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
MEAN
population Description
Due to missing acupuncture appointments the overall number of participants analyzed differs from patients that completed the study.
reporting Status
POSTED
time Frame
3 months
title
Severity of CIPN: Tuning Fork Vibration Sensation Testing
type
SECONDARY
unit Of Measure
seconds

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

Preserved source evidence · Not medical advice