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NCT04505553 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      33
    2. group Id
      BG001
      value
      36
    3. group Id
      BG002
      value
      69
    units
    Participants
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
    BG000
    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
    BG001
    title
    Arm II (Cryotherapy)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          68
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          34
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          60
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          50
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          69
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.7
          value
          35
        2. group Id
          BG001
          spread
          4.5
          value
          36.4
        3. group Id
          BG002
          spread
          4.2
          value
          35.8
      title
      Sensory
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.9
          value
          36.5
        2. group Id
          BG001
          spread
          6.6
          value
          36.8
        3. group Id
          BG002
          spread
          6.2
          value
          36.6
      title
      Motor
    3. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.6
          value
          37.8
        2. group Id
          BG001
          spread
          16.7
          value
          45.3
        3. group Id
          BG002
          spread
          15.1
          value
          42.1
      title
      Autonomic
    description
    EORTC (European Organisation For Research And Treatment Of Cancer) CIPN (Chemotherapy-Induced Peripheral Neuropathy) 20 QOL (Quality of Life Questionnaire) patient reported outcomes questionnaire was used. 3 subscales all scored from 1 to 4: Sensory, Motor, and Autonomic. For all subscales: higher values represent a worse outcome. All subscales are to be reported separately. The raw scores are linearly converted to a 0-100 scale such that a higher score corresponds to a worse condition or more symptoms.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    European Organisation For Research & Treatment of Cancer-CIPN 20 questionnaire
    unit Of Measure
    units on a scale
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      33
    2. group Id
      BG001
      value
      36
    3. group Id
      BG002
      value
      69
    units
    Participants
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
    BG000
    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
    BG001
    title
    Arm II (Cryotherapy)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          68
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          34
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          60
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          50
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          69
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.7
          value
          35
        2. group Id
          BG001
          spread
          4.5
          value
          36.4
        3. group Id
          BG002
          spread
          4.2
          value
          35.8
      title
      Sensory
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.9
          value
          36.5
        2. group Id
          BG001
          spread
          6.6
          value
          36.8
        3. group Id
          BG002
          spread
          6.2
          value
          36.6
      title
      Motor
    3. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.6
          value
          37.8
        2. group Id
          BG001
          spread
          16.7
          value
          45.3
        3. group Id
          BG002
          spread
          15.1
          value
          42.1
      title
      Autonomic
    description
    EORTC (European Organisation For Research And Treatment Of Cancer) CIPN (Chemotherapy-Induced Peripheral Neuropathy) 20 QOL (Quality of Life Questionnaire) patient reported outcomes questionnaire was used. 3 subscales all scored from 1 to 4: Sensory, Motor, and Autonomic. For all subscales: higher values represent a worse outcome. All subscales are to be reported separately. The raw scores are linearly converted to a 0-100 scale such that a higher score corresponds to a worse condition or more symptoms.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    European Organisation For Research & Treatment of Cancer-CIPN 20 questionnaire
    unit Of Measure
    units on a scale

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

Preserved source evidence · Not medical advice