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NCT01066624 · BASELINE

Baseline characteristics

Comparative Trial of Cryotherapy Versus Caphosol Versus Saline Solution Mouth Washes for the Prevention of Oral Mucositis in Patients With Multiple Myeloma Undergoing Hematopoietic Stem Cell Transplantation · Source last updated 2015-07-23

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
      38
    2. group Id
      BG001
      value
      40
    3. group Id
      BG002
      value
      39
    4. group Id
      BG003
      value
      117
    units
    Participants
groups
  1. description
    Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study. 0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study
    id
    BG000
    title
    0.9% Sodium Chloride Irrigation Solution
  2. description
    Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
    id
    BG001
    title
    Cryotherapy (Ice Chips)
  3. description
    Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study. Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.
    id
    BG002
    title
    Calcium Phosphate (Caphosol) Mouth Rinse
  4. description
    Total of all reporting groups
    id
    BG003
    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
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          88
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          29
        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
          lower Limit
          43
          upper Limit
          70
          value
          61.5
        2. group Id
          BG001
          lower Limit
          39
          upper Limit
          75
          value
          62
        3. group Id
          BG002
          lower Limit
          45
          upper Limit
          68
          value
          62
        4. group Id
          BG003
          lower Limit
          39
          upper Limit
          75
          value
          62
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          110
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          21
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          96
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          40
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          77
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          117
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      38
    2. group Id
      BG001
      value
      40
    3. group Id
      BG002
      value
      39
    4. group Id
      BG003
      value
      117
    units
    Participants
groups
  1. description
    Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study. 0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study
    id
    BG000
    title
    0.9% Sodium Chloride Irrigation Solution
  2. description
    Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
    id
    BG001
    title
    Cryotherapy (Ice Chips)
  3. description
    Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study. Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.
    id
    BG002
    title
    Calcium Phosphate (Caphosol) Mouth Rinse
  4. description
    Total of all reporting groups
    id
    BG003
    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
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          88
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          29
        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
          lower Limit
          43
          upper Limit
          70
          value
          61.5
        2. group Id
          BG001
          lower Limit
          39
          upper Limit
          75
          value
          62
        3. group Id
          BG002
          lower Limit
          45
          upper Limit
          68
          value
          62
        4. group Id
          BG003
          lower Limit
          39
          upper Limit
          75
          value
          62
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          110
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          21
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          96
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          40
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          77
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          117
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice