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NCT01066624 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    title
    Calcium Phosphate (Caphosol) Mouth Rinse
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        39
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    title
    Calcium Phosphate (Caphosol) Mouth Rinse
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        39
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice