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NCT01066624 · OUTCOME

Incidence of Oral Mucositis

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.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
First 30 days post-tranplantation

What was measured

Incidence of grade I-IV oral mucositis

Groups in this outcome

0.9% Sodium Chloride Irrigation Solution

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

Cryotherapy (Ice Chips)

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.

Calcium Phosphate (Caphosol) 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. 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
0.9% Sodium Chloride Irrigation Solution38
Cryotherapy (Ice Chips)40
Calcium Phosphate (Caphosol) Mouth Rinse39

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.9% Sodium Chloride Irrigation Solution66Not reportedNot reportedNot reportedNot reported
Cryotherapy (Ice Chips)10Not reportedNot reportedNot reportedNot reported
Calcium Phosphate (Caphosol) Mouth Rinse64Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        64
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      40
    3. group Id
      OG002
      value
      39
    units
    Participants
description
Incidence of grade I-IV oral mucositis
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
    OG000
    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
    OG001
    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
    OG002
    title
    Calcium Phosphate (Caphosol) Mouth Rinse
param Type
NUMBER
reporting Status
POSTED
time Frame
First 30 days post-tranplantation
title
Incidence of Oral Mucositis
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice