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NCT00503776 · OUTCOME

Number of Patients With Oral Mucositis by Grade

Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia · Source last updated 2017-06-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
6 months after concurrent chemotherapy and radiation

What was measured

Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).

Analysis population: Participants available for 6-month follow-up oral examination. No 6-month follow-up data were available for the following numbers of patients: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2).

Groups in this outcome

Arm IA

Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Arm IB

Patients undergo SNT and low weight resistance training (LWRT).

Arm IIA

Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.

Arm IIB

Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

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 IA7
Arm IB8
Arm IIA9
Arm IIB8

Reported measurements

No. of patients with grade 0, no mucositis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm IA3Not reportedNot reportedNot reportedNot reported
Arm IB4Not reportedNot reportedNot reportedNot reported
Arm IIA6Not reportedNot reportedNot reportedNot reported
Arm IIB3Not reportedNot reportedNot reportedNot reported
No. of patients with grade 1, mild mucositis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm IA0Not reportedNot reportedNot reportedNot reported
Arm IB4Not reportedNot reportedNot reportedNot reported
Arm IIA2Not reportedNot reportedNot reportedNot reported
Arm IIB3Not reportedNot reportedNot reportedNot reported
No of patients with grade 2, moderate mucositis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm IA1Not reportedNot reportedNot reportedNot reported
Arm IB0Not reportedNot reportedNot reportedNot reported
Arm IIA1Not reportedNot reportedNot reportedNot reported
Arm IIB2Not reportedNot reportedNot reportedNot reported
No of patients with grade 3, severe mucositis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm IA3Not reportedNot reportedNot reportedNot reported
Arm IB0Not reportedNot reportedNot reportedNot reported
Arm IIA0Not reportedNot reportedNot reportedNot reported
Arm IIB0Not reportedNot reportedNot reportedNot reported
No. of patients with grade 4, disabling mucositis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm IA0Not reportedNot reportedNot reportedNot reported
Arm IB0Not reportedNot reportedNot reportedNot reported
Arm IIA0Not reportedNot reportedNot reportedNot reported
Arm IIB0Not reportedNot reportedNot reportedNot reported
No. of patients with grade 5 mucositis, death
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm IA0Not reportedNot reportedNot reportedNot reported
Arm IB0Not reportedNot reportedNot reportedNot reported
Arm IIA0Not reportedNot reportedNot reportedNot reported
Arm IIB0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        3
    title
    No. of patients with grade 0, no mucositis
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
    title
    No. of patients with grade 1, mild mucositis
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
    title
    No of patients with grade 2, moderate mucositis
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    No of patients with grade 3, severe mucositis
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    No. of patients with grade 4, disabling mucositis
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    No. of patients with grade 5 mucositis, death
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      8
    units
    Participants
description
Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).
groups
  1. description
    Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
    id
    OG000
    title
    Arm IA
  2. description
    Patients undergo SNT and low weight resistance training (LWRT).
    id
    OG001
    title
    Arm IB
  3. description
    Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
    id
    OG002
    title
    Arm IIA
  4. description
    Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
    id
    OG003
    title
    Arm IIB
param Type
NUMBER
population Description
Participants available for 6-month follow-up oral examination. No 6-month follow-up data were available for the following numbers of patients: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2).
reporting Status
POSTED
time Frame
6 months after concurrent chemotherapy and radiation
title
Number of Patients With Oral Mucositis by Grade
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice