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NCT00503776 · OUTCOME

Changes in the Amount and Texture of Food Consumed

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
at baseline, at 1 month, 3 months and 6 months post-chemoradiation

What was measured

Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.

Analysis population: Due to loss of funding, sufficient data for analysis was not collected.

Groups in this outcome

Arm IA

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

Arm IB

Patients undergo SNT and low weight resistance training (LWRT). exercise intervention: Patients undergo low weight resistance training. therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

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. amifostine trihydrate: Given subcutaneously therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

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. exercise intervention: Patients undergo low weight resistance training. amifostine trihydrate: Given subcutaneously therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

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 IA0
Arm IB0
Arm IIA0
Arm IIB0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    units
    Participants
description
Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.
groups
  1. description
    Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. therapeutic dietary intervention: 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). exercise intervention: Patients undergo low weight resistance training. therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
    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. amifostine trihydrate: Given subcutaneously therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
    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. exercise intervention: Patients undergo low weight resistance training. amifostine trihydrate: Given subcutaneously therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
    id
    OG003
    title
    Arm IIB
population Description
Due to loss of funding, sufficient data for analysis was not collected.
reporting Status
POSTED
time Frame
at baseline, at 1 month, 3 months and 6 months post-chemoradiation
title
Changes in the Amount and Texture of Food Consumed
type
SECONDARY

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

Preserved source evidence · Not medical advice