Participant flow

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.

groups

1. description

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

   id

   FG000

   title

   Arm IA

2. description

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

   id

   FG001

   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

   FG002

   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

   FG003

   title

   Arm IIB

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         12

      3. comment

         one patient withdrew before receiving protocol therapy

         group Id

         FG002

         num Subjects

         12

      4. comment

         one patient withdrew before receiving protocol therapy

         group Id

         FG003

         num Subjects

         10

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         12

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         8

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

43 patients consented, one was ineligible for a total of 42 patients on study.

recruitment Details

This study was open to accrual from 01/01/2006 through 03/05/2008.

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

Preserved source evidence · Not medical advice