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NCT00503776 · OUTCOME

Stimulated and Unstimulated Salivary Production

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
MEAN
Unit
mL per minute
Interval / dispersion
Standard Deviation
Time frame
6 months after concurrent chemotherapy and radiation

What was measured

Unstimulated and stimulated salivary production, measured in mL/minute. Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods. Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.

Analysis population: Patients who underwent salivary testing at 6 months. The following patients were not available at 6- months for testing for salivary production: 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

Unstimulated
Values in mL per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm IA0.640.37Not reportedNot reportedNot reported
Arm IB1.701.44Not reportedNot reportedNot reported
Arm IIA1.381.90Not reportedNot reportedNot reported
Arm IIB0.680.32Not reportedNot reportedNot reported
Stimulated
Values in mL per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm IA0.721.85Not reportedNot reportedNot reported
Arm IB5.043.16Not reportedNot reportedNot reported
Arm IIA5.253.39Not reportedNot reportedNot reported
Arm IIB0.942.25Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.37
        value
        0.64
      2. group Id
        OG001
        spread
        1.44
        value
        1.70
      3. group Id
        OG002
        spread
        1.90
        value
        1.38
      4. group Id
        OG003
        spread
        0.32
        value
        0.68
    title
    Unstimulated
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.85
        value
        0.72
      2. group Id
        OG001
        spread
        3.16
        value
        5.04
      3. group Id
        OG002
        spread
        3.39
        value
        5.25
      4. group Id
        OG003
        spread
        2.25
        value
        0.94
    title
    Stimulated
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
Unstimulated and stimulated salivary production, measured in mL/minute. Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods. Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.
dispersion Type
Standard Deviation
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
MEAN
population Description
Patients who underwent salivary testing at 6 months. The following patients were not available at 6- months for testing for salivary production: 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
Stimulated and Unstimulated Salivary Production
type
SECONDARY
unit Of Measure
mL per minute

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

Preserved source evidence · Not medical advice