Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00656513 · OUTCOME

Phase II: Treatment Compliance (Number of Compliant Patients)

Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer · Source last updated 2019-11-19

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Randomization to 12 weeks

What was measured

Patients completing at least 19 out of 24 ALTENS therapy sessions were categorized as compliant. Fleming's two-stage was used, assuming a successful target compliance rate of 80%, statistical power of 0.87, and a type I error rate of 0.13. If fewer than 9 of the first 13 patients were compliant, then treatment delivery will be deemed not feasible. If there were between 9-12 compliant patients, the second stage analysis would be required to determine feasibility of treatment delivery. If all 13 patients are compliant, treatment delivery will immediately be deemed feasible. The second stage analysis required at least 31 compliant out of 39 overall patients for the treatment delivery to be deemed feasible.

Analysis population: Eligible patients starting protocol treatment

Groups in this outcome

ALTENS: Phase II

Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit

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

Analysis denominator · Participants

GroupSource count
ALTENS: Phase II47

Reported measurements

First Stage

Analysis denominator · Participants

GroupSource count
ALTENS: Phase II13
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALTENS: Phase II12Not reportedNot reportedNot reportedNot reported
Second Stage (Overall)

Analysis denominator · Participants

GroupSource count
ALTENS: Phase II47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALTENS: Phase II44Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    First Stage
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        44
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      units
      Participants
    title
    Second Stage (Overall)
denoms
  1. counts
    1. group Id
      OG000
      value
      47
    units
    Participants
description
Patients completing at least 19 out of 24 ALTENS therapy sessions were categorized as compliant. Fleming's two-stage was used, assuming a successful target compliance rate of 80%, statistical power of 0.87, and a type I error rate of 0.13. If fewer than 9 of the first 13 patients were compliant, then treatment delivery will be deemed not feasible. If there were between 9-12 compliant patients, the second stage analysis would be required to determine feasibility of treatment delivery. If all 13 patients are compliant, treatment delivery will immediately be deemed feasible. The second stage analysis required at least 31 compliant out of 39 overall patients for the treatment delivery to be deemed feasible.
groups
  1. description
    Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
    id
    OG000
    title
    ALTENS: Phase II
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible patients starting protocol treatment
reporting Status
POSTED
time Frame
Randomization to 12 weeks
title
Phase II: Treatment Compliance (Number of Compliant Patients)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice