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NCT00577317 · OUTCOME

Lower-extremity Volumes for Both Unaffected and Affected Legs

Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer · Source last updated 2021-06-23

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
From registration to study discontinuation. A maximum of 7 months.

What was measured

Volume for both lower extremities were going to be measured to determine if using the Flexi-touch was a more effective method to control lymphedema. Given that the study closed due to poor accrual (2 participants) analysis was not done.

Analysis population: Eligible and evaluable participants. There were no evaluable participants due to low accrual.

Groups in this outcome

Arm 1

Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks. Management of Therapy Complications: Receive standard home maintenance therapy and perform self-manual lymphatic drainage Quality-of-Life Assessment: Ancillary studies

Arm II

Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks Management of Therapy Complications: Receive Flexitouch home maintenance therapy Quality-of-Life Assessment: Ancillary studies

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 10
Arm II0

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
    units
    Participants
description
Volume for both lower extremities were going to be measured to determine if using the Flexi-touch was a more effective method to control lymphedema. Given that the study closed due to poor accrual (2 participants) analysis was not done.
groups
  1. description
    Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks. Management of Therapy Complications: Receive standard home maintenance therapy and perform self-manual lymphatic drainage Quality-of-Life Assessment: Ancillary studies
    id
    OG000
    title
    Arm 1
  2. description
    Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks Management of Therapy Complications: Receive Flexitouch home maintenance therapy Quality-of-Life Assessment: Ancillary studies
    id
    OG001
    title
    Arm II
population Description
Eligible and evaluable participants. There were no evaluable participants due to low accrual.
reporting Status
POSTED
time Frame
From registration to study discontinuation. A maximum of 7 months.
title
Lower-extremity Volumes for Both Unaffected and Affected Legs
type
PRIMARY

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

Preserved source evidence · Not medical advice