NCT00577317 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: TERMINATED
Registry last update: 2021-06-23

This randomized phase III trial is studying Flexitouch® home maintenance therapy to see how well it works compared with standard home maintenance therapy in treating patients with lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or endometrial cancer. Flexitouch® home maintenance therapy may lessen lower-extremity lymphedema caused by treatment for gynecologic cancer. It is not yet known whether the Flexitouch® system is more effective than standard home maintenance therapy in treating lymphedema.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Lower-extremity Volumes for Both Unaffected and Affected Legs

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outcome · NOT POSTED

Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire

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outcome · NOT POSTED

Compliance With Treatment as Assessed by the Number of Days Per Week Using MLD or Flexitouch System and Duration/Day of MLD and Flexitouch System Treatment

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outcome · NOT POSTED

Pain in Affected Limb

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outcome · NOT POSTED

Incidence of Deep-vein Thrombosis

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outcome · NOT POSTED

Incidence of Cellulitis

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outcome · NOT POSTED

Need for Unscheduled Visits at the Patients' Lymphedema Clinic

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Criteria: * Has lower-extremity lymphedema on one side of the body caused by surgery, chemotherapy, and/or radiation therapy. * At least 6 months since clinic therapy for lower-extremity lymphedema * Is within 3 years from finishing cancer treatment * No active or recurrent cancer * More than 3 months since cancer treatment
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.
intervention Names
Procedure: Management of Therapy Complications
Other: Quality-of-Life Assessment
label
Arm 1
type
EXPERIMENTAL
description
Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks
intervention Names
Procedure: Management of Therapy Complications
Other: Quality-of-Life Assessment
label
Arm II
type
EXPERIMENTAL

interventions

arm Group Labels
Arm 1
description
Receive standard home maintenance therapy and perform self-manual lymphatic drainage
name
Management of Therapy Complications
other Names
complications of therapy, management of
type
PROCEDURE
arm Group Labels
Arm II
description
Receive Flexitouch home maintenance therapy
name
Management of Therapy Complications
other Names
complications of therapy, management of
type
PROCEDURE
arm Group Labels
Arm 1
Arm II
description
Ancillary studies
name
Quality-of-Life Assessment
other Names
Quality of Life Assessment
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: SINGLE
who Masked: PARTICIPANT

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 2
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Lower-extremity Volumes for Both Unaffected and Affected Legs
time Frame
From registration to study discontinuation. A maximum of 7 months.

secondary Outcomes

description
Quality of life was to be assessed to compare QOL between arms. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.
measure
Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire
time Frame
From registration to study discontinuation. A maximum of 7 months.
description
Compliance with treatment was to be measured between both arms of the study. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.
measure
Compliance With Treatment as Assessed by the Number of Days Per Week Using MLD or Flexitouch System and Duration/Day of MLD and Flexitouch System Treatment
time Frame
From registration to study discontinuation. A maximum of 7 months.
description
Pain in affected limb was to be measured. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.
measure
Pain in Affected Limb
time Frame
From registration to study discontinuation. A maximum of 7 months.
description
Incidence of deep-vein thrombosis was to be measured during the study. Unfortunately, due to low accrual study was closed. Analysis will not be performed.
measure
Incidence of Deep-vein Thrombosis
time Frame
From registration to study discontinuation. A maximum of 7 months.
description
Incidence of cellulitis in both arms was planned to measured. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.
measure
Incidence of Cellulitis
time Frame
From registration to study discontinuation. A maximum of 7 months.
description
The need for unscheduled visits at the patient's lymphedema clinic was going to be analyzed. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.
measure
Need for Unscheduled Visits at the Patients' Lymphedema Clinic
time Frame
From registration to study discontinuation. A maximum of 7 months.

Full study description

brief Summary: This randomized phase III trial is studying Flexitouch® home maintenance therapy to see how well it works compared with standard home maintenance therapy in treating patients with lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or endometrial cancer. Flexitouch® home maintenance therapy may lessen lower-extremity lymphedema caused by treatment for gynecologic cancer. It is not yet known whether the Flexitouch® system is more effective than standard home maintenance therapy in treating lymphedema.
detailed Description: PRIMARY OBJECTIVE: I. Compare the effectiveness of the Flexitouch® System to standard home lymphedema therapy (Manual Lymphatic Drainage) in the management of lower-extremity lymphedema in women with a history of cervical, vulvar, or endometrial cancer. SECONDARY OBJECTIVE: I. Compare the quality of life (QOL) and functional status between patients using the Flexitouch® System and those following standard home lymphedema treatment (Manual Lymphatic Drainage) programs in the management of lower-extremity lymphedema OUTLINE: This is a multicenter study. Patients are stratified according to site of cancer (cervical vs vulvar vs endometrial) and stage of lymphedema at diagnosis. Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks. ARM II: Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks. Clinical staff measure patients' lower limb (both) volumes and patients complete quality of life questionnaires at baseline, every 8 weeks during treatment, and at completion of study treatment.

Source references

Source notices and limitations

Discovery and provenance

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exact text
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start
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query cond
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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice