LymphedemaPhase 3NCT00577317

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

A Phase 3 study testing Management of Therapy Complications and Quality-of-Life Assessment in people with Lymphedema and Stage 0 Cervical Cancer, run by Gynecologic Oncology Group at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Lymphedema, Stage 0 Cervical Cancer, Stage 0 Uterine Corpus Cancer
What is being tested?: Management of Therapy Complications and Quality-of-Life Assessment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Dec 2007to 27 Jul 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Prospective Randomized Single Blind Phase III Trial Comparing Flexitouch Home Maintenance Therapy to Standard Home Maintenance Therapy for Lower Extremity Lymphedema Resulting From Treatment of Gynecologic Malignancy

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.

Read the detailed description

PRIMARY OBJECTIVE:

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:

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.

Conditions: Lymphedema, Stage 0 Cervical Cancer, Stage 0 Uterine Corpus Cancer, Stage 0 Vulvar Cancer, Stage I Uterine Corpus Cancer, Stage I Vulvar Cancer
Being tested: Management of Therapy Complications, Quality-of-Life Assessment
Medical subject headings: Lymphedema, Uterine Cervical Dysplasia, Vulvar Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Management of Therapy ComplicationsProcedure or surgery
Also called complications of therapy, management of
Receive standard home maintenance therapy and perform self-manual lymphatic drainage
Management of Therapy ComplicationsProcedure or surgery
Also called complications of therapy, management of
Receive Flexitouch home maintenance therapy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies

Study groups in NCT00577317
Study group	Role	What they receive
Arm 1	Experimental	Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks. Receives: Procedure: Management of Therapy Complications; Other: Quality-of-Life Assessment
Arm II	Experimental	Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks Receives: Procedure: Management of Therapy Complications; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire
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.
Measured: From registration to study discontinuation. A maximum of 7 months.
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
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.
Measured: From registration to study discontinuation. A maximum of 7 months.
Pain in Affected Limb
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.
Measured: From registration to study discontinuation. A maximum of 7 months.
Incidence of Deep-vein Thrombosis
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.
Measured: From registration to study discontinuation. A maximum of 7 months.
Incidence of Cellulitis
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.
Measured: From registration to study discontinuation. A maximum of 7 months.
Need for Unscheduled Visits at the Patients' Lymphedema Clinic
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.
Measured: From registration to study discontinuation. A maximum of 7 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 200727 Jul 2009

First posted20 Dec 2007 (estimated)
Study startDec 2007
Primary completion27 Jul 2009
Study completion27 Jul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for LymphedemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00577317
Sponsor's protocol ID: GOG-0236
Other IDs: NCI-2009-00602, CDR0000579834, GOG-0236, GOG-0236, GOG-0236, U10CA101165
Status last verified: Jun 2021
First submitted: 19 Dec 2007
Last updated: 23 Jun 2021
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm

All Lymphedema trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Randomized Single Blind Phase III Trial Comparing Flexitouch Home Maintenance Therapy to Standard Home Maintenance Therapy for Lower Extremity Lymphedema Resulting From Treatment of Gynecologic Malignancy
ClinicalTrials.gov ID: NCT00577317
Acronym / sponsor ID: GOG-0236
Conditions: Lymphedema, Stage 0 Cervical Cancer, Stage 0 Uterine Corpus Cancer, Stage 0 Vulvar Cancer, Stage I Uterine Corpus Cancer, Stage I Vulvar Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 2 participants (actual)
Lead sponsor: Gynecologic Oncology GroupResearch network
Collaborators: National Cancer Institute (NCI)
Study start: Dec 2007
Primary completion: 27 Jul 2009 (actual)
Study completion: 27 Jul 2009 (actual)
First posted: 20 Dec 2007 (estimated)
Results: Posted 23 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

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:

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

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Procedure: Management of Therapy Complications, Other: Quality-of-Life AssessmentPatients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.
Arm II	Experimental	Procedure: Management of Therapy Complications, Other: Quality-of-Life AssessmentPatients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Management of Therapy ComplicationsAlso: complications of therapy, management ofReceive standard home maintenance therapy and perform self-manual lymphatic drainage	Procedure or surgery	Arm 1
Management of Therapy ComplicationsAlso: complications of therapy, management ofReceive Flexitouch home maintenance therapy	Procedure or surgery	Arm II
Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies	Other	Arm 1, Arm II

Primary outcome

Lower-extremity Volumes for Both Unaffected and Affected Legs
Time frame: From registration to study discontinuation. A maximum of 7 months.
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.

6 secondary outcomes

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.
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.
Pain in Affected Limb
Time frame: From registration to study discontinuation. A maximum of 7 months.
Incidence of Deep-vein Thrombosis
Time frame: From registration to study discontinuation. A maximum of 7 months.
Incidence of Cellulitis
Time frame: From registration to study discontinuation. A maximum of 7 months.
Need for Unscheduled Visits at the Patients' Lymphedema Clinic
Time frame: From registration to study discontinuation. A maximum of 7 months.

Results and safety

Results posted to the registry on 23 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1	0	0
Arm II	2	0

Primary outcome: Lower-extremity Volumes for Both Unaffected and Affected Legs

Time frame: From registration to study discontinuation. A maximum of 7 months.

Population analysed: Eligible and evaluable participants. There were no evaluable participants due to low accrual.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1	0 of 0	0 of 0	0
Arm II	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lymphedema

Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Levi Downs principal investigator

Gynecologic Oncology Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lower-extremity Volumes for Both Unaffected and Affected Legs (time frame: From registration to study discontinuation. A maximum of 7 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00577317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.