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

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00577317
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 2
• Location: 1
• Arms: 2
• Duration (Months): 19.8
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphedema; Stage 0 Cervical Cancer; Stage 0 Uterine Corpus Cancer; Stage 0 Vulvar Cancer; Stage I Uterine Corpus Cancer; Stage I Vulvar Cancer; Stage IA Cervical Cancer; Stage IB Cervical Cancer; Stage II Uterine Corpus Cancer; Stage II Vulvar Cancer; Stage IIA Cervical Cancer; Stage IIB Cervical Cancer; Stage III Cervical Cancer; Stage III Uterine Corpus Cancer; Stage III Vulvar Cancer; Stage IV Uterine Corpus Cancer; Stage IVA Cervical Cancer; Stage IVB Cervical Cancer; Stage IVB Vulvar Cancer	Procedure: Management of Therapy Complications; Procedure: Management of Therapy Complications; Other: Quality-of-Life Assessment	Phase 3

Detailed Description

PRIMARY OBJECTIVE:

1. 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:

1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• 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
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Jul 27, 2009
• Actual Study Completion Date: Jul 27, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.	Procedure: Management of Therapy Complications; Receive standard home maintenance therapy and perform self-manual lymphatic drainage; Other Names: complications of therapy, management of ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment
Experimental: Arm II Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks	Procedure: Management of Therapy Complications; Receive Flexitouch home maintenance therapy; Other Names: complications of therapy, management of ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment

Outcome Measures

Primary Outcome Measures

1. Lower-extremity Volumes for Both Unaffected and Affected Legs [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.

Secondary Outcome Measures

1. Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire [From registration to study discontinuation. A maximum of 7 months.]

   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.

2. 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 [From registration to study discontinuation. A maximum of 7 months.]

   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.

3. Pain in Affected Limb [From registration to study discontinuation. A maximum of 7 months.]

   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.

4. Incidence of Deep-vein Thrombosis [From registration to study discontinuation. A maximum of 7 months.]

   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.

5. Incidence of Cellulitis [From registration to study discontinuation. A maximum of 7 months.]

   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.

6. Need for Unscheduled Visits at the Patients' Lymphedema Clinic [From registration to study discontinuation. A maximum of 7 months.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynecologic Oncology Group	Philadelphia	Pennsylvania	United States	19103

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Levi Downs, Gynecologic Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT00577317
• Other Study ID Numbers: GOG-0236; NCI-2009-00602; CDR0000579834; GOG-0236; GOG-0236; GOG-0236; U10CA101165
• First Posted: Dec 20, 2007
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Vulvar Neoplasms; Lymphedema

Study Results

Participant Flow

Recruitment Details	Opened to accrual 12/26/2007 was terminated to enrollment on 7/21/2009 due to poor accrual. Target accrual was 262 patients.

Arm/Group Title	Arm 1	Arm II
Arm/Group 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	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
Period Title: Overall Study
STARTED	0	2
COMPLETED	0	0
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Arm 1	Arm II	Total
Arm/Group 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	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	Total of all reporting groups
Overall Participants	0	2	2
Age, Customized (Count of Participants)
20-29 years	0 NaN	0 0%	0 0%
30-39 years	0 NaN	1 50%	1 50%
40-49 years	0 NaN	0 0%	0 0%
50-59 years	0 NaN	0 0%	0 0%
60-69 years	0 NaN	1 50%	1 50%
Sex: Female, Male (Count of Participants)
Female	0 NaN	2 100%	2 100%
Male	0 NaN	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 NaN	0 0%	0 0%
Not Hispanic or Latino	0 NaN	1 50%	1 50%
Unknown or Not Reported	0 NaN	1 50%	1 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 NaN	0 0%	0 0%
Asian	0 NaN	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 NaN	0 0%	0 0%
Black or African American	0 NaN	0 0%	0 0%
White	0 NaN	2 100%	2 100%
More than one race	0 NaN	0 0%	0 0%
Unknown or Not Reported	0 NaN	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Arm 1	Arm II
Arm/Group 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	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
Measure Participants	0	0

2. Secondary Outcome

Title	Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire
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.
Time Frame	From registration to study discontinuation. A maximum of 7 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	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
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.
Time Frame	From registration to study discontinuation. A maximum of 7 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Pain in Affected Limb
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.
Time Frame	From registration to study discontinuation. A maximum of 7 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Incidence of Deep-vein Thrombosis
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.
Time Frame	From registration to study discontinuation. A maximum of 7 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Incidence of Cellulitis
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.
Time Frame	From registration to study discontinuation. A maximum of 7 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Need for Unscheduled Visits at the Patients' Lymphedema Clinic
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.
Time Frame	From registration to study discontinuation. A maximum of 7 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Adverse Event Reporting Description	Two participants enrolled in this study. The study was closed early due to poor accrual.
Arm/Group Title	Arm 1		Arm II
Arm/Group 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		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
All Cause Mortality
	Arm 1		Arm II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/2 (0%)
Serious Adverse Events
	Arm 1		Arm II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1		Arm II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.