Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Blood and Lymph Conditions

Rare Diseases

Uterine Cervical Neoplasms

Lymphedema

Vulvar Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lymphatic Diseases

Vulvar Diseases

Vulvar Cancer

Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.

Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks

Receive standard home maintenance therapy and perform self-manual lymphatic drainage

Management of Therapy Complications

Receive Flexitouch home maintenance therapy

Quality-of-Life Assessment

Levi Downs

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.

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.

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 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

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.

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.

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.

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.

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.

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.

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.

National Cancer Institute (NCI)

Gynecologic Oncology Group

Two participants enrolled in this study. The study was closed early due to poor accrual.

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 1

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

Arm II

Total

20-29 years

30-39 years

40-49 years

50-59 years

60-69 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Linda Gedeon for Helen Huang, MS.

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

Lower-extremity Volumes for Both Unaffected and Affected Legs

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT00577317	Lymphedema Stage 0 Cervica... Stage 0 Uterine... Stage 0 Vulvar ... Stage I Uterine... Stage I Vulvar ... Stage IA Cervic... Stage IB Cervic... Stage II Uterin... Stage II Vulvar... Stage IIA Cervi... Stage IIB Cervi... Stage III Cervi... Stage III Uteri... Stage III Vulva... Stage IV Uterin... Stage IVA Cervi... Stage IVB Cervi... Stage IVB Vulva...	Management of T... Management of T... Quality-of-Life...	18 Years -	GOG Foundation
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	NCT00577317	Lymphedema Stage 0 Cervica... Stage 0 Uterine... Stage 0 Vulvar ... Stage I Uterine... Stage I Vulvar ... Stage IA Cervic... Stage IB Cervic... Stage II Uterin... Stage II Vulvar... Stage IIA Cervi... Stage IIB Cervi... Stage III Cervi... Stage III Uteri... Stage III Vulva... Stage IV Uterin... Stage IVA Cervi... Stage IVB Cervi... Stage IVB Vulva...	Management of T... Management of T... Quality-of-Life...	18 Years -	GOG Foundation

Spots Global Cancer Trial Database for stage 0 uterine corpus cancer