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 | Terminated Phase 3 Results

• 4 other identifiers: GOG-0236NCI-2009-00602CDR0000579834U10CA101165
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

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

• Pain in Affected Limb

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

• Incidence of Deep-vein Thrombosis

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

• Incidence of Cellulitis

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

Study Arms (2)

Arm 1

EXPERIMENTAL

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; Other: Quality-of-Life Assessment

Arm II

EXPERIMENTAL

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

Procedure: Management of Therapy Complications; Other: Quality-of-Life Assessment

Interventions

Management of Therapy Complications PROCEDURE

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

Also known as: complications of therapy, management of

Arm 1

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm 1; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Lymphedema; Uterine Cervical Dysplasia; Vulvar Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Vulvar Diseases; Uterine Neoplasms

Results Point of Contact

• Title: Linda Gedeon for Helen Huang, MS.
• Organization: NRG Oncology

Linda.gedeon@roswellpark.org

716-845-1169

Study Officials

• Levi Downs

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 20, 2007
• Study Start: December 1, 2007
• Primary Completion: July 27, 2009
• Study Completion: July 27, 2009
• Last Updated: June 23, 2021
• Results First Posted: June 23, 2021

Record last verified: 2021-06

Locations

US (1)