Lymphedema, Stage 0 Cervical Cancer, Stage 0 Uterine Corpus Cancer, Stage 0 Vulvar Cancer, Stage IA Cervical Cancer, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage III Uterine Corpus Cancer, Stage III Vulvar Cancer, Stage II Uterine Corpus Cancer, Stage II Vulvar Cancer, Stage I Uterine Corpus Cancer, Stage IVA Cervical Cancer, Stage IVB Cervical Cancer, Stage IVB Vulvar Cancer, Stage I Vulvar Cancer, Stage IV Uterine Corpus Cancer
Conditions
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.
Interventions
PROCEDUREManagement of Therapy Complications
Receive standard home maintenance therapy and perform self-manual lymphatic drainage
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 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 | 0 |
| Arm II 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 | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study Terminated | 0 | 2 |
Baseline characteristics
| Characteristic | Arm II | Total | Arm 1 |
|---|---|---|---|
| Age, Customized 20-29 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 30-39 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Customized 40-49 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 50-59 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 60-69 years | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 2 |
| other Total, other adverse events | 0 / 0 | 0 / 2 |
| serious Total, serious adverse events | 0 / 0 | 0 / 2 |
Outcome results
Primary
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.
Time frame: From registration to study discontinuation. A maximum of 7 months.
Population: Eligible and evaluable participants. There were no evaluable participants due to low accrual.
Secondary
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.
Time frame: From registration to study discontinuation. A maximum of 7 months.
Secondary
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.
Time frame: From registration to study discontinuation. A maximum of 7 months.
Secondary
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.
Time frame: From registration to study discontinuation. A maximum of 7 months.
Secondary
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.
Time frame: From registration to study discontinuation. A maximum of 7 months.
Secondary
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.
Time frame: From registration to study discontinuation. A maximum of 7 months.
Secondary
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.
Time frame: From registration to study discontinuation. A maximum of 7 months.