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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00602 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000579834 | |||
| GOG-0236 | Other Identifier | Gynecologic Oncology Group | |
| GOG-0236 | Other Identifier | DCP | |
| GOG-0236 | Other Identifier | CTEP | |
| U10CA101165 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks. |
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| Arm II | Experimental | Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Management of Therapy Complications | Procedure | Receive standard home maintenance therapy and perform self-manual lymphatic drainage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From registration to study discontinuation. A maximum of 7 months. |
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Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Levi Downs | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
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Opened to accrual 12/26/2007 was terminated to enrollment on 7/21/2009 due to poor accrual. Target accrual was 262 patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Management of Therapy Complications | Procedure | Receive Flexitouch home maintenance therapy |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| 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. | 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. | 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. | 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. | 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. | From registration to study discontinuation. A maximum of 7 months. |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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Eligible and Evaluable subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Eligible and evaluable participants. There were no evaluable participants due to low accrual. | Posted | From registration to study discontinuation. A maximum of 7 months. |
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| 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. | Not Posted | From registration to study discontinuation. A maximum of 7 months. | Participants | ||||||||||||||||||||||||
| 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. | Not Posted | From registration to study discontinuation. A maximum of 7 months. | Participants | ||||||||||||||||||||||||
| 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. | Not Posted | From registration to study discontinuation. A maximum of 7 months. | Participants | ||||||||||||||||||||||||
| 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. | Not Posted | From registration to study discontinuation. A maximum of 7 months. | Participants | ||||||||||||||||||||||||
| 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. | Not Posted | From registration to study discontinuation. A maximum of 7 months. | Participants | ||||||||||||||||||||||||
| 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. | Not Posted | From registration to study discontinuation. A maximum of 7 months. | Participants |
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Two participants enrolled in this study. The study was closed early due to poor accrual.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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 | 0 | 2 | 0 | 2 | 0 | 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Gedeon for Helen Huang, MS. | NRG Oncology | 716-845-1169 | Linda.gedeon@roswellpark.org |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D002578 | Uterine Cervical Dysplasia |
| D014846 | Vulvar Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014845 | Vulvar Diseases |
| D014594 | Uterine Neoplasms |
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| Title | Measurements |
|---|---|
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| 40-49 years |
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| 50-59 years |
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| 60-69 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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