Trial Outcomes & Findings for 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 (NCT NCT00577317)
NCT ID: NCT00577317
Last Updated: 2021-06-23
Results Overview
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.
TERMINATED
PHASE3
2 participants
From registration to study discontinuation. A maximum of 7 months.
2021-06-23
Participant Flow
Opened to accrual 12/26/2007 was terminated to enrollment on 7/21/2009 due to poor accrual. Target accrual was 262 patients.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Study Terminated
|
0
|
2
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
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
|
Arm II
n=2 Participants
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
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-29 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
30-39 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Customized
40-49 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
50-59 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
60-69 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From registration to study discontinuation. A maximum of 7 months.Population: Eligible and evaluable participants. There were no evaluable participants due to low accrual.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1
Arm II
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60