Flexitouch Lymphedema System in Treating Stage II Lymphedema in Patients With Breast Cancer
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| ClinicalTrials.gov Identifier: NCT01019512 |
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Recruitment Status :
Terminated
First Posted : November 24, 2009
Last Update Posted : March 25, 2015
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Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Information provided by:
Abramson Cancer Center of the University of Pennsylvania
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Brief Summary:
RATIONALE: The Flexitouch lymphedema system may lessen lymphedema caused by treatment for breast cancer. It is not yet known whether the Flexitouch lymphedema system is more effective than complex decongestive therapy in treating lymphedema. PURPOSE: This randomized clinical trial is studying the Flexitouch lymphedema system in treating stage II lymphedema in patients with breast cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Lymphedema | Other: questionnaire administration Other: lymphedema management | Not Applicable |
PRIMARY OBJECTIVES: I. To quantitatively assess, by circumferential measurements and CT imaging techniques, the ability of the Flexitouch Lymphedema System to maintain reductions in limb volume after completion of the reductive phase of complex decongestive therapy in a population of patients with upper limb lymphedema secondary to the effects of breast cancer treatment. SECONDARY OBJECTIVES: I. To determine the drainage territory of the lymphatics of the affected arm and chest using CT and to determine whether these patterns are changed by treatment with the Flexitouch Lymphedema System/daytime garments versus Flexitouch Lymphedema System/daytime garments/nighttime bandaging versus standard self-care. OUTLINE: Patients are randomized to 1 of 3 treatment arms. Arm I: Patients undergo complex decongestive therapy comprising daily compression garment (sleeve and glove) use, daily manual lymphatic drainage (self-administered), and nighttime bandaging with low stretch Comprilan bandages. Arm II: Patients undergo daily compression with garments (sleeve and glove), nighttime bandaging with low stretch Comprilan bandages, and daily Flexitouch treatment over 1 hour every evening. Arm III: Patients undergo daily compression with garments (sleeve and glove) and daily Flexitouch treatment over 1 hour every evening. In all arms, treatment continues for 3 months.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Pilot, Randomized, Single-Blind Study to Assess the Efficacy of the Flexitouch® Lymphedema System in Reducing Lymphedema in Patients Treated for Breast Cancer |
| Study Start Date : | July 2009 |
| Actual Primary Completion Date : | January 2011 |
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| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm I
Patients undergo complex decongestive therapy comprising daily compression garment (sleeve and glove) use, daily manual lymphatic drainage (self-administerd), and nighttime bandaging with low stretch Comprilan bandages.
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Other: questionnaire administration
Ancillary studies Other: lymphedema management |
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Experimental: Arm II
Patients undergo daily compression with garments (sleeve and glove), nighttime bandaging with low stretch Comprilan bandages, and daily Flexitouch treatment over 1 hour every evening.
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Other: questionnaire administration
Ancillary studies Other: lymphedema management |
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Experimental: Arm III
Patients undergo daily compression with garments (sleeve and glove) and daily Flexitouch treatment over 1 hour every evening.
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Other: questionnaire administration
Ancillary studies Other: lymphedema management |
Primary Outcome Measures :
- Upper extremity volume measured by circumferential measurements and by CT imaging [ Time Frame: At baseline, monthly for 3 months (circumferential measurements only), and end of study ]
- Signs and symptoms of acute infection
Secondary Outcome Measures :
- Weight [ Time Frame: At baseline and then monthly for 3 months ]
- BMI [ Time Frame: At baseline and then monthly for 3 months ]
- Upper body function, based on the Disability of Arm, Shoulder, and Hand Scale (DASH) [ Time Frame: At baseline and then monthly for 3 months ]
- Functional assessment, based on the Functional Assessment of Cancer Therapy Breast + 4 (FACT+4) [ Time Frame: At baseline and then monthly for 3 months ]
- Quality of life, based on the Functional Assessment of Cancer Therapy Breast (FACT-B) [ Time Frame: At baseline and then monthly for 3 months ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion
- Subjects must have a known, clinical diagnosis of stage II lymphedema as verified by a physician specializing in this disorder
- Subjects must have had a unilateral mastectomy, lymph node (LN) dissection and/or radiation therapy for the treatment of primary breast cancer
- Subjects must have completed their course of adjuvant chemotherapy
- Clinical assessment of lymphedema demonstrating at least 10% difference between the volumes of the affected and opposite limbs at the time of enrollment
- Subjects must be completing phase I of their CDT for their initial onset of lymphedema or for an acute flare of lymphedema
- Subjects must be capable of giving informed consent Exclusion
- History of prior trauma and/or surgery in the affected limb other than that for treatment of breast cancer
- Patients with recurrent breast cancer
- History of bilateral breast cancer
- Subjects currently receiving other therapies for lymphedema
- Subjects with renal, liver, and/or heart dysfunction
- Open wounds or web syndrome
- Active/acute infection (cellulitis)
- Acute DVT/Thrombophlebitis
- Decompensated or untreated congestive heart failure
- Pulmonary embolism - Pregnancy as confirmed by urine test; all patients of child bearing potential will be required to have a urine pregnancy test
- Subjects cannot be homeless persons
- Concomitant chemotherapy and radiation treatment during this study is not permitted
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019512
Locations
| United States, Pennsylvania | |
| Abramson Cancer Center of The University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
| Principal Investigator: | Abass Alavi | Abramson Cancer Center of the University of Pennsylvania |
| Responsible Party: | Alavi, Abass, Abramson Cancer Center of The University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01019512 History of Changes |
| Other Study ID Numbers: |
UPCC 02109 NCI-2009-01415 |
| First Posted: | November 24, 2009 Key Record Dates |
| Last Update Posted: | March 25, 2015 |
| Last Verified: | March 2015 |
Additional relevant MeSH terms:
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Breast Neoplasms Lymphedema Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Lymphatic Diseases |