Breast CancerNCT01019512
Flexitouch Lymphedema System in Treating Stage II Lymphedema in Patients With Breast Cancer
A study testing questionnaire administration and lymphedema management in people with Breast Cancer and Lymphedema, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- questionnaire administration and lymphedema management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- questionnaire administration, lymphedema management
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Ancillary studies
lymphedema managementOther
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | 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. Receives: Other: questionnaire administration; Other: lymphedema management |
| Arm II | Experimental | 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. Receives: Other: questionnaire administration; Other: lymphedema management |
| Arm III | Experimental | Patients undergo daily compression with garments (sleeve and glove) and daily Flexitouch treatment over 1 hour every evening. Receives: Other: questionnaire administration; Other: lymphedema management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity volume measured by circumferential measurements and by CT imaging
Measured: At baseline, monthly for 3 months (circumferential measurements only), and end of study
Signs and symptoms of acute infection
Secondary outcomes (5)
Weight
Measured: At baseline and then monthly for 3 months
BMI
Measured: At baseline and then monthly for 3 months
Upper body function, based on the Disability of Arm, Shoulder, and Hand Scale (DASH)
Measured: At baseline and then monthly for 3 months
Functional assessment, based on the Functional Assessment of Cancer Therapy Breast + 4 (FACT+4)
Measured: At baseline and then monthly for 3 months
Quality of life, based on the Functional Assessment of Cancer Therapy Breast (FACT-B)
Measured: At baseline and then monthly for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Abass Alavi, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019512
- Sponsor's protocol ID
- UPCC 02109
- Other IDs
- NCI-2009-01415
- Status last verified
- Mar 2015
- First submitted
- 23 Nov 2009
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01019512
- Acronym / sponsor ID
- UPCC 02109
- Conditions
- Breast Cancer, Lymphedema
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jan 2011 (actual)
- First posted
- 24 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Other: questionnaire administration, Other: lymphedema managementPatients 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. |
| Arm II | Experimental | Other: questionnaire administration, Other: lymphedema managementPatients 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 | Experimental | Other: questionnaire administration, Other: lymphedema managementPatients undergo daily compression with garments (sleeve and glove) and daily Flexitouch treatment over 1 hour every evening. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administrationAncillary studies | Other | Arm I, Arm II, Arm III |
| lymphedema management | Other | Arm I, Arm II, Arm III |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abass Alavi principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration and lymphedema management in people with Breast Cancer and Lymphedema, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.