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History of Changes for Study: NCT00959985
Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer
Latest version (submitted April 26, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 14, 2009 None (earliest Version on record)
2 August 18, 2009 Recruitment Status, Study Status and Contacts/Locations
3 May 3, 2010 Study Status
4 January 24, 2012 Sponsor/Collaborators, Study Status, Outcome Measures, Eligibility and Study Identification
5 July 5, 2012 Study Status
6 January 7, 2013 Study Status
7 July 18, 2013 Study Status
8 May 6, 2014 Study Status
9 August 21, 2014 Recruitment Status, Study Status and Contacts/Locations
10 March 14, 2016 Study Status and Study Design
11 March 15, 2017 Study Status, Outcome Measures, Results, IPDSharing and Study Design
12 April 26, 2017 Outcome Measures and Study Status
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Study NCT00959985
Submitted Date:  August 14, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: 08-308
Brief Title: Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer
Official Title: Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer: A Randomized Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2009
Overall Status: Not yet recruiting
Study Start: August 2009
Primary Completion: August 2011 [Anticipated]
Study Completion:
First Submitted: August 14, 2009
First Submitted that
Met QC Criteria:
August 14, 2009
First Posted: August 17, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 14, 2009
Last Update Posted: August 17, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Massachusetts General Hospital
Responsible Party:
Collaborators: National Institutes of Health (NIH)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Women who have been treated for breast cancer may be at risk for lymphedema or arm swelling. Currently, there are no clear treatment guidelines for lymphedema. One treatment method used to treat lymphedema is the use of compression sleeves to encourage the flow of lymph fluid out of the arms and prevent arm swelling in the future. Another treatment method is more intensive and involves wearing compression sleeves as well as special compression bandages overnight. It is unclear whether the use of compression with both sleeves and bandaging is more effective in treating lymphedema than the use of compression sleeves alone. The purpose of this research study is to evaluate the effectiveness of the use of compression garments in preventing or slowing the progression of lymphedema in breast cancer patients.
Detailed Description:
  • Because no one knows which of the study options is best, participant's will be randomized into one of the study groups. Participants with mild lymphedema will be randomized into either Group 1A or Group 1B. Participants with moderate lymphedema will be randomized into either Group 2A or Group 2B.
  • All study participants will meet with a lymphedema physical therapist to review daily shoulder range of motion exercises to help minimize their arm swelling. They will be asked to record their range of motion exercises and activities in a study treatment journal. Participants will bring their journal to each study visit (every 4 weeks).
  • Group 1A will only be required to meet with the lymphedema physical therapist as described above.
  • Group 1B and Group 2A will be fitted with a compression sleeve at their first lymphedema physical therapy visit. They will wear the sleeve for a minimum of 12 hours per day.
  • Group 2B will also be fitted with a compression sleeve at their first lymphedema physical therapy visit and will wear the sleeve for a minimum of 12 hours per day. They will also be instructed to wear a short-stretch compression bandage that goes from the top of the hand to the armpit. They will be asked to wear this compression bandage during the night. The overnight compression bandage should be worn for at least 5 nights out of the week.
  • Participants will come to the clinic every 4 weeks. The following tests and procedures will be performed: height and weight measurements; review of any side effects; arm volume measurements for both arms; questionnaire.
Open or close this module Conditions
Conditions: Lymphedema
Breast Cancer
Keywords: compression sleeve
compression bandage
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 336 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
No Intervention: Group 1A
Mild Lymphedema: Only required to meet with the lymphedema physical therapist
Active Comparator: Group 1B
Mild Lymphedema: Fitted for compression sleeve
Device: Compression Sleeve
Worn for a minimum of 12 hours per day
Active Comparator: Group 2A
Moderate lymphedema: Fitted with a compression sleeve
Device: Compression Sleeve
Worn for a minimum of 12 hours per day
Active Comparator: Group 2B
Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Device: Compression Sleeve
Worn for a minimum of 12 hours per day
Device: Short-Stretch Compression Bandage
Worn overnight at least 5 nights of the week
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To assess the efficacy of early intervention using compression garments for low volume lymphedema associated with breast cancer treatment.
[ Time Frame: 2 years ]

2. To assess the efficacy of compression garments +/- night compression bandaging for moderate volume lymphedema due to breast cancer treatment, as a method for the alleviation of lymphedema.
[ Time Frame: 2 years ]

3. To assess symptom clusters, treatment adherence, fear avoidance behavior, quality of life, and upper extremity function as it is associated with varying degrees of lymphedema.
[ Time Frame: 2 years ]

Secondary Outcome Measures:
1. To identify risk factors associated with the onset of lymphedema that are both related and unrelated to treatment for breast cancer
[ Time Frame: 2 years ]

2. To evaluate and understand the natural history of lymphedema during and after treatment for breast cancer
[ Time Frame: 2 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast
  • Participants must have undergone sentinel lnode mapping or axillary dissection
  • Participants must have had a pre-operative Perometer measurement, and consecutive measurement at 4-6 month intervals prior to the onset of low volume edema (>5% from baseline)
  • Age > 18 years
  • Life expectancy of greater than 1 year
  • Participants must have a Perometer measurement of 5% or greater volume difference (RVC) to qualify for randomization
  • Ability to understand and willingness to sign a written informed consent document
  • Willingness to comply with required follow up Perometer measurements and clinical visits

Exclusion Criteria:

  • Known metastatic disease or other locally advanced disease in the thoracic or cervical regions
  • Any patient who will not be returning routinely for follow-up
  • Known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • History of primary lymphedema
  • History of prior surgery or radiation to the head, neck, upper limb, or trunk
  • Evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion
  • Any patient who has bilateral lymph node mapping or dissection
  • Any patient with a current case of cellulitis
  • Patients with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancer are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
Open or close this module Contacts/Locations
Central Contact Person: Alphonse G. Taghian, MD, PhD
Telephone: 617-726-6050
Study Officials: Alphonse G. Taghian, MD, PhD
Principal Investigator
Massachusetts General Hospital
Locations: United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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