Back to resultsAcupuncture for the Treatment of Chronic Lymphedema
Primary Purpose
Breast Cancer, Lymphedema
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Lymphedema, Acupuncture, 09-136
Eligibility Criteria
Inclusion Criteria:
- Women age 18 or older willing to sign consent.
- Lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per Breast surgeon or medical oncologist.
- Patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years after diagnosis of chronic lymphedema.
- The affected arm must be >2cm larger than the unaffected arm; this is the standard diagnosis and the one used in the MSKCC studies cited above. The standard measurement techniques will be applied 20.
Exclusion Criteria:
- Previous acupuncture treatment for lymphedema
- Diuretic use
- History of primary (congenital) lymphedema
- Metastatic cancer
- History of autoimmune disorder (including lupus, rheumatoid arthritis, systemic sclerosis)
- History of other fibroproliferative disorder including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis/scleroderma
- Current treatment with corticosteroids
- Treatment with myelosuppressive or stimulatory drugs within 6 months of enrollment
- History of bone marrow transplantation
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acupuncture
Arm Description
Each patient will receive two acupuncture treatments each week for four consecutive weeks. At the end of four weeks, the intervention will be complete.
Outcomes
Primary Outcome Measures
To obtain preliminary evidence of the effects of acupuncture on chronic lymphedema due to breast cancer treatment.
Secondary Outcome Measures
To further evaluate the safety of acupuncture in this setting.
To obtain preliminary evidence of systemic immune changes that occur after acupuncture treatment of lymphedema.
Full Information
NCT ID
NCT01003951
First Posted
October 28, 2009
Last Updated
August 15, 2012
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01003951
Brief Title
Acupuncture for the Treatment of Chronic Lymphedema
Official Title
Acupuncture for the Treatment of Chronic Lymphedema: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
Brief Summary
Lymphedema is an accumulation of lymphatic fluid in the tissues that causes swelling, most often in the arms and/or legs, and occasionally in other parts of the body. Lymphedema can occur when lymph vessels are damaged or lymph nodes are removed. Lymphedema can develop right after breast cancer treatment or weeks, months, or even years later. For many people, available treatments for lymphedema are not effective. Recent evidence suggests that acupuncture may help reduce the symptoms of lymphedema. The purpose of this study is to determine the effects of acupuncture on chronic lymphedema. This study will look further at whether acupuncture can reduce lymphedema and help us to understand immune changes that may be associated with improvements in lymphedema.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lymphedema
Keywords
Lymphedema, Acupuncture, 09-136
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Each patient will receive two acupuncture treatments each week for four consecutive weeks. At the end of four weeks, the intervention will be complete.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture treatments will be given at the Integrative Medicine Outpatient Center, if needed in particular cases, at the MSKCC Breast Center. Each treatment is 30-40 minutes in duration. Each patient will receive two acupuncture treatments each week for four consecutive weeks.
Before and after each treatment, the circumference of the patient's upper arm, and forearm will be measured in both the affected and unaffected arms. The greater difference between affected and unaffected arms (either the forearm or the upper arm) for each patient will be used for outcome assessment. Photographs of the patient's affected and unaffected arms before and after each treatment will be taken to provide visual documentation of status. The patient's face will not appear in the photographs. Blood draws will be performed from the unaffected arm in serum collection tubes and will be performed within 1 week of starting acupuncture and within 1 week of completion of the 4 week protocol.
Primary Outcome Measure Information:
Title
To obtain preliminary evidence of the effects of acupuncture on chronic lymphedema due to breast cancer treatment.
Time Frame
twice weekly for four consecutive weeks and will be followed for an additional 6 months
Secondary Outcome Measure Information:
Title
To further evaluate the safety of acupuncture in this setting.
Time Frame
6 months to record any side effects that may occur post-treatment
Title
To obtain preliminary evidence of systemic immune changes that occur after acupuncture treatment of lymphedema.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women age 18 or older willing to sign consent.
Lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per Breast surgeon or medical oncologist.
Patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years after diagnosis of chronic lymphedema.
The affected arm must be >2cm larger than the unaffected arm; this is the standard diagnosis and the one used in the MSKCC studies cited above. The standard measurement techniques will be applied 20.
Exclusion Criteria:
Previous acupuncture treatment for lymphedema
Diuretic use
History of primary (congenital) lymphedema
Metastatic cancer
History of autoimmune disorder (including lupus, rheumatoid arthritis, systemic sclerosis)
History of other fibroproliferative disorder including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis/scleroderma
Current treatment with corticosteroids
Treatment with myelosuppressive or stimulatory drugs within 6 months of enrollment
History of bone marrow transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barrie Cassileth, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23576267
Citation
Cassileth BR, Van Zee KJ, Yeung KS, Coleton MI, Cohen S, Chan YH, Vickers AJ, Sjoberg DD, Hudis CA. Acupuncture in the treatment of upper-limb lymphedema: results of a pilot study. Cancer. 2013 Jul 1;119(13):2455-61. doi: 10.1002/cncr.28093. Epub 2013 Apr 10.
Results Reference
derived
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan-Kettering Cancer Center
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Acupuncture for the Treatment of Chronic Lymphedema
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