|No phase specified||Supportive care||Completed||18 and over||Other||CDR0000632850|
LJMC-AMWELL-SL, EU-20903, NCT00828516
RATIONALE: Acupuncture and moxibustion may improve well-being and quality of life in patients with lymphedema caused by breast cancer or head, neck, and throat cancer.
PURPOSE: This clinical trial is studying how well acupuncture given together with moxibustion works in improving well-being and quality of life in patients with breast cancer or head, neck, and throat cancer who are undergoing standard treatment for lymphedema.
Further Study Information
- To test the acupuncture and moxibustion treatment strategies to obtain a first measure of response for the approach(es) used in patients with breast cancer or head, neck, and throat cancer undergoing standard treatment for secondary lymphedema.
- To assess whether this treatment is an acceptable intervention to cancer patients with secondary lymphedema and to their health care professionals.
- To disseminate the data to begin to build the evidence base for using this treatment in the management of lymphedema.
OUTLINE: Patients undergo acupuncture and moxibustion therapy once weekly for 7 treatment (Series 1). After completion of therapy, patients may choose to continue treatment for an additional 6 treatments (Series 2).
Patients complete a set of 4 questionnaires (i.e., sociodemographic, Short-Form-36, Positive and Negative Affect Scale (PANAS), and Measure Yourself Medical Outcome Profile (MYMOP)) at the first treatment and then periodically during study. Patients also complete a series of follow-up questionnaires designed to elicit feedback about their acupuncture experience.
After completion of study treatment, patients are followed at 1 and 3 months.
- male or female patients with either breast or head and neck cancer
- diagnosis of mild to moderate uncomplicated lymphoedema
- age 18 or over
- under the care of the lymphoedema service for at leas:
- two months (head and neck cancer patients)
- three months (breast cancer patients)
- no active cancer disease
- at least 3 months since prior active cancer treatment (surgery, radiotherapy, chemotherapy, intravenous treatment)
- more than 6 months since prior acupuncture treatment
- concurrent adjuvant hormonal therapy allowed
- concurrent anti-depressant medication allowed provided there has been no change in prescription or dosing within the past 3 months and patient intends to remain on the medication for the duration of study treatment and follow-up
- Able to understand and communicate in English
- Able to travel to the Lynda Jackson Macmillan Centre for treatment
- Able to attend treatment once weekly for at least 7 consecutive weeks
- Able to complete outcome measures
- bilateral breast cancer
- advanced cancer disease
Trial Lead Organizations/Sponsors
Lister HospitalMount Vernon Cancer Centre at Mount Vernon Hospital
International Lymphoedema Framework
Lymphoedema Support Network
University of Exeter
|Beverley de Valois, PhD LicAc||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00828516
ClinicalTrials.gov processed this data on October 17, 2013
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