Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema (AMWELL-SL)
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|ClinicalTrials.gov Identifier: NCT00828516|
Recruitment Status : Completed
First Posted : January 26, 2009
Results First Posted : January 17, 2013
Last Update Posted : January 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Head and Neck Cancer Lymphedema||Other: Acupuncture and moxibustion||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life for Patients With Upper Body Lymphoedema Secondary to Cancer Treatment|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||December 2009|
Experimental: Usual treatment plus acupuncture
Acupuncture and moxibustion, individualised according to participant priorities, delivered once weekly for 7 treatments (Series 1) followed by 6 treatments (Series 2) if participant wishes to continue treatment
Other: Acupuncture and moxibustion
Acupuncture is a form of traditional east Asian medicine that uses needles inserted superficially under the skin to stimulate sites on the body known as acupuncture points. Traditional practice encompasses moxibustion, the application of heat (usually from the smouldering herb artemisia vulgaris or mugwort) to stimulate the points by warming them.
- Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP) [ Time Frame: Before 7th acupuncture treatment ]MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.
- Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile [ Time Frame: Before the 13th acupuncture treatment ]MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.
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): NCT00828516
|Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre|
|Northwood, United Kingdom, HA6 2RN|
|Principal Investigator:||Beverley de Valois, PhD LicAc||Lynda Jackson Macmillan Centre at Mount Vernon Hospital|