Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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OBJECTIVES:

* 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.

Conditions

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Breast Cancer Head and Neck Cancer Lymphedema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Acupuncture and moxibustion

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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