Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema (AMWELL-SL)

East and North Hertfordshire NHS Trust

Status: Completed

Conditions: Breast Cancer; Lymphedema; Head and Neck Cancer

Treatments: Other: Acupuncture and moxibustion

Study type: Interventional

Funder types: Other

Identifiers

NCT00828516

CDR0000632850

EU-20903

LJMC-AMWELL-SL (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• bilateral breast cancer
• advanced cancer disease

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Usual treatment plus acupuncture

Experimental group

Description:

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

Treatment:

Other: Acupuncture and moxibustion