Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema

East and North Hertfordshire NHS Trust56 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer Head and Neck Cancer Lymphedema

Interventions

Acupuncture and moxibustionOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre

Northwood, United Kingdom

Outcomes

Primary Outcomes

Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)

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.

Time frame: Before 7th acupuncture treatment

Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile

Time frame: Before the 13th acupuncture treatment

Data from ClinicalTrials.gov

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