Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema

Study Overview
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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.

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.

Official Title
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Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life for Patients With Upper Body Lymphoedema Secondary to Cancer Treatment

Conditions
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Breast Cancer, Head and Neck Cancer, Lymphedema

Intervention / Treatment
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* Other: Acupuncture and moxibustion


Participation Criteria
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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 EXCLUSION CRITERIA: bilateral breast cancer advanced cancer disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual treatment plus acupuncture<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Before 7th acupuncture treatment | 
| Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile | 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. | Before the 13th acupuncture treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphedema, male breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, recurrent breast cancer, recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, recurrent adenoid cystic carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent verrucous carcinoma of the oral cavity, stage I adenoid cystic carcinoma of the oral cavity, stage I mucoepidermoid carcinoma of the oral cavity, stage I verrucous carcinoma of the oral cavity, stage II adenoid cystic carcinoma of the oral cavity, stage II mucoepidermoid carcinoma of the oral cavity, stage II verrucous carcinoma of the oral cavity, stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, recurrent squamous cell carcinoma of the lip and oral cavity, stage I basal cell carcinoma of the lip, stage II basal cell carcinoma of the lip, recurrent metastatic squamous neck cancer with occult primary, recurrent lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage I lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage I lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II lymphoepithelioma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage I inverted papilloma of the paranasal sinus and nasal cavity, stage I midline lethal granuloma of the paranasal sinus and nasal cavity, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage II inverted papilloma of the paranasal sinus and nasal cavity, stage II midline lethal granuloma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, low-grade salivary gland mucoepidermoid carcinoma, recurrent salivary gland cancer, salivary gland acinic cell tumor, salivary gland adenocarcinoma, salivary gland adenoid cystic carcinoma, salivary gland anaplastic carcinoma, salivary gland malignant mixed cell type tumor, salivary gland poorly differentiated carcinoma, salivary gland squamous cell carcinoma, stage I salivary gland cancer, stage II salivary gland cancer, tongue cancer