Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 weeks. After completion of therapy, patients may choose to continue treatment for an additional 6 weeks.

Patients complete a set of 4 questionnaires (i.e., sociodemographic, Short-Form-36, Positive and Negative Affect Scale, and Measure Your Medical Outcome Profile) 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 week and 1 and 3 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of lymphedema secondary to one of the following:

• Breast cancer, meeting the following criteria:

• Underwent unilateral surgery only

• Diagnosis of mild to moderate uncomplicated lymphedema of the arm and/or midline (as assessed by the Macmillan Lymphedema Specialist at Mount Vernon Hospital [MVH])

• Managed by the Macmillan Lymphedema Specialist at MVH for at least 3 months

• Head, neck, or throat cancer meeting the following criteria:

• Any head, neck, or throat cancer site and diagnosis

• Managed by the Macmillan Lymphedema Specialist at MVH for at least 2 months

• No active or advanced disease

• Cellulitis allowed

PATIENT CHARACTERISTICS:

• 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 7 consecutive weeks

• Able to complete outcome measures

PRIOR CONCURRENT THERAPY:

• At least 3 months since prior active cancer treatment (including surgery, radiotherapy, chemotherapy, and 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre

Beverley de Valois

Principal Investigator

United Kingdom
	Northwood
	Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre
		Beverley de Valois	Ph: 44-1923-844-456

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00828516
Information obtained from ClinicalTrials.gov on January 23, 2012

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