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Completed

NCT Number: NCT00828516

Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Neoplasms, Male Carcinoma Carcinoma, Squamous Cell Cranial Nerve Diseases Esthesioneuroblastoma, Olfactory Head and Neck Cancer Head and Neck Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Olfactory Nerve Diseases Salivary Gland Diseases Salivary Gland Neoplasms Skin Diseases Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases Tongue Diseases Tongue Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre

Northwood, HA6 2RN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture and moxibustion

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.

Primary outcomes

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

    Time frame: Before 7th acupuncture treatment

    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.

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

    Time frame: Before the 13th acupuncture treatment

    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.

Sponsors and collaborators

Lead sponsor

East and North Hertfordshire NHS Trust

Other Gov

Collaborators

  • International Lymphoedema Framework
  • Lymphoedema Support Network
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • University of Exeter

Registry information

Official study title

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

Acronym: AMWELL-SL

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 26, 2009
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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