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

This study has been completed.
Sponsor:
Collaborators:
Mount Vernon Cancer Centre at Mount Vernon Hospital
International Lymphoedema Framework
Lymphoedema Support Network
University of Exeter
Information provided by (Responsible Party):
Beverley de Valois PhD LicAc FBAcC, East and North Hertfordshire NHS Trust
ClinicalTrials.gov Identifier:
NCT00828516
First received: January 23, 2009
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Head and Neck Cancer
Lymphedema
Other: Acupuncture and moxibustion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life for Patients With Upper Body Lymphoedema Secondary to Cancer Treatment

Resource links provided by NLM:


Further study details as provided by East and North Hertfordshire NHS Trust:

Primary Outcome Measures:
  • Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP) [ Time Frame: Before 7th acupuncture treatment ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile [ Time Frame: Before the 13th acupuncture treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 56
Study Start Date: April 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Usual treatment plus acupuncture
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
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828516

Locations
United Kingdom
Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre
Northwood, United Kingdom, HA6 2RN
Sponsors and Collaborators
East and North Hertfordshire NHS Trust
Mount Vernon Cancer Centre at Mount Vernon Hospital
International Lymphoedema Framework
Lymphoedema Support Network
University of Exeter
Investigators
Principal Investigator: Beverley de Valois, PhD LicAc Lynda Jackson Macmillan Centre at Mount Vernon Hospital
  More Information

Additional Information:
Publications:
de Valois B, Young T, Melsome E (2012) Assessing the feasibility of using acupuncture and moxibustion to improve quality of life for cancer survivors with upper body lymphoedema. European Journal of Oncology Nursing. 16:301-309

Responsible Party: Beverley de Valois PhD LicAc FBAcC, Research Acupuncturist, East and North Hertfordshire NHS Trust
ClinicalTrials.gov Identifier: NCT00828516     History of Changes
Other Study ID Numbers: CDR0000632850, LJMC-AMWELL-SL, EU-20903
Study First Received: January 23, 2009
Results First Received: November 9, 2012
Last Updated: December 7, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research

Keywords provided by East and North Hertfordshire NHS Trust:
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

Additional relevant MeSH terms:
Breast Neoplasms
Head and Neck Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on September 11, 2014