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

January 23, 2009
December 7, 2012
April 2008
September 2009   (final data collection date for primary outcome measure)
  • 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.
  • Acupuncture and moxibustion treatment strategies (Acu/Moxa) in promoting well-being and improving quality of life [ Designated as safety issue: No ]
  • Acu/Moxa as an acceptable intervention to cancer patients with secondary lymphedema and their health care professionals [ Designated as safety issue: No ]
  • Evidence base for using Acu/Moxa in management of lymphedema [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00828516 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema
Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life for Patients With Upper Body Lymphoedema Secondary to Cancer Treatment

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Head and Neck Cancer
  • Lymphedema
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.
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
Intervention: Other: Acupuncture and moxibustion
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
December 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00828516
CDR0000632850, LJMC-AMWELL-SL, EU-20903
No
Beverley de Valois PhD LicAc FBAcC, East and North Hertfordshire NHS Trust
East and North Hertfordshire NHS Trust
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • International Lymphoedema Framework
  • Lymphoedema Support Network
  • University of Exeter
Principal Investigator: Beverley de Valois, PhD LicAc Lynda Jackson Macmillan Centre at Mount Vernon Hospital
East and North Hertfordshire NHS Trust
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP