Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema

Breast Cancer Clinical Trial

— AMWELL-SL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828516
• Other study ID #: CDR0000632850
• Secondary ID: LJMC-AMWELL-SLEU
• Status: Completed
• Phase: N/A
• First received: January 23, 2009
• Last updated: December 7, 2012
• Start date: April 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2012
• Source: East and North Hertfordshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lymphedema

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre	Northwood

Sponsors (5)

Lead Sponsor	Collaborator
East and North Hertfordshire NHS Trust	International Lymphoedema Framework, Lymphoedema Support Network, Mount Vernon Cancer Centre at Mount Vernon Hospital, University of Exeter

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

de Valois B and Peckham R (2011) Treating the person and not the disease: acupuncture in the management of cancer treatment-related lymphoedema. European Journal of Oriental Medicine, 6(6), 37-49.

de Valois B, Young T, Melsome E (2011) Acupuncture in lymphoedema management: a feasibility study. Journal of Lymphoedema. 6(2) 20-31.

de Valois BA, Young TE, Melsome E. Assessing the feasibility of using acupuncture and moxibustion to improve quality of life for cancer survivors with upper body lymphoedema. Eur J Oncol Nurs. 2012 Jul;16(3):301-9. doi: 10.1016/j.ejon.2011.07.005. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No