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

December 7, 2012 updated by: Beverley de Valois PhD LicAc FBAcC, East and North Hertfordshire NHS Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Northwood, United Kingdom, HA6 2RN
        • Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before 7th acupuncture treatment
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.
Before the 13th acupuncture treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East and North Hertfordshire NHS Trust

Collaborators

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

Investigators

  • Principal Investigator: Beverley de Valois, PhD LicAc, Lynda Jackson Macmillan Centre at Mount Vernon Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (Estimate)

January 26, 2009

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

December 7, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000632850
  • LJMC-AMWELL-SL (Other Grant/Funding Number: NIHR RISC PB-PG-0407-10086)
  • EU-20903

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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