Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema (AMWELL-SL)
This study has been completed.
Sponsor:
East and North Hertfordshire NHS Trust
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
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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:
MedlinePlus related topics:
Acupuncture
Acute Bronchitis
Benign Tumors
Breast Cancer
Cancer
Head and Neck Cancer
Lymphedema
Tonsils and Adenoids
U.S. FDA Resources
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
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:
No publications provided
| 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:
|
salivary gland acinic cell tumor 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 |
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 May 21, 2013