NCT00828516 · REGISTRY CONDITION SEARCH

Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2013-01-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)

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outcome · POSTED

Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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 Names
Other: Acupuncture and moxibustion
label
Usual treatment plus acupuncture
type
EXPERIMENTAL

interventions

arm Group Labels
Usual treatment plus acupuncture
description
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.
name
Acupuncture and moxibustion
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 56
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)
time Frame
Before 7th acupuncture treatment
description
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.
measure
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile
time Frame
Before the 13th acupuncture treatment

Full study description

brief 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.
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.

Source references

references

citation
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.
type
BACKGROUND
citation
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 2011 Sep 13.
pmid
21917515
type
RESULT
citation
de Valois B, Young T, Melsome E (2011) Acupuncture in lymphoedema management: a feasibility study. Journal of Lymphoedema. 6(2) 20-31.
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice