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Trial from ANZCTR

The effect of yoga on strength, range of motion and quality of life in women with secondary lymphoedema from breast cancer treatment. A randomised controlled pilot trial.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 28/2/2011)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12611000202965

Date registered

21 February 2011

Health condition

Secondary arm lymphoedema in breast cancer survivors

Recruitment countries

Australia

Recruitment site location(s) (State)

Tasmania

Recruitment status

Recruiting

Anticipated date of first participant enrolment

22 February 2011

Ethics application status

Approved

Brief summary

The lymphatic transport system provides the way for extra-cellular fluid and other substances to be transported back to the venous system. This fluid is taken up by lymph capillaries, flows into lymph collectors, then to lymph nodes in various parts of the body. Each part of the body flows to its own nodes eg fluid from the left arm will flow to the axilla under the left arm. In Australia a major cause for disruption to the lymphatic system is surgery and radiation therapy. Breast cancer treatment commonly includes modified radical mastectomy surgery, radiation to the chest wall, and removal of lymph nodes. These treatments all contribute to disruptions in lymphatic system function. Secondary arm lymphoedema after treatment from breast cancer occurs in at least 20% of women although this figure is usually quoted as being higher.

Research into the effects and benefits of different exercise modalities for women with secondary arm lymphoedema as a result of breast cancer treatment have shown that various types of exercise do not worsen lymphoedema - as long as the exercise is given in a supervised and controlled way, with adequate warm-up and cool-down. Women also report that attending a group exercise class helps keep them motivated to continue with their self-management regime. Recently, studies based on tai-chi and breathing and gentle exercises including breathing and relaxation, have led to slight decreases in the amount of fluid in the affected arm.

Yoga has been reported to lower levels of anxiety and depression and improve quality of life and immune function in women. However to date there has been no investigation on the effectiveness of yoga in the treatment of lympoedema.

This study will examine the effects of an eight week yoga intervention on lymphoedema in breast cancer survivors. A range of measures of degree of lympoedema, strength, range of motion and quality of life will be measured in women on commencement and after four and eight weeks of a yoga intervention and at four weeks after completion of the intervention. Results will be compared with a control group who receive usual care.

Eligibility

Key inclusion criteria

Women need to have completed all treatment for breast cancer at least 6 months previously;
Women need to comprehend English in order to understand the written forms, and oral instructions;
and have confirmed unilateral secondary lymphoedema related to surgery for breast cancer stage one, with volume being 10% greater than non-affected arm (dominant hand will be noted);

Minimum age

18 Years

Maximum age

0 No limit

Gender

Females

Key exclusion criteria

Women will be excluded if they have primary lymphoedema, recurrent cancer, other symptoms including infection or cellulitis as all of these will affect the woman’s lymphoedema and her quality of life adversely;
Women with severe psychological illness will be excluded as the yoga intervention needs to be specific to the person’s psychological illness in order to improve it;
Women with dementia and language problems will be excluded as they may not be able to fully comprehend the yoga instruction;
Pregnant women and women with pacemakers will be excluded as these conditions are contra-indicated for the use of bio-impedance spectroscopy – one of the measuring tools for this study (Czerniec et al 2010 p 55);
Women will be excluded if they are having current lymphoedema treatment other than self-management, as this will affect their results;
If women need lymphoedema treatment during the study they can continue in the study but measurements will not be analysed;
Women currently doing yoga or another intervention such as attending a local Encore group, due to the potential for the other treatment to affect the results, will also be excluded.

Contact details and further information

Primary Sponsor

Type: University
Name: University of Tasmania
Address: University Department of Rural Health
Locked Bag 1372
Launceston TAS 7250
Country: Australia

Contact person for information and recruitment

Tony Barnett
University Department of Rural Health
University of Tasmania
Locked Bag 1372
Launceston TAS 7250
Australia
+61 3 6324 4011
Tony.Barnett@utas.edu.au