ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000202965

Ethics application status

Approved

Date submitted

18/02/2011

Date registered

21/02/2011

Date last updated

28/02/2011

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of yoga on women with secondary lymphoedema from breast cancer treatment. A pilot trial.

Scientific title

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.

Secondary ID [1]

University of Tasmania Social Sciences Human Research Ethics Committee H11534

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Secondary arm lymphoedema in breast cancer survivors

Condition category

Condition code

Cancer

Breast

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

An eight week yoga intervention consisting of one 90 minute supervised and six 45 minute home based yoga classes per week. The type of yoga is Hatha yoga based on Satyananda teachings. The supervised session will be conducted in groups consisting of 5-12 participants.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Comparator / control treatment

Usual care consists of manual lymphatic drainage if required and current best practice self management including treatments such as personal skin care, self massage, specific exercises and elevation of the arm.

Control group

Active

Outcomes

Primary outcome [1]

Arm lymphoedema via measurements of arm volume, bio-impedance and tonometer measurements

Timepoint [1]

baseline, week 4, week 8 and 4 weeks post intervention

Secondary outcome [1]

Shoulder range of motion using goniometry

Timepoint [1]

baseline, week 4, week 8 and 4 weeks post intervention

Secondary outcome [2]

Isometric shoulder and grip strength using dynamometry

Timepoint [2]

baseline, week 4, week 8 and 4 weeks post intervention

Secondary outcome [3]

Spinal mobility felxion/extension, lateral flexion and rotation) using an opto electronic motion analysis system for calculation of angles of motion.

Timepoint [3]

baseline, week 4, week 8 and 4 weeks post intervention

Secondary outcome [4]

Quality of Life Questionnaire - LYMQOL

Timepoint [4]

baseline, week 4, week 8 and 4 weeks post intervention

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

No limit

Sex

Females

Can healthy volunteers participate?

No

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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Treatment allocated by a third party not involved in the study.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation by coin-toss

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

22/02/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

40

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Recruitment postcode(s) [1]

7250

Recruitment postcode(s) [2]

7005

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

University of Tasmania

Address

University Department of Rural Health
Locked Bag 1372
Launceston TAS 7250

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Social Sciences Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

16/12/2010

Ethics approval number [1]

H11534

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Tony Barnett

Address

University Department of Rural Health
University of Tasmania
Locked Bag 1372
Launceston TAS 7250

Country

Australia

Phone

+61 3 6324 4011

Fax

+61 3 6324 4040

Email

Tony.Barnett@utas.edu.au

Contact person for scientific queries

Name

Tony Barnett

Address

University Department of Rural Health
University of Tasmania
Locked Bag 1372
Launceston TAS 7250

Country

Australia

Phone

+61 3 6324 4011

Fax

Email

Tony.Barnett@utas.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Loudon A, T Barnett, N Piller, MA Immink and AD Wi... [More Details]
Study results article	Yes		Loudon A, T Barnett, N Piller, MA Immink, D Visent... [More Details]
Study results article	Yes		Loudon A, AD Williams and T Barnett. Yoga, Breast ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	The effect of yoga on women with secondary arm lymphoedema from breast cancer treatment	2012	https://doi.org/10.1186/1472-6882-12-66
Embase	The effects of yoga on shoulder and spinal actions for women with breast cancer-related lymphoedema of the arm: A randomised controlled pilot study.	2016	https://dx.doi.org/10.1186/s12906-016-1330-7

N.B. These documents automatically identified may not have been verified by the study sponsor.