ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12612000771853

Ethics application status

Approved

Date submitted

16/07/2012

Date registered

19/07/2012

Date last updated

19/07/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

Reduction of breast lymphoedema symptoms secondary to breast cancer: Phase I/II randomised controlled trial

Scientific title

In women with breast lymphoedema secondary to breast cancer, does breast swelling and symptoms decrease with exercise compared to no exercise?

Secondary ID [1]

NHMRC Application No: 1021608

Universal Trial Number (UTN)

Trial acronym

BEET (Breast Edema Exercise Trial)

Linked study record

Health condition

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

Breast swelling secondary to treatment of breast cancer

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Cancer

Breast

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Exercise programme - exercise training will run for 12 weeks, 3 x per week for approx 1 hr each session. Exercise sessions are indivual-based; while the exercise program is standardised, the intensity will be based on the woman's fitness level.

A trainer will meet women at their local community gym 3 x per week for the first 2 weeks then reducing to once a week for the rest of the program. The program will consist of 5 min warm-up, 20 min moderate - vigorous intensity aerobic exercise and 30 mins resistance exercise in the limbs and trunk using free weights and resistance equipment, and 5 min cool down.

Participants will be contacted on a weekly basis via phone calls by the study coodinator to check on their progress and that they are adhering to the exercise protocol 3 x a week, to maintain motivation and record the use of resources, and to monitor for any changes in their lymphoedema status.

Additionally, a semi-quantitative food frequency questionnaire will be emailed to participants on a monthly basis to assess their dietary intakes.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Control group will receive no exercise program during the 12 week intervention period.

However, they will still be contacted on a weekly basis by the study coordinator to monitor if they experience any changes in their lymphoedema and to record the use of resources during the trial period.

Additionally, a semi-quantitative food frequency questionnaire will be emailed to participants on a monthly basis to assess their dietary intakes.

Control group

Active

Outcomes

Primary outcome [1]

Lymphoedema status: Bioimpedance spectroscopy

Timepoint [1]

Baseline, 3 months

Primary outcome [2]

Breast ultrasound measurements

Timepoint [2]

Baseline, 3 months

Primary outcome [3]

Breast Volume measurements derived from measures taken with a tape measure (Kovacs et al, Breast. 2007 16(2):137-45.

Timepoint [3]

Baseline, 3 months

Secondary outcome [1]

Lymphoedema Symptom Intensity and Distress Survey-Arm and Trunk (LSIDS-AT)

Timepoint [1]

Baseline, 3 months

Secondary outcome [2]

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3 (QLQ-C30) and Breast module (BR23)

Timepoint [2]

Baseline, 3 months

Secondary outcome [3]

Maximal upper and lower limb muscle strength will be assessed with by a 1-RM test using an isokinetic dynamometer.

Timepoint [3]

Baseline, 3 months

Secondary outcome [4]

YMCA cycle ergotemtry test

Timepoint [4]

Baseline, 3 months

Eligibility

Key inclusion criteria

Stage I-III breast cancer and treated with wide local excision and axillary surgery for their breast cancer; have developed unilateral breast lymphoedema ; have had stable lymphoedema for at least 3 months; and
are sedentary.

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Have had surgery for their breast cancer within the last 3 months; currently having active treatment for cancer; have a history of bilateral lymph node dissection; have a history of primary lymphoedema ; have had intensive therapy for their lymphoedema within the last 3 months; have had an infection requiring antibiotic treatment in the lymphoedematous region within the last 3 months; are unable to elevate their upper limbs by > 120 degrees minimum; have musculoskeletal or neurological conditions that would affect exercise training and/or assessments; and have any medical conditions (including surgeries) that could prevent participation in exercise.

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)

We will use a number of strategies to recruit women into the study, including i) invitations to women in our database of women who have previously participated in our research studies; ii) recruitment advertisements bi-annually in metropolitan newspapers and newsletters of various consumer organisations, such as BCNA, Lymphoedema Group; iii) National Breast Cancer Foundation Register4. A person not involved with the project will prepare sequentially numbered opaque envelopes with the group allocation sealed inside.

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

The randomisation list will be computer generated in permuted blocks.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

2/07/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

103

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

Faculty of Health Sciences
75 East St (PO Box 170)
Lidcombe NSW 1825

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Ethics Committee

Ethics committee address [1]

Level 3, Room 313
A22- Old Teacher's College 
University of Sydney
Camperdown, NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

18/10/2011

Ethics approval number [1]

10-2011 / 14037

Summary

Brief summary

This study aims to investigate whether an exercise program reduces swelling in women with breast lymphoedema symptoms secondary to breast ca ncer.

Who is it for? 
You may be eligible to join this study if you are a female aged 18 years or above who has stage I-III breast cancer which has been surgically treated. You should have had stable breast lymphoedema for at least 3 months and be sedentary.

Trial details
Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will participate in an exercise program that consists of 3 x 1 hour training sessions per week for 12 weeks. A trainer will meet women in this group at their local community gym 3 x per week for the first 2 weeks then reducing to once a week for the rest of the program. The program will consist of a 5 min warm-up, followed by 20 min of moderate to vigorous intensity aerobic exercise and 30 min resistance exercise in the limbs and trunk using free weights and resistance equipment, and finishing with a 5 min cool down. Participants in the second group will receive no exercise p rogram. 

Participants in both groups will be contacted by the study coordinator on a weekly basis to monitor their progress. Participants will also undergo clinical assessment at baseline and 3 months, and be asked to complete questionnaires about their symptoms, quality of life and dietary intake.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Ms Lanni Lin

Address

University of Sydney
Faculty of Health Sciences
75 East St (PO BOX 170)
Lidcombe, NSW 1825

Country

Australia

Phone

61 2 9036 7309

Fax

61 2 9351 9601

llin@sydney.edu.au

Contact person for scientific queries

Name

Prof Sharon Kilbreath

Address

University of Sydney
Faculty of Health Sciences
75 East St (PO BOX 170)
Lidcombe NSW 1825

Country

Australia

Phone

61 2 9036 7309

Fax

61 2 9351 9601

sharon.kilbreath@sydney.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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Bioimpedance Spectroscopy of the Breast.	2020	https://dx.doi.org/10.1089/lrb.2019.0087
Embase	Reduction of breast lymphoedema secondary to breast cancer: a randomised controlled exercise trial.	2020	https://dx.doi.org/10.1007/s10549-020-05863-4
Embase	Ultrasound: Assessment of breast dermal thickness: Reliability, responsiveness to change, and relationship to patient-reported outcomes.	2022	https://dx.doi.org/10.1111/srt.13100

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

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically