Trial Review

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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] 273505 0
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 279303 0
Condition category
Condition code
Physical Medicine / Rehabilitation 279497 279497 0 0
Physiotherapy
Cancer 287251 287251 0 0
Breast
Cardiovascular 287252 287252 0 0
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] 283821 0
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] 286058 0
Lymphoedema status: Bioimpedance spectroscopy
Timepoint [1] 286058 0
Baseline, 3 months
Primary outcome [2] 286059 0
Breast ultrasound measurements
Timepoint [2] 286059 0
Baseline, 3 months
Primary outcome [3] 286060 0
Breast Volume measurements derived from measures taken with a tape measure (Kovacs et al, Breast. 2007 16(2):137-45.
Timepoint [3] 286060 0
Baseline, 3 months
Secondary outcome [1] 295067 0
Lymphoedema Symptom Intensity and Distress Survey-Arm and Trunk (LSIDS-AT)
Timepoint [1] 295067 0
Baseline, 3 months
Secondary outcome [2] 295068 0
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3 (QLQ-C30) and Breast module (BR23)
Timepoint [2] 295068 0
Baseline, 3 months
Secondary outcome [3] 298342 0
Maximal upper and lower limb muscle strength will be assessed with by a 1-RM test using an isokinetic dynamometer.
Timepoint [3] 298342 0
Baseline, 3 months
Secondary outcome [4] 298343 0
YMCA cycle ergotemtry test
Timepoint [4] 298343 0
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?
No
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] 284304 0
Government body
Name [1] 284304 0
National Health and Medical Research Council
Country [1] 284304 0
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] 283250 0
None
Name [1] 283250 0
Address [1] 283250 0
Country [1] 283250 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286266 0
University of Sydney Ethics Committee
Ethics committee address [1] 286266 0
Level 3, Room 313
A22- Old Teacher's College
University of Sydney
Camperdown, NSW 2006
Ethics committee country [1] 286266 0
Australia
Date submitted for ethics approval [1] 286266 0
Approval date [1] 286266 0
18/10/2011
Ethics approval number [1] 286266 0
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 33468 0
Address 33468 0
Country 33468 0
Phone 33468 0
Fax 33468 0
Email 33468 0
Contact person for public queries
Name 16715 0
Ms Lanni Lin
Address 16715 0
University of Sydney
Faculty of Health Sciences
75 East St (PO BOX 170)
Lidcombe, NSW 1825
Country 16715 0
Australia
Phone 16715 0
61 2 9036 7309
Fax 16715 0
61 2 9351 9601
Email 16715 0
[email protected]
Contact person for scientific queries
Name 7643 0
Prof Sharon Kilbreath
Address 7643 0
University of Sydney
Faculty of Health Sciences
75 East St (PO BOX 170)
Lidcombe NSW 1825
Country 7643 0
Australia
Phone 7643 0
61 2 9036 7309
Fax 7643 0
61 2 9351 9601
Email 7643 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseBioimpedance Spectroscopy of the Breast.2020https://dx.doi.org/10.1089/lrb.2019.0087
EmbaseReduction of breast lymphoedema secondary to breast cancer: a randomised controlled exercise trial.2020https://dx.doi.org/10.1007/s10549-020-05863-4
EmbaseUltrasound: Assessment of breast dermal thickness: Reliability, responsiveness to change, and relationship to patient-reported outcomes.2022https://dx.doi.org/10.1111/srt.13100
N.B. These documents automatically identified may not have been verified by the study sponsor.