Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000050550
Ethics application status
Approved
Date submitted
3/02/2006
Date registered
6/02/2006
Date last updated
17/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physiotherapy following breast cancer surgery
Scientific title
Early strengthening and stretching exercises to improve arm mobility for women following breast cancer surgery: a randomised controlled study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women following breast cancer surgery 1012 0
Condition category
Condition code
Cancer 1088 1088 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise Group: Commencing week 4 following surgery, women will attend weekly physiotherapy sessions comprising stretching exercises, resistance training and functional tasks and commence a daily home program of similar exercises for 8 weeks.
Intervention code [1] 871 0
Rehabilitation
Comparator / control treatment
Usual care: women will receive the same care as is now given in three hospitals (Royal Prince Alfred, Concored General and Strathfield Private Hospitals). They will not be given a home program of exercises, apart from those described in a pamphlet provided to all patients. To control attention from the therapist, they will be telephoned at the same time intervals as women in the exercise group, but no specific advice will be given about exercise and management.
Control group
Active

Outcomes
Primary outcome [1] 1453 0
Arm symptoms on the operated side from 3 items of the Breast Module (BR 23). The BR23 is a 23 item survey specific to women with breast cancer.
Timepoint [1] 1453 0
At baseline, 8 weeks (at the end of intervention) and 6 months intervals up to 3 years after the surgery
Secondary outcome [1] 2603 0
1. Several aspects of quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3 (QLQ-C30).
Timepoint [1] 2603 0
Measured at baseline (4-5weeks after surgery), at 8 weeks (at the end of intervention), and 6 months intervals up to 3 years after surgery.
Secondary outcome [2] 2604 0
2. Passive forward flexion, extermal rotation, horizontal abduction and active abduction at the shoulder will be assessed.
Timepoint [2] 2604 0
Measured at baseline (4-5weeks after surgery), at 8 weeks (at the end of intervention), and 6 months intervals up to 3 years after surgery.
Secondary outcome [3] 2605 0
3. Maximal isometric shoulder strength of forward flexion, abduction, and horizontal abduction and adduction will be measured objectively using a standardised protocol.
Timepoint [3] 2605 0
Measured at baseline (4-5weeks after surgery), at 8 weeks (at the end of intervention), and 6 months intervals up to 3 years after surgery.
Secondary outcome [4] 2606 0
4. Pain at the end of passive range of each movement will be measured using a standardised 10 cm visual analogue scale.
Timepoint [4] 2606 0
Measured at baseline (4-5weeks after surgery), at 8 weeks (at the end of intervention), and 6 months intervals up to 3 years after surgery.
Secondary outcome [5] 2607 0
5. Multiple frequency bio-impedanced analysis (MFBIA) will be used to identify early changes in tissue density, and in particular, extracellular fluid.
Timepoint [5] 2607 0
Measured at baseline (4-5weeks after surgery), at 8 weeks (at the end of intervention), and 6 months intervals up to 3 years after surgery.
Secondary outcome [6] 2608 0
6. Limb circumference measures of each arm will be determined using a standardised measurement technique.
Timepoint [6] 2608 0
Measured at baseline (4-5weeks after surgery), at 8 weeks (at the end of intervention), and 6 months intervals up to 3 years after surgery.

Eligibility
Key inclusion criteria
If they have breast cancer intervention that included surgery to the axilla.* they can attend for treatment and follow-up, and* they understand English and consent to participate and be randomised to either treatment group.Women will be excluded if they have:* not had surgery to the axilla,* undergone bilateral operations,* received previous treatment for breast cancer, or metastatic disease, * sustained a fracture, undergone surgery in the upper limbs or suffer any neurological deficit or other injury to either upper limb that may intefere with the test procedures, or* undergone breast reconstruction and whom their specialist has indicated that they are not to participate.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random allocation stratified by whether the woman received axillary node resection or sentinel node biopsy
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1192 0
Charities/Societies/Foundations
Name [1] 1192 0
Cancer Council NSW
Country [1] 1192 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 1053 0
University
Name [1] 1053 0
University of Sydney
Address [1] 1053 0
Country [1] 1053 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2511 0
University of Sydney human ethics committee
Ethics committee address [1] 2511 0
Ethics committee country [1] 2511 0
Australia
Date submitted for ethics approval [1] 2511 0
Approval date [1] 2511 0
Ethics approval number [1] 2511 0
Ethics committee name [2] 2512 0
Royal Prince Alfred Hospital human ethics committee
Ethics committee address [2] 2512 0
Ethics committee country [2] 2512 0
Australia
Date submitted for ethics approval [2] 2512 0
Approval date [2] 2512 0
Ethics approval number [2] 2512 0

Summary
Brief summary
Breast cancer affects nearly 10,000 Australian women each year. Because the treatment of the cancer is so invasive and aggressive, and there is insufficient rehabilitation, women often report the presence of symptoms such as stiffness, weakness, swelling and pain months and years after treatment. These symptoms can impact on the quality of life and interfere substantially with activities of daily living for the cancer survivor. We will investigate whether an early intervention program of daily stretching and strengthening for muscles about the shoulder prevents occurence of these symptoms. We will compare the outcomes of patients randomly assigned to either an exercise group or a usual care (control) group. Subjects allocated to the exercise group will perform exercises daily, and will be supervised by a physiotherapist once a week for 8 weeks. At the end of the 8 weeks, subjects will be given a home-based training program to continue indefinitely. Subjects in the 'Usual care' group will receive the same care as is now typically received, a vist by the physiotherapist and occupational therapist while an inpatient, and receipt of pamphlets. All subjects will be measured at baseline, 8 weeks, and 6 months intervals up to 3 years. The primary measure is arm symptoms, derived from a Breast Cancer specific questionnaire (BR32). In addition, range of motion, strength, swelling, pain and quality of life will be assessed. This study will determine whether the secondary problmes associated with treatment of breast cancer can be prevented by exercise, and provide the basis for successful rehabilitation. Additionally, it will identify whether strengthening exercises reduces the incidence of swelling.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36126 0
Address 36126 0
Country 36126 0
Phone 36126 0
Fax 36126 0
Email 36126 0
Contact person for public queries
Name 10060 0
Sharon Kilbreath
Address 10060 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
C42
PO Box 170
Lidcombe NSW 1825
Country 10060 0
Australia
Phone 10060 0
+61 2 93519272
Fax 10060 0
+61 2 93519160
Email 10060 0
[email protected]
Contact person for scientific queries
Name 988 0
Sharon Kilbreath
Address 988 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
C42
PO Box 170
Lidcombe NSW 1825
Country 988 0
Australia
Phone 988 0
+61 2 93519272
Fax 988 0
+61 2 93519160
Email 988 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
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