ANZCTR - Registration

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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

Condition category

Condition code

Cancer

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]

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]

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]

At baseline, 8 weeks (at the end of intervention) and 6 months intervals up to 3 years after the surgery

Secondary outcome [1]

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]

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]

2. Passive forward flexion, extermal rotation, horizontal abduction and active abduction at the shoulder will be assessed.

Timepoint [2]

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]

3. Maximal isometric shoulder strength of forward flexion, abduction, and horizontal abduction and adduction will be measured objectively using a standardised protocol.

Timepoint [3]

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]

4. Pain at the end of passive range of each movement will be measured using a standardised 10 cm visual analogue scale.

Timepoint [4]

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]

5. Multiple frequency bio-impedanced analysis (MFBIA) will be used to identify early changes in tissue density, and in particular, extracellular fluid.

Timepoint [5]

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]

6. Limb circumference measures of each arm will be determined using a standardised measurement technique.

Timepoint [6]

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]

Charities/Societies/Foundations

Name [1]

Cancer Council NSW

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Sydney

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney human ethics committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Royal Prince Alfred Hospital human ethics committee

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

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

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Sharon Kilbreath

Address

School of Physiotherapy
Faculty of Health Sciences
University of Sydney
C42
PO Box 170
Lidcombe NSW 1825

Country

Australia

Phone

+61 2 93519272

Fax

+61 2 93519160

Email

[email protected]

Contact person for scientific queries

Name

Sharon Kilbreath

Address

School of Physiotherapy
Faculty of Health Sciences
University of Sydney
C42
PO Box 170
Lidcombe NSW 1825

Country

Australia

Phone

+61 2 93519272

Fax

+61 2 93519160

Email

[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

No additional documents have been identified.