Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000646842
Ethics application status
Approved
Date submitted
14/06/2012
Date registered
19/06/2012
Date last updated
19/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fatigue, and changes to muscle strength and physical function in delayed versus immediate exercise for breast cancer survivors scheduled for radiation therapy: A randomised controlled trial
Scientific title
Fatigue, and changes to muscle strength and physical function in delayed versus immediate exercise for breast cancer survivors scheduled for radiation therapy: A randomised controlled trial
Secondary ID [1] 280673 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 286695 0
Radiotherapy 286696 0
Condition category
Condition code
Cancer 286993 286993 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 – Resistance Training during radiation therapy
Arm 2 – Resistance Training post radiotherapy
Arm 3 – Usual Care (Control)


Sixty-seven breast cancer survivors scheduled to undertake radiotherapy were screened for participation from November 2009 to December 2010 and randomised (n=63) to three arms: during treatment exercise (DRT n=20); post treatment exercise (PRT n=22) and usual care (UC n=21). Outcomes for fatigue (Multi-dimensional fatigue inventory (MFI); muscle strength (1-RM); muscle endurance (70% 1-RM); functional performance (chair-rise, stair climb, 400-m walk) and quality of life (EORTC-C30 BR-23) were assessed at baseline (Time 1: T1), 12-weeks (Time 2: T2) and 3-month follow-up post intervention (Time 3: T3). All subjects were assessed at T1. Subjects were then either randomly allocated to exercise during radiation (DRT) (6-weeks); wait for the 6 weeks of radiation to be completed to initiate the exercise (PRT) (further 6-weeks) or did not receive any exercise intervention - usual care (UC). Both DRT and PRT were then compared at week 12 (T2). Both DRT and PRT were then also assessed at the 3-month follow-up (T3). UC undertook measures at baseline (T1) week-12 (T2) and at the 3-month follow-up (T3). Survivors were irradiated with a total dose of 50Gy with a dose per fraction of 2Gy for 25 treatments. Some women received an additional 10Gy to the original tumour bed in 5 fractions.

Exercise training intervention
Participants undertook combined aerobic and progressive resistance training twice a week for 6-weeks in a supervised clinical exercise facility. Each session lasted 50 mins. 5 minutes warm-up and cool-down were performed before and after the session and included light aerobic activity and stretching. The resistance exercises included the chest press, seated row, and lateral pull down, lateral raises, front raises, triceps extension, leg extension and abdominal crunches. The resistance exercise program was designed to progress from 12- to 6-repetition maximum (RM) for two to four sets per exercise. The aerobic component of the training program included 15 minutes of cardiovascular exercises per session (walking/cycling/jogging) at 65% to 80% maximum heart rate and at a perceived exertion ranging from 11 to 13 (6 to 20 point Borg Scale).
Intervention code [1] 285079 0
Rehabilitation
Comparator / control treatment
No treatment/exercise but rather continuation of normal daily activities and lifestyle – usual care
Control group
Active

Outcomes
Primary outcome [1] 287331 0
Fatigue (Multi-dimensional fatigue inventory assessed at baseline (Time 1: T1), at 12-weeks (Time 2: T2) and at a 3-month follow-up (Time 3: T3).
Timepoint [1] 287331 0
Assessed at baseline (Time 1: T1),
at 12-weeks (Time 2: T2)
and at a 3-month follow-up (Time 3: T3)
Secondary outcome [1] 297918 0
1-RM Strength
Dynamic concentric muscle strength was measured for three exercises (Chest Press, Seated Row and
Leg Extension), using the one repetition maximum (1-RM).The 1-RM being the maximal weight an individual can move through a full
range of motion without a change in body position other than that dictated by the specific exercise
motion
Timepoint [1] 297918 0
Assessed at baseline (Time 1: T1),
at 12-weeks (Time 2: T2)
and at a 3-month follow-up (Time 3: T3)
Secondary outcome [2] 297919 0
Functional performance (repeated chair rise, 400m walk and stair climb)
Timepoint [2] 297919 0
Assessed at baseline (Time 1: T1),
at 12-weeks (Time 2: T2)
and at a 3-month follow-up (Time 3: T3)
Secondary outcome [3] 297920 0
Cancer Specific Quality of Life using the European Organisation for Research and Treatment in Cancer (EORTC) Quality of Life Questionaire (QLQ-C30) with the breast cancer Specific Module (BR-23)
Timepoint [3] 297920 0
Assessed at baseline (Time 1: T1),
at 12-weeks (Time 2: T2)
and at a 3-month follow-up (Time 3: T3)

Eligibility
Key inclusion criteria
Inclusion was for women with a history of unilateral breast cancer, who were scheduled for radiotherapy and had not participated in any prior structured exercise training in the past three-months
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion was for those patients with any musculoskeletal, cardiovascular, neurological or psychiatric condition that could be exacerbated by exercise participation, inhibit their exercise response, or otherwise not approved by their oncologist. Women were not excluded based on fitness levels or body mass index nor were they excluded if they are undertaking other adjuvant therapies such as chemo- or hormone therapy, however this was noted.

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)
Following completion of baseline assessments, allocation concealment was done by central randomisation by computer Following familiarisation and baseline assessments patients were randomly assigned to three arms DRT, during-radiotherapy exercise; PRT, Post-radiotherapy exercise or UC, usual care in a 1:1:1 ratio in a 1:1:1 ratio using a computer generated program stratified by age (<50 years or >50 years) and stage of disease (stages 0-I or stages II-III). Allocation sequence was concealed from the exercise physiologist involved in assigning patients to groups. UC were asked to maintain their normal habitual activities, not to commence an exercise program and were offered a similar 6-week training program following completion of the assessment period.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Completed
Date of first participant enrolment
Anticipated
23/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4363 0
Kenya
State/province [1] 4363 0

Funding & Sponsors
Funding source category [1] 285438 0
University
Name [1] 285438 0
Edith Cowan University
Country [1] 285438 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
100 Joondalup Drive
Perth Western Australia
6027
Country
Australia
Secondary sponsor category [1] 284289 0
Individual
Name [1] 284289 0
Zoe Gibbs
Address [1] 284289 0
P.O.Box 15377,00509
Nairobi
Country [1] 284289 0
Kenya

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287449 0
Edith Cowan University HREC
Ethics committee address [1] 287449 0
Ethics committee country [1] 287449 0
Australia
Date submitted for ethics approval [1] 287449 0
15/03/2009
Approval date [1] 287449 0
22/05/2009
Ethics approval number [1] 287449 0
3698

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34311 0
Address 34311 0
Country 34311 0
Phone 34311 0
Fax 34311 0
Email 34311 0
Contact person for public queries
Name 17558 0
Zoe Gibbs
Address 17558 0
P.O. Box 15377, 00509
Nairobi
Country 17558 0
Kenya
Phone 17558 0
+254 721969640
Fax 17558 0
Email 17558 0
[email protected]
Contact person for scientific queries
Name 8486 0
Zoe Gibbs
Address 8486 0
P.O. Box 15377, 00509
Nairobi
Country 8486 0
Kenya
Phone 8486 0
+254 721969640
Fax 8486 0
Email 8486 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
No additional documents have been identified.