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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]

nil

Universal Trial Number (UTN)

nil

Trial acronym

Linked study record

Health condition

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

Breast Cancer

Radiotherapy

Condition category

Condition code

Cancer

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]

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]

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]

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]

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]

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]

Functional performance (repeated chair rise, 400m walk and stair climb)

Timepoint [2]

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]

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]

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?

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]

Kenya

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Edith Cowan University

Address [1]

100 Joondalup Drive
Perth Western Australia
6027

Country [1]

Australia

Primary sponsor type

University

Name

Edith Cowan University

Address

100 Joondalup Drive
Perth Western Australia
6027

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Zoe Gibbs

Address [1]

P.O.Box 15377,00509
Nairobi

Country [1]

Kenya

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Edith Cowan University HREC

Ethics committee address [1]

100 Joondalup Drive
Perth
Western Australia 6027

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/03/2009

Approval date [1]

22/05/2009

Ethics approval number [1]

3698

Summary

Brief summary

Purpose
To compare changes in fatigue, muscle strength and physical function through prescription of either immediate exercise commenced during radiotherapy (DRT) to delayed exercise post-radiotherapy (PRT) in a randomised controlled trial  in breast cancer survivors in Kenya.  

Patients and Methods
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 (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 a 3-month follow-up (T3). UC undertook measures at baseline (T1) week-12 (T2) and at 3-months (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. 

Results
At 12-weeks exercise groups had superior outcomes in general fatigue compared to UC (DRT -17.2 %, p=.042; PRT -14.4%, p=.031). Both DRT and PRT groups maintained their superiority over UC care at the 3-month follow-up (DRT -10.8%, p=.012; PRT -9.2%, p=.031). At 12-weeks change in physical fatigue was superior for both DRT and PRT groups over UC (DRT -18.7%, p=.034; PRT-13.0%, p=.038), and DRT experienced lower physical fatigue levels that PRT (-5.5%, p=.045).  Both DRT and PRT groups maintained their superiority over UC at the 3-month follow-up (DRT -11.1%, p=.032; PRT -10.3%, p=.035). 1-RM chest press and seated row strength changes were superior for DRT and PRT compared to UC (chest press DRT +6.5Kg, p.001; PRT +5.3Kg, p=.002) (seated row DRT +7.3Kg, p=.002; PRT +4.4Kg, p=.001) at T2. At 3-months follow up superiority was seen for DRT exercise over UC for both chest press and seated row 1-RM strength (chest press +2.3Kg, p=.002; seated row +1.5Kg, p=.045). DRT was also superior over PRT for chest press (+3.2Kg, p=.026), and seated row (+3.5Kg, p=.002) at 3-months. 1-RM leg extension strength increased to a greater extent in the DRT group over UC at both 12-weeks (+5.8Kg, p=.006) and 3-months (+1.4, p=.042), but was not significantly different from PRT. Muscle endurance (70% 1-RM) for both chest press and leg extension was significantly enhanced in both DRT and PRT groups following 12-weeks in DRT and PRT compared to UC (chest press DRT +6.3rep, p=.011; PRT +4.5rep, p=.025; leg extension DRT +7.1rep, p=.022; PRT +6.9rep, p=.021), with no significant differences between DRT and PRT.  At the 3-month follow-up assessment only DRT was superior to UC for chest press (+2.9rep, p=.038) and leg extension (+3.9, p=.032). At T2, there was a significant difference favouring greater improvement in global health (+23.5%, p=.006); physical functioning (+12.0%, p=.010); role functioning (+13.3%, p=.010) and emotional functioning (+20.1%, p=.002) in DRT survivors compared to UC, but no differences between DRT and PRT groups. There were no significant group differences at the 3-month follow-up for any of the function scales. 

Conclusion
Our combined aerobic and resistance training prescribed during- or post-treatment for radiotherapy for breast cancer improves the muscle strength and functional performance, reduces fatigue and improves overall quality of life in breast cancer survivors  A tendency exists for greater improvement and maintenance of these endpoints with pre-habilitative exercise during-treatment.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Zoe Gibbs

Address

P.O. Box 15377, 00509
Nairobi

Country

Kenya

Phone

+254 721969640

Fax

zoe.gibbs@gmail.com

Contact person for scientific queries

Name

Zoe Gibbs

Address

P.O. Box 15377, 00509
Nairobi

Country

Kenya

Phone

+254 721969640

Fax

zoe.gibbs@gmail.com

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