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Trial registered on ANZCTR


Trial ID
ACTRN12612000346875
Ethics application status
Approved
Date submitted
26/03/2012
Date registered
26/03/2012
Date last updated
26/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of resistance training on natural killer cell activity in women recovering from breast cancer treatment: A randomised controlled trial
Scientific title
Effect of resistance training on natural killer cell activity in women recovering from breast cancer treatment: A randomised controlled trial
Secondary ID [1] 280215 0
nil
Universal Trial Number (UTN)
U1111-1129-4701
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 286151 0
Condition category
Condition code
Cancer 286348 286348 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Resistance exercise intervention: 16 week resistance training intervention conducted 3 times per week for approximately 1 hour per session encompassing full body weight training. Progressive resistance training (free weights and machines) will be administered by a qualified trainer (BSc, MSc exercise rehabilitation) in a group situation. The head trainer will be assisted by 3rd year students.
Intervention code [1] 284544 0
Rehabilitation
Comparator / control treatment
Control group receives no treatment
Control group
Active

Outcomes
Primary outcome [1] 286810 0
Natural killer cell activity measured as percent lysis at multiple target to effector ratios. Blood will be collected twice at week 0 and twice at week 17 to establish a true resting norm (mean of the two collections) for this measure and the secondary immune and inflammatory markers. Blood will be taken by a certified phlebotomist. Blood will then be analysed in the University laboratory and commercial pathology laboratories.
Timepoint [1] 286810 0
Week 0 and Week 17
Secondary outcome [1] 296714 0
Muscular strength. Muscular strength will be assessed via isokinetic dynamometry on the kincom. Shoulder internal and external rotation and knee flexion and extension will be assessed. 3 trials will be implemented, with the highest measure recorded.
Timepoint [1] 296714 0
Week 0, Week 8, Week 17
Secondary outcome [2] 296715 0
Additional immune and inflammatory parameters: Full blood count, IL-6, lymphocyte proliferation, and lymphocyte subsets, CRP levels, blood lipids
Timepoint [2] 296715 0
Week 0 and Week 17
Secondary outcome [3] 296716 0
Quality of life: As assessed by the FACT-G (cancer general scale), FACIT-fatigue (cancer fatigue scale), and the SF-36 health questionnaire
Timepoint [3] 296716 0
Week 0 and Week 17

Eligibility
Key inclusion criteria
Histologically confirmed stage I to IIIA breast cancer with no evidence of recurrent disease; postmenopausal, age 40-70 years; diagnosed with breast cancer within the previous 2.5 years and completed surgery, radiotherapy and/or chemotherapy within the past 1.5 years, with or without current use of hormonal therapy (e.g. tamoxifen, aromatase inhibitors); sedentary (<30min of continuous moderate-intensity exercise, 3 times per week), absence of autoimmune systemic disease(s); with or without existing upper extremity lymphedema; stable underlying chronic diseases; ability to communicate in English; no acute or chronic medical conditions which would make resistance training potentially hazardous or primary outcomes impossible to assess; willingness and cognitive ability to provide written informed consent to participate in the trial.
Minimum age
40 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
failure to meet inclusion criteria

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)
Participants will be randomised via a computer-generated list (www.randomization.com) stratified by age (<50yr; >50yr) and current use of hormonal therapy (Yes; No). An investigator not involved in testing or the delivery of the intervention will prepare the randomization assignments. Group assignments will be delivered to participants in sealed envelopes upon the completion of baseline testing
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised via a computer-generated list (www.randomization.com)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284965 0
University
Name [1] 284965 0
University of Western Sydney
Address [1] 284965 0
Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country [1] 284965 0
Australia
Primary sponsor type
Individual
Name
Amanda McKee
Address
4/57 Jacaranda Avenue
Bradbury
NSW
2560
Country
Australia
Secondary sponsor category [1] 283833 0
Individual
Name [1] 283833 0
Dr Bobby Cheema
Address [1] 283833 0
Dr. Bobby Cheema
Senior Lecturer of Sport & Exercise Science
School of Science and Health
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW 1797
Country [1] 283833 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286972 0
UWS HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 286972 0
Office of Research Services
Building K, Penrith Campus
University of Western Sydney
Locked Bag 1797
Penrith, 2751
NSW, Australia
Ethics committee country [1] 286972 0
Australia
Date submitted for ethics approval [1] 286972 0
Approval date [1] 286972 0
23/03/2012
Ethics approval number [1] 286972 0
H9427

Summary
Brief summary
Breast cancer is the most commonly diagnosed invasive cancer in women. Breast cancer patients often suffer from suppressed immune functioning as a result of the cancer and its therapies. The aim of this project is to examine whether resistance exercise can enhance immune functioning in breast cancer survivors. Participants will undergo a testing protocol consisting of measurements of immune function (blood sample), strength and quality of life (questionnaires). Participants will then be randomly assigned to undertake a 16 week resistance training intervention or to continue on as normal in a control group. At the completion of the 16 weeks the participants will undergo the same tests as at baseline. These tests (strength and quality of life) will also be completed at a 6 month follow up. Who is it for? The study is open to postmenopausal women aged 40-70 years who are recovering from stage I to IIIA breast cancer and its associated treatment. Full details of the inclusion and exclusion criteria for this trial can be found in the relevant sections of this form. Trial details This study involves participating in a 16 week resistance exercise intervention, conducted 3 times per week in groups for approximately 1 hour per session encompassing full body weight training and progressive resistance training consisting of the use of free weights and machines, under the supervision of a qualified trainer who is assisted by 3rd year students.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33974 0
Address 33974 0
Country 33974 0
Phone 33974 0
Fax 33974 0
Email 33974 0
Contact person for public queries
Name 17221 0
Amanda McKee
Address 17221 0
Amanda McKee
Sport and Exercise Science
School of Science and Health
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW 1797
Country 17221 0
Australia
Phone 17221 0
+61 414890342
Fax 17221 0
Email 17221 0
M.Mckee@uws.edu.au
Contact person for scientific queries
Name 8149 0
Amanda McKee
Address 8149 0
Amanda McKee
Sport and Exercise Science
School of Science and Health
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW 1797
Country 8149 0
Australia
Phone 8149 0
+61 414890342
Fax 8149 0
Email 8149 0
M.Mckee@uws.edu.au