ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

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]

nil

Universal Trial Number (UTN)

U1111-1129-4701

Trial acronym

Linked study record

Health condition

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

breast cancer

Condition category

Condition code

Cancer

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]

Rehabilitation

Comparator / control treatment

Control group receives no treatment

Control group

Active

Outcomes

Primary outcome [1]

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]

Week 0 and Week 17

Secondary outcome [1]

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]

Week 0, Week 8, Week 17

Secondary outcome [2]

Additional immune and inflammatory parameters: Full blood count, IL-6, lymphocyte proliferation, and lymphocyte subsets, CRP levels, blood lipids

Timepoint [2]

Week 0 and Week 17

Secondary outcome [3]

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]

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

Sex

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

1/05/2012

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]

University

Name [1]

University of Western Sydney

Address [1]

Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751

Country [1]

Australia

Primary sponsor type

Individual

Name

Amanda McKee

Address

4/57 Jacaranda Avenue
Bradbury
NSW
2560

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Bobby Cheema

Address [1]

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]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UWS HUMAN RESEARCH ETHICS COMMITTEE

Ethics committee address [1]

Office of Research Services
Building K, Penrith Campus
University of Western Sydney
Locked Bag 1797
Penrith, 2751
NSW, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/03/2012

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Amanda McKee

Address

Amanda McKee
Sport and Exercise Science
School of Science and Health
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW 1797

Country

Australia

Phone

+61 414890342

Fax

M.Mckee@uws.edu.au

Contact person for scientific queries

Name

Amanda McKee

Address

Amanda McKee
Sport and Exercise Science
School of Science and Health
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW 1797

Country

Australia

Phone

+61 414890342

Fax

M.Mckee@uws.edu.au

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

Source	Title	Year of Publication	DOI
Embase	The effect of resistance training on markers of immune function and inflammation in previously sedentary women recovering from breast cancer: a randomized controlled trial.	2016	https://dx.doi.org/10.1007/s10549-016-3688-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically