Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001094965
Ethics application status
Approved
Date submitted
20/10/2011
Date registered
20/10/2011
Date last updated
21/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Whole-Body Vibration Treatment in Breast Cancer Survivors on Aromatase Inhibitor Therapy
Scientific title
The Effect of Whole-Body Vibration Treatment on Bone Metabolism in Breast Cancer Survivors who are undergoing Aromatase Inhibitor Therapy
Secondary ID [1] 273159 0
Nil
Universal Trial Number (UTN)
U1111-1125-0162
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 278913 0
Osteopenia 278914 0
Condition category
Condition code
Cancer 279090 279090 0 0
Breast
Musculoskeletal 279091 279091 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Whole body vibration therapy (using a vibration device), 20 minutes, three times per week for 12 weeks. Vibration will be at 32-37Hz, 0.85mm peak-to-peak displacement, and at a magnitude of 0.3g.
Intervention code [1] 269493 0
Treatment: Devices
Intervention code [2] 269581 0
Prevention
Comparator / control treatment
No treatment
The control group will be offered the intervention after completion of the 12 week trial.
Control group
Active

Outcomes
Primary outcome [1] 279824 0
Marker of bone formation - Serum Type 1 Procollagen N-terminal Propeptide (P1NP)
Timepoint [1] 279824 0
Baseline and after 12-weeks of intervention
Primary outcome [2] 279825 0
Marker of bone resorption - Urine analysis of N-telopeptide X/Creatinine (NTx/Cr)
Timepoint [2] 279825 0
Baseline and after 12-weeks of intervention
Secondary outcome [1] 294518 0
Fatigue - FACIT Fatigue Scale
Timepoint [1] 294518 0
Baseline and after 12-weeks of intervention
Secondary outcome [2] 294519 0
Physical Activity Levels - Godin Questionnaire
Timepoint [2] 294519 0
Baseline and after 12-weeks of intervention
Secondary outcome [3] 294520 0
Pain - WOMAC Scale and a Visual Analogue Scale
Timepoint [3] 294520 0
Baseline and after 12-weeks of intervention
Secondary outcome [4] 294521 0
Upper and Lower Body Strength - 1 Repetition Maximum assessment of chest press and leg press
Timepoint [4] 294521 0
Baseline and after 12-weeks of intervention
Secondary outcome [5] 294522 0
Physical Function - Standard measures of chair standing, six-minute walk, static balance
Timepoint [5] 294522 0
Baseline and after 12-weeks of intervention
Secondary outcome [6] 294523 0
Body Composition - Dual-energy X-ray absorptiometry
Timepoint [6] 294523 0
Baseline and after 12-weeks of intervention

Eligibility
Key inclusion criteria
Currently taking an Aromatase Inhibitor drug for the treatment of breast cancer;
Willing to continue taking any bone altering medications or supplements they were previously taking for the duration of the study, including calcium and vitamin D;
Able to stand unassisted for sustained periods of time (i.e. 20 minutes)
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently taking bisphosphonate medication;
Cognitive impairment;
Contraindications to vibration platform training (including pacemaker and fracture within the past six months);
Diagnosis of bone metastasis, and
Diagnosis of diseases other than osteoporosis affecting bone

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)
Written informed consent will be required prior to any testing or randomisation. Assignments will be placed in sealed opaque envelopes and designated colours will be assigned for each group. The subject will open these envelopes after completion of all baseline testing. Subjects who dropout prior to completion of baseline testing will not be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects are randomised after the baseline assessment has been completed to: 1. Vibration training or 2. Wait-list control. Randomisation is at the level of the individual patient, and will be stratified by age, currently taking calcium or vitamin D, current exercise status. The list will be generated and maintained by a research assistant not otherwise involved in the study. The sequential treatment assignments are based on a computer-generated randomisation scheme (by using the Web site www.randomization.com set up by Dr Gerard E. Dallal).
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
Recruiting
Date of first participant enrolment
Anticipated
16/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 270072 0
Charities/Societies/Foundations
Name [1] 270072 0
Cancer Council Western Australia
Country [1] 270072 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Baker
Address
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 269038 0
None
Name [1] 269038 0
Address [1] 269038 0
Country [1] 269038 0
Other collaborator category [1] 252307 0
Individual
Name [1] 252307 0
A/Prof Daniel Galvao
Address [1] 252307 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country [1] 252307 0
Australia
Other collaborator category [2] 252308 0
Individual
Name [2] 252308 0
Prof Robert Newton
Address [2] 252308 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country [2] 252308 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272027 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 272027 0
270 Joondalup Drive
Joondalup WA 6027
Ethics committee country [1] 272027 0
Australia
Date submitted for ethics approval [1] 272027 0
04/10/2011
Approval date [1] 272027 0
22/11/2011
Ethics approval number [1] 272027 0
7426 BAKER

Summary
Brief summary
This study aims to examine the effect of vibration therapy on markers of bone turnover in breast cancer patients on aromatase inhibitors.

Who is it for?
You may be eligible to join this study if you are a woman of any age who is currently taking an Aromatase Inhibitor drug for the treatment of breast cancer.

Trial details.
Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will undergo whole body vibration therapy. This involves standing on a gently vibrating platform for 20 minutes, three times per week over a period of 12 weeks. The other group will be assigned to no treatment for the 12 week trial period. After this time participants in this group will be offered the vibration treatment.

Participants will give blood and urine samples at baseline and at 12 weeks to examine markers of bone metabolism. They will also complete some tests of physical function and questionnaires about fatigue, pain and physical activity levels at these time points. It is thought that vibration training will decrease the breakdown of bone compared to no training.
Trial website
http://www.ecuhealthwellnessinstitute.org/research-activity/projects
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33233 0
Address 33233 0
Country 33233 0
Phone 33233 0
Fax 33233 0
Email 33233 0
Contact person for public queries
Name 16480 0
Dr Michael Baker
Address 16480 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country 16480 0
Australia
Phone 16480 0
+61 8 6304 3431
Fax 16480 0
Email 16480 0
[email protected]
Contact person for scientific queries
Name 7408 0
Dr Michael Baker
Address 7408 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country 7408 0
Australia
Phone 7408 0
+61 8 6304 3431
Fax 7408 0
Email 7408 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
SourceTitleYear of PublicationDOI
EmbaseWhole Body Vibration Exposure on Markers of Bone Turnover, Body Composition, and Physical Functioning in Breast Cancer Patients Receiving Aromatase Inhibitor Therapy: A Randomized Controlled Trial.2018https://dx.doi.org/10.1177/1534735418781489
N.B. These documents automatically identified may not have been verified by the study sponsor.