Breast NeoplasmsBETANCT01435005
Breast Cancer and Exercise Trial in Alberta
A study testing Moderate Volume and High Volume in people with Breast Neoplasms, run by AHS Cancer Control Alberta at 2 sites in Canada.
Trial summary
The Breast Cancer and Exercise Trial (BETA Trial) is a randomized controlled trial aimed at understanding what dose (or volume) of exercise will best reduce the risk for breast cancer, particularly among women who are between the ages of 50-74. Read more about this study
- Who is it for?
- Ages 50 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Moderate Volume and High Volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 50- 74 years, postmenopausal women
- No previous cancer diagnosis
- Physically fit to undertake exercise program
- Pass the Physical Activity Readiness
- Medical Exam,acceptable heart and lung function during a sub-maximal treadmill test
- Body mass index : 22 - 40
Show all 9Show fewer
- Non-users of exogenous hormones or drugs related to estrogen metabolism, breast tissue growth
- Non-Smoker and non-excessive alcohol drinkers
- Residents of Calgary and Edmonton able to attend fitness facility regularly.
Who cannot join
- < 50 years of age
- Diabetes
- Deemed too fit or too unfit on sub-maximal treadmill test
- Non English Speaking
- > 4 consecutive weeks absence during the intervention period
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Centre
Edmonton, Alberta, T6G 1Z2
About this study
Official title: Breast Cancer and Exercise Trial in Alberta: The BETA Trial
The Breast Cancer and Exercise Trial (BETA Trial) is a randomized controlled trial aimed at understanding what dose (or volume) of exercise will best reduce the risk for breast cancer, particularly among women who are between the ages of 50-74. The primary aim is to compare the effects of a high versus moderate volume exercise intervention on specific biological intermediate endpoints for breast cancer in a group of previously inactive postmenopausal women
Read the detailed description
Overview The proposed project is an evolution from a previous randomized controlled intervention trial conducted by the applicants known as the Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial that examined how a one-year aerobic exercise intervention, as compared to a usual sedentary lifestyle, influenced specific hypothesized biologic mechanisms in the association between physical activity and breast cancer risk. In the proposed project, we plan to extend this research to examine how a one-year high versus moderate volume aerobic exercise intervention influences established and novel biologic mechanisms thought to influence breast cancer risk. We are specifically interested in studying what dose of exercise is required to influence the biologic mechanisms involved in breast cancer etiology.
Rationale and Significance Inadequate physical activity, high total caloric intake, and obesity, central adiposity and weight gain throughout lifetime are all clearly associated with increased postmenopausal breast cancer risk and are some of the few risk factors amenable to intervention. Over one third of breast cancer can be attributed to these three risk factors. The exact dose and type of physical activity required for breast cancer risk reduction, however, are unknown. No trials have been conducted that have systematically examined how different volumes of activity influence mechanisms in breast cancer etiology.
Study Aims The primary aim is to compare the effects of a high versus moderate volume exercise intervention on specific hormonal and biological intermediate endpoints for breast cancer in a group of previously sedentary postmenopausal women. The primary objectives will examine the effects of the interventions on measures of adiposity, insulin resistance, sex hormone levels, markers of obesity and inflammation and serum vitamin D. The secondary aim is to evaluate the impact of the high versus moderate exercise interventions among postmenopausal, sedentary women on psychosocial factors. The secondary objectives will compare the effects of the exercise interventions on quality of life and perceived stress among the participants. Adherence to the exercise intervention at 12 and maintenance of exercise at 24 months will also be assessed.
Research Plan A two-centered, two-armed randomized controlled trial is proposed. In total, 330 postmenopausal, sedentary women aged 50-74 years will be recruited from the screening programs and through media campaigns. Strict eligibility criteria will be applied to ensure that women enrolled in the study can be expected to have a change in breast cancer risk over the one-year long intervention. Randomization will be stratified on centre (Calgary or Edmonton) and on body mass index (< or ≥27.5). The intervention arm will undertake aerobic exercise sessions of 300 mins/week for 12 months. The control arm will be asked to undertake 150 mins/week for 12 months. Baseline and 12-month measurements of adiposity (done by computerized tomography and dual energy X-ray absorbitometry scans), fitness, diet, physical activity, quality of life and stress, determinants of exercise adherence and medical, health and demographic characteristics will be made. Bloods, drawn at baseline, six and 12 months, will be assayed to measure estrone, estradiol, testosterone, androstenedione, insulin, glucose, adiponectin, leptin, interleukin-6, tumour necrosing factor-alpha, C-reactive protein and serum hydroxyvitamin D. One year after completion of the study, maintenance of physical and dietary habits will be measured. Intent-to-treat analysis will be used with a Laird-Ware mixed effects model to compare the changes from the baseline to 12-month follow-up. These data will be of direct relevance for effectiveness trials of exercise and diet for breast cancer prevention and for refinement of physical activity guidelines.
- Conditions
- Breast Neoplasms
- Being tested
- Moderate Volume, High Volume
- Keywords
- Prevention and control, Exercise, Sedentary lifestyle, Biological markers
- Medical subject headings
- Breast Neoplasms, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate VolumeOther
Moderate volume (150 minutes per week) aerobic exercise
High VolumeOther
Participate in one-year high volume (300 minutes per week)aerobic exercise.
| Study group | Role | What they receive |
|---|---|---|
| High Volume | Active comparator | Participate in one year of high volume (300 minutes per week) aerobic exercise with free provision of a personal trainer, membership to an exercise facility, body composition assessment. Receives: Other: High Volume |
| Moderate Volume | Active comparator | Participate in one year of moderate volume (150 minutes per week) aerobic exercise with free provision of a personal trainer, membership to an exercise facility, body composition assessment. Receives: Other: Moderate Volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat
Body composition (including weight, hip circumference, waist circumference, waist-hip ratio, total body fat, subcutaneous fat, intra-abdominal fat, lean body mass, body mass index)
Measured: 36 Months
Secondary outcomes (3)
Insulin resistance
Measurements taken of Insulin Levels, Glucose Levels, Insulin Resistance (HOMA Score)
Measured: 36 months
Sex Hormone Levels
Measure levels of Estrone, Estradiol, Androstenedione and Testosterone
Measured: 36 months
Inflammation
Measure levels of C-Reactive protein, Interleukin-6 and Tumour necrosis factor.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startMar 2010
- Primary completionApr 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3 - To compare the effects of a high versus moderate volume exercise intervention on specific biological intermediate endpoints for breast cancer in a group of previously inactive postmenopausal women.
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Friedenreich, AHS Cancer Control Alberta
- Investigators
- Christine Friedenreich, PhD, Principal investigator, Tom Baker Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435005
- Sponsor's protocol ID
- ACF:24404
- Acronym
- BETA
- Status last verified
- Jan 2018
- First submitted
- 30 Aug 2011
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gonzalo-Encabo P, McNeil J, Perez-Lopez A, Valades D, Courneya KS, Friedenreich CM. Weight Regain and Breast Cancer-Related Biomarkers Following an Exercise Intervention in Postmenopausal Women. Cancer Epidemiol Biomarkers Prev. 2021 Jun;30(6):1260-1269. doi: 10.1158/1055-9965.EPI-20-1652. Epub 2021 Mar 18.
PubMed 33737300Brenner DR, Ruan Y, Adams SC, Courneya KS, Friedenreich CM. The impact of exercise on growth factors (VEGF and FGF2): results from a 12-month randomized intervention trial. Eur Rev Aging Phys Act. 2019 Jun 24;16:8. doi: 10.1186/s11556-019-0215-4. eCollection 2019.
PubMed 31285780Friedenreich CM, Ruan Y, Duha A, Courneya KS. Exercise Dose Effects on Body Fat 12 Months after an Exercise Intervention: Follow-up from a Randomized Controlled Trial. J Obes. 2019 Jan 20;2019:3916416. doi: 10.1155/2019/3916416. eCollection 2019.
PubMed 30805213Stone CR, Friedenreich CM, O'Reilly R, Farris MS, Vallerand JR, Kang DW, Courneya KS. Predictors of Adherence to Different Volumes of Exercise in the Breast Cancer and Exercise Trial in Alberta. Ann Behav Med. 2019 Mar 28;53(5):453-465. doi: 10.1093/abm/kay057.
PubMed 30020401McNeil J, Farris MS, Ruan Y, Merry H, Lynch BM, Matthews CE, Courneya KS, Friedenreich CM. Effects of prescribed aerobic exercise volume on physical activity and sedentary time in postmenopausal women: a randomized controlled trial. Int J Behav Nutr Phys Act. 2018 Mar 21;15(1):27. doi: 10.1186/s12966-018-0659-3.
PubMed 29562927Brenner DR, Ruan Y, Morielli AR, Courneya KS, Friedenreich CM. Physical activity does not alter prolactin levels in post-menopausal women: results from a dose-response randomized controlled trial. Eur Rev Aging Phys Act. 2017 Jul 13;14:10. doi: 10.1186/s11556-017-0179-1. eCollection 2017.
PubMed 28717404McNeil J, Brenner DR, Courneya KS, Friedenreich CM. Dose-response effects of aerobic exercise on energy compensation in postmenopausal women: combined results from two randomized controlled trials. Int J Obes (Lond). 2017 Aug;41(8):1196-1202. doi: 10.1038/ijo.2017.87. Epub 2017 Mar 31.
PubMed 28360432Courneya KS, McNeil J, O'Reilly R, Morielli AR, Friedenreich CM. Dose-Response Effects of Aerobic Exercise on Quality of Life in Postmenopausal Women: Results from the Breast Cancer and Exercise Trial in Alberta (BETA). Ann Behav Med. 2017 Jun;51(3):356-364. doi: 10.1007/s12160-016-9859-8.
PubMed 27837524Friedenreich CM, Neilson HK, Wang Q, Stanczyk FZ, Yasui Y, Duha A, MacLaughlin S, Kallal C, Forbes CC, Courneya KS. Effects of exercise dose on endogenous estrogens in postmenopausal women: a randomized trial. Endocr Relat Cancer. 2015 Oct;22(5):863-76. doi: 10.1530/ERC-15-0243.
PubMed 26338699Friedenreich CM, Neilson HK, O'Reilly R, Duha A, Yasui Y, Morielli AR, Adams SC, Courneya KS. Effects of a High vs Moderate Volume of Aerobic Exercise on Adiposity Outcomes in Postmenopausal Women: A Randomized Clinical Trial. JAMA Oncol. 2015 Sep;1(6):766-76. doi: 10.1001/jamaoncol.2015.2239.
PubMed 26181634Friedenreich CM, MacLaughlin S, Neilson HK, Stanczyk FZ, Yasui Y, Duha A, Lynch BM, Kallal C, Courneya KS. Study design and methods for the Breast Cancer and Exercise Trial in Alberta (BETA). BMC Cancer. 2014 Dec 6;14:919. doi: 10.1186/1471-2407-14-919.
PubMed 25480020
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer and Exercise Trial in Alberta: The BETA Trial
- ClinicalTrials.gov ID
- NCT01435005
- Acronym / sponsor ID
- BETA / ACF:24404
- Conditions
- Breast Neoplasms
- Keywords
- Prevention and control, Exercise, Sedentary lifestyle, Biological markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Breast Cancer and Exercise Trial (BETA Trial) is a randomized controlled trial aimed at understanding what dose (or volume) of exercise will best reduce the risk for breast cancer, particularly among women who are between the ages of 50-74. The primary aim is to compare the effects of a high versus moderate volume exercise intervention on specific biological intermediate endpoints for breast cancer in a group of previously inactive postmenopausal women
Detailed description
Overview The proposed project is an evolution from a previous randomized controlled intervention trial conducted by the applicants known as the Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial that examined how a one-year aerobic exercise intervention, as compared to a usual sedentary lifestyle, influenced specific hypothesized biologic mechanisms in the association between physical activity and breast cancer risk. In the proposed project, we plan to extend this research to examine how a one-year high versus moderate volume aerobic exercise intervention influences established and novel biologic mechanisms thought to influence breast cancer risk. We are specifically interested in studying what dose of exercise is required to influence the biologic mechanisms involved in breast cancer etiology.
Rationale and Significance Inadequate physical activity, high total caloric intake, and obesity, central adiposity and weight gain throughout lifetime are all clearly associated with increased postmenopausal breast cancer risk and are some of the few risk factors amenable to intervention. Over one third of breast cancer can be attributed to these three risk factors. The exact dose and type of physical activity required for breast cancer risk reduction, however, are unknown. No trials have been conducted that have systematically examined how different volumes of activity influence mechanisms in breast cancer etiology.
Study Aims The primary aim is to compare the effects of a high versus moderate volume exercise intervention on specific hormonal and biological intermediate endpoints for breast cancer in a group of previously sedentary postmenopausal women. The primary objectives will examine the effects of the interventions on measures of adiposity, insulin resistance, sex hormone levels, markers of obesity and inflammation and serum vitamin D. The secondary aim is to evaluate the impact of the high versus moderate exercise interventions among postmenopausal, sedentary women on psychosocial factors. The secondary objectives will compare the effects of the exercise interventions on quality of life and perceived stress among the participants. Adherence to the exercise intervention at 12 and maintenance of exercise at 24 months will also be assessed.
Research Plan A two-centered, two-armed randomized controlled trial is proposed. In total, 330 postmenopausal, sedentary women aged 50-74 years will be recruited from the screening programs and through media campaigns. Strict eligibility criteria will be applied to ensure that women enrolled in the study can be expected to have a change in breast cancer risk over the one-year long intervention. Randomization will be stratified on centre (Calgary or Edmonton) and on body mass index (< or ≥27.5). The intervention arm will undertake aerobic exercise sessions of 300 mins/week for 12 months. The control arm will be asked to undertake 150 mins/week for 12 months. Baseline and 12-month measurements of adiposity (done by computerized tomography and dual energy X-ray absorbitometry scans), fitness, diet, physical activity, quality of life and stress, determinants of exercise adherence and medical, health and demographic characteristics will be made. Bloods, drawn at baseline, six and 12 months, will be assayed to measure estrone, estradiol, testosterone, androstenedione, insulin, glucose, adiponectin, leptin, interleukin-6, tumour necrosing factor-alpha, C-reactive protein and serum hydroxyvitamin D. One year after completion of the study, maintenance of physical and dietary habits will be measured. Intent-to-treat analysis will be used with a Laird-Ware mixed effects model to compare the changes from the baseline to 12-month follow-up. These data will be of direct relevance for effectiveness trials of exercise and diet for breast cancer prevention and for refinement of physical activity guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 3 - To compare the effects of a high versus moderate volume exercise intervention on specific biological intermediate endpoints for breast cancer in a group of previously inactive postmenopausal women.
| Arm | Type | Receives |
|---|---|---|
| High Volume | Active comparator | Other: High VolumeParticipate in one year of high volume (300 minutes per week) aerobic exercise with free provision of a personal trainer, membership to an exercise facility, body composition assessment. |
| Moderate Volume | Active comparator | Other: Moderate VolumeParticipate in one year of moderate volume (150 minutes per week) aerobic exercise with free provision of a personal trainer, membership to an exercise facility, body composition assessment. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 50- 74 years, postmenopausal women
- No previous cancer diagnosis
- Physically fit to undertake exercise program
- Pass the Physical Activity Readiness
- Medical Exam,acceptable heart and lung function during a sub-maximal treadmill test
Key exclusion criteria (5 listed)
- < 50 years of age
- Diabetes
- Deemed too fit or too unfit on sub-maximal treadmill test
- Non English Speaking
- > 4 consecutive weeks absence during the intervention period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate VolumeModerate volume (150 minutes per week) aerobic exercise | Other | Moderate Volume |
| High VolumeParticipate in one-year high volume (300 minutes per week)aerobic exercise. | Other | High Volume |
Primary outcome
Body Fat
Time frame: 36 Months
Body composition (including weight, hip circumference, waist circumference, waist-hip ratio, total body fat, subcutaneous fat, intra-abdominal fat, lean body mass, body mass index)
3 secondary outcomes
Insulin resistance
Time frame: 36 months
Sex Hormone Levels
Time frame: 36 months
Inflammation
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Derived from this study: PubMed 33737300Gonzalo-Encabo P, McNeil J, Perez-Lopez A, Valades D, Courneya KS, Friedenreich CM. Weight Regain and Breast Cancer-Related Biomarkers Following an Exercise Intervention in Postmenopausal Women. Cancer Epidemiol Biomarkers Prev. 2021 Jun;30(6):1260-1269. doi: 10.1158/1055-9965.EPI-20-1652. Epub 2021 Mar 18.
- Derived from this study: PubMed 31285780Brenner DR, Ruan Y, Adams SC, Courneya KS, Friedenreich CM. The impact of exercise on growth factors (VEGF and FGF2): results from a 12-month randomized intervention trial. Eur Rev Aging Phys Act. 2019 Jun 24;16:8. doi: 10.1186/s11556-019-0215-4. eCollection 2019.
- Derived from this study: PubMed 30805213Friedenreich CM, Ruan Y, Duha A, Courneya KS. Exercise Dose Effects on Body Fat 12 Months after an Exercise Intervention: Follow-up from a Randomized Controlled Trial. J Obes. 2019 Jan 20;2019:3916416. doi: 10.1155/2019/3916416. eCollection 2019.
- Derived from this study: PubMed 30020401Stone CR, Friedenreich CM, O'Reilly R, Farris MS, Vallerand JR, Kang DW, Courneya KS. Predictors of Adherence to Different Volumes of Exercise in the Breast Cancer and Exercise Trial in Alberta. Ann Behav Med. 2019 Mar 28;53(5):453-465. doi: 10.1093/abm/kay057.
- Derived from this study: PubMed 29562927McNeil J, Farris MS, Ruan Y, Merry H, Lynch BM, Matthews CE, Courneya KS, Friedenreich CM. Effects of prescribed aerobic exercise volume on physical activity and sedentary time in postmenopausal women: a randomized controlled trial. Int J Behav Nutr Phys Act. 2018 Mar 21;15(1):27. doi: 10.1186/s12966-018-0659-3.
- Derived from this study: PubMed 28717404Brenner DR, Ruan Y, Morielli AR, Courneya KS, Friedenreich CM. Physical activity does not alter prolactin levels in post-menopausal women: results from a dose-response randomized controlled trial. Eur Rev Aging Phys Act. 2017 Jul 13;14:10. doi: 10.1186/s11556-017-0179-1. eCollection 2017.
- Derived from this study: PubMed 28360432McNeil J, Brenner DR, Courneya KS, Friedenreich CM. Dose-response effects of aerobic exercise on energy compensation in postmenopausal women: combined results from two randomized controlled trials. Int J Obes (Lond). 2017 Aug;41(8):1196-1202. doi: 10.1038/ijo.2017.87. Epub 2017 Mar 31.
- Derived from this study: PubMed 27837524Courneya KS, McNeil J, O'Reilly R, Morielli AR, Friedenreich CM. Dose-Response Effects of Aerobic Exercise on Quality of Life in Postmenopausal Women: Results from the Breast Cancer and Exercise Trial in Alberta (BETA). Ann Behav Med. 2017 Jun;51(3):356-364. doi: 10.1007/s12160-016-9859-8.
- Derived from this study: PubMed 26338699Friedenreich CM, Neilson HK, Wang Q, Stanczyk FZ, Yasui Y, Duha A, MacLaughlin S, Kallal C, Forbes CC, Courneya KS. Effects of exercise dose on endogenous estrogens in postmenopausal women: a randomized trial. Endocr Relat Cancer. 2015 Oct;22(5):863-76. doi: 10.1530/ERC-15-0243.
- Derived from this study: PubMed 26181634Friedenreich CM, Neilson HK, O'Reilly R, Duha A, Yasui Y, Morielli AR, Adams SC, Courneya KS. Effects of a High vs Moderate Volume of Aerobic Exercise on Adiposity Outcomes in Postmenopausal Women: A Randomized Clinical Trial. JAMA Oncol. 2015 Sep;1(6):766-76. doi: 10.1001/jamaoncol.2015.2239.
- Derived from this study: PubMed 25480020Friedenreich CM, MacLaughlin S, Neilson HK, Stanczyk FZ, Yasui Y, Duha A, Lynch BM, Kallal C, Courneya KS. Study design and methods for the Breast Cancer and Exercise Trial in Alberta (BETA). BMC Cancer. 2014 Dec 6;14:919. doi: 10.1186/1471-2407-14-919.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Friedenreich, PhD principal investigator
Tom Baker Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Volume and High Volume in people with Breast Neoplasms, run by AHS Cancer Control Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Fat (time frame: 36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01435005, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.