Cancer of BreastATTBCNCT03494400
Aerobic Training in Treatment for Breast Cancer
A study testing Aerobic Training Presential and Aerobic Training Home-based in people with Cancer of Breast and Healthy, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
Introduction. Treatment with hormone therapy reduced the likelihood of tumor recurrence and metastasis in the patient. However, it has adverse effects such as: loss of bone mineral density, increase in body weight, metabolic changes and, consequently, lower quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer of Breast, Healthy
- What is being tested?
- Aerobic Training Presential and Aerobic Training Home-based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2018to 30 Nov 2020
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of breast cancer;
- Perform Tamoxifen or Aromatase Inhibitor Treatment;
- Being in stages 1 to 3 of breast cancer;
- Do not present physical limitations or any health problem that prevents the performance of the evaluations and the training;
- Have a medical certificate to perform the ergometric test and participate in physical training;
- Not practicing physical training in the last six months;
Show all 9Show fewer
- Sign the Term of Free Consent and Clarification.
- Do not use Tamoxifen or Aromatase Inhibitor;
- Not being diagnosed with any type of cancer.
Who cannot join
- Accumulate three consecutive absences or four non-consecutive absences in presential training during the month;
- Failure to attend the scheduled bi-weekly activities in the case of the home-based training group;
- Do not send information about the activities carried out in the case of the home-based group
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista Júlio de Mesquita Filho
Presidente Prudente, São Paulo, 19060-560
About this study
Official title: Effects of Aerobic Training in Treatment for Breast Cancer
Introduction. Treatment with hormone therapy reduced the likelihood of tumor recurrence and metastasis in the patient. However, it has adverse effects such as: loss of bone mineral density, increase in body weight, metabolic changes and, consequently, lower quality of life. Physical training has been used as a means of reducing these and other adverse effects, but there is no definite protocol on which training model is effective, especially in patients who only use Tamoxifen or Aromatase Inhibitor as an adjuvant therapy for treatment of breast cancer.
Objective: To compare the effect of aerobic training on body composition, metabolic and inflammatory variables, physical activity level, sleep, anxiety, depression, body image, fatigue, strength, flexibility and quality of life of women undergoing breast cancer treatment use Tamoxifen and Aromatase Inhibitor and women without cancer.
Method. The sample will be formed by women without cancer and under treatment with hormone therapy being accompanied by the public service for treatment of breast cancer of the city of Presidente Prudente. A 24-week notification in which the face-to-face training group will undergo aerobic training three times a week on interspersed days and the group accompanied at a distance will perform as a preferred activity under a distance supervision of professionals every 14 days of return to attend the UNESP for the adequacy of the analysis and selection of attendance to the proposed activities. Evaluations of the variables of interest at the baseline of the intervention will be performed after 12 weeks and soon after the intervention. The investigators will analyze: biomarkers (TNFα, LDL, HDL, VLDL, as well as in the lipid profile (triglycerides, total cholesterol and LDL fractions ), glycemia, insulin, anthropometric measurements, physical activity level, sleep, pain, anxiety, depression, body image, fatigue, strength, flexibility. Trainings will be performed within the target zone of maximum heart rate. Comparisons between groups at each time point will be performed using Student's T-test for independent samples. The comparisons of the variables of interest at the initial moment and after 12 and 24 weeks will be made through the multivariate analysis, where the group effects, time and interaction of both will be compared. All analyzes will be performed in SPSS software version 24.0 and significance of 5%.
Read the detailed description
Introduction. Breast cancer is one of the leading causes of morbidity and mortality in the world.Treatment with hormone therapy reduced the likelihood of tumor recurrence and metastasis in the patient. However, it has adverse effects such as: loss of bone mineral density, increase in body weight, metabolic changes (lipid and low grade systemic inflammation) and, consequently, lower quality of life. Physical training has been used as a means of reducing these and other adverse effects, but there is no definite protocol on which training model is effective, especially in patients who only use Tamoxifen or Aromatase Inhibitor as an adjuvant therapy for treatment of breast cancer.
Objective: To compare the effect of aerobic training on body composition, metabolic and inflammatory variables, physical activity level, sleep, anxiety, depression, body image, fatigue, strength, flexibility and quality of life of women undergoing breast cancer treatment use Tamoxifen and Aromatase Inhibitor and women without cancer.
Method. The sample will be formed by women without cancer and under treatment with hormone therapy being accompanied by the public service for treatment of breast cancer of the city of Presidente Prudente. Where participants will be distributed in six groups submitted to intervention with aerobic training: Tamoxifen group with face-to-face training (GTP); Aromatase Inhibitor Group with face-to-face training (GIP); Tamoxifen training group by distance monitoring (GTA); Training group Aromatase inhibitor by distance monitoring (GIA); Group without training with cancer (GC) and Group training face-to-face without cancer (GTSC). A 24-week notification in which the face-to-face training group will undergo aerobic training three times a week on interspersed days and the group accompanied at a distance will perform as a preferred activity under a distance supervision of professionals every 14 days of return to attend the UNESP for the adequacy of the analysis and selection of attendance to the proposed activities. Evaluations of the variables of interest at the baseline of the intervention will be performed after 12 weeks and soon after the intervention. The investigators will analyze: biomarkers will analyze: biomarkers (Tumor Necrosis Factor-Alpha (TNFα), (LDL), High Density Lipoprotein (HDL), and Very Low Density Lipoprotein (VLDL), as well as in the lipid profile (triglycerides, total cholesterol and low density lipoprotein (LDL) fractions) ), glycemia, insulin, anthropometric measurements, physical activity level, sleep, pain, anxiety, depression, body image, fatigue, strength, flexibility. Trainings will be performed within the target zone of maximum heart rate. Comparisons between groups at each time point will be performed using Student's T-test for independent samples. The comparisons of the variables of interest at the initial moment and after 12 and 24 weeks will be made through the multivariate analysis, where the group effects, time and interaction of both will be compared. All analyzes will be performed in SPSS software version 24.0 and significance of 5%.
- Conditions
- Cancer of Breast, Healthy
- Being tested
- Aerobic Training Presential, Aerobic Training Home-based
- Keywords
- Breast cancer, Physical exercise, Body mass
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Training PresentialOther
Also called Physical exercise Presential
The intervention will last 24 weeks, in which the presential training group will undergo aerobic training three times a week on interspersed days, more follow-up.
Aerobic Training Home-basedOther
Also called Physical exercise Home-based
The intervention will last 24 weeks, the group accompanied by the distance will carry out the activities in their preferred place under the distance supervision of professionals and every 14 days must attend the UNESP to adjust the intensity and verification of attendance to the proposed activities, more follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Presential Aerobic Training with Hormone Therapy | Experimental | A group of women with breast cancer who use Tamoxifen or Aromatase Inhibitor and will perform presential aerobic training. Receives: Other: Aerobic Training Presential |
| Presential Aerobic Training without Breast Cancer | Active comparator | A group of women without breast cancer who use Aromatase Inhibitor and will perform presential aerobic training. Receives: Other: Aerobic Training Presential |
| Home-based Aerobic Training with Hormone Therapy | Experimental | A group of women with breast cancer who use Tamoxifen or Aromatase Inhibitor and will perform home-based aerobic training. Receives: Other: Aerobic Training Home-based |
| Home-based Aerobic Training without Breast Cancer | Active comparator | A group of women without breast cancer who use Aromatase Inhibitor and will perform aerobic training home-based. Receives: Other: Aerobic Training Home-based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of body composition by Bone Densitometry (DEXA) equipment
Reduction of body mass and of increased fat free mass
Measured: 24 week
Secondary outcomes (5)
Evaluation of quality of life by questionnarie EORTC-QLQ-30
Increased of quality of life global
Measured: 24 week
Evaluation inflammatory response by ELISA equipment
Reduction of interleukin- IL 6
Measured: 24 week
Evaluation of pain by questionnarie BPI.
Reduction of pain intensity to increased of functional capacity
Measured: 24 week
Evaluation of level of physical activity by triaxial accelerometer equipment
Increased of level of physical activity
Measured: 24 week
Nutritional evaluation by food register
Increased of quality of food
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Jul 2018
- Primary completion23 Jun 2019
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cancer of BreastStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andréa Dias Reis, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- ISMAEL F FREITAS JUNIOR, Study director, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494400
- Sponsor's protocol ID
- State University of São Paulo
- Acronym
- ATTBC
- Status last verified
- Apr 2021
- First submitted
- 14 Mar 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Battaglini CL, Mills RC, Phillips BL, Lee JT, Story CE, Nascimento MG, Hackney AC. Twenty-five years of research on the effects of exercise training in breast cancer survivors: A systematic review of the literature. World J Clin Oncol. 2014 May 10;5(2):177-90. doi: 10.5306/wjco.v5.i2.177.
PubMed 24829866Do J, Cho Y, Jeon J. Effects of a 4-week multimodal rehabilitation program on quality of life, cardiopulmonary function, and fatigue in breast cancer patients. J Breast Cancer. 2015 Mar;18(1):87-96. doi: 10.4048/jbc.2015.18.1.87. Epub 2015 Mar 27.
PubMed 25834616Eriksen AK, Hansen RD, Borre M, Larsen RG, Jensen JM, Overgaard K, Borre M, Kyro C, Landberg R, Olsen A, Tjonneland A. A lifestyle intervention among elderly men on active surveillance for non-aggressive prostate cancer: a randomised feasibility study with whole-grain rye and exercise. Trials. 2017 Jan 13;18(1):20. doi: 10.1186/s13063-016-1734-1.
PubMed 28086943Nyrop KA, Callahan LF, Rini C, Altpeter M, Hackney B, Schecher A, Wilson A, Muss HB. Adaptation of an Evidence-Based Arthritis Program for Breast Cancer Survivors on Aromatase Inhibitor Therapy Who Experience Joint Pain. Prev Chronic Dis. 2015 Jun 11;12:E91. doi: 10.5888/pcd12.140535.
PubMed 26068412Travier N, Velthuis MJ, Steins Bisschop CN, van den Buijs B, Monninkhof EM, Backx F, Los M, Erdkamp F, Bloemendal HJ, Rodenhuis C, de Roos MA, Verhaar M, ten Bokkel Huinink D, van der Wall E, Peeters PH, May AM. Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial. BMC Med. 2015 Jun 8;13:121. doi: 10.1186/s12916-015-0362-z.
PubMed 26050790
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Training in Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT03494400
- Acronym / sponsor ID
- ATTBC / State University of São Paulo
- Conditions
- Cancer of Breast, Healthy
- Keywords
- Breast cancer, Physical exercise, Body mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 23 Jun 2019 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 11 Apr 2018 (actual)
- 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.
Introduction. Treatment with hormone therapy reduced the likelihood of tumor recurrence and metastasis in the patient. However, it has adverse effects such as: loss of bone mineral density, increase in body weight, metabolic changes and, consequently, lower quality of life. Physical training has been used as a means of reducing these and other adverse effects, but there is no definite protocol on which training model is effective, especially in patients who only use Tamoxifen or Aromatase Inhibitor as an adjuvant therapy for treatment of breast cancer.
Objective: To compare the effect of aerobic training on body composition, metabolic and inflammatory variables, physical activity level, sleep, anxiety, depression, body image, fatigue, strength, flexibility and quality of life of women undergoing breast cancer treatment use Tamoxifen and Aromatase Inhibitor and women without cancer.
Method. The sample will be formed by women without cancer and under treatment with hormone therapy being accompanied by the public service for treatment of breast cancer of the city of Presidente Prudente. A 24-week notification in which the face-to-face training group will undergo aerobic training three times a week on interspersed days and the group accompanied at a distance will perform as a preferred activity under a distance supervision of professionals every 14 days of return to attend the UNESP for the adequacy of the analysis and selection of attendance to the proposed activities. Evaluations of the variables of interest at the baseline of the intervention will be performed after 12 weeks and soon after the intervention. The investigators will analyze: biomarkers (TNFα, LDL, HDL, VLDL, as well as in the lipid profile (triglycerides, total cholesterol and LDL fractions ), glycemia, insulin, anthropometric measurements, physical activity level, sleep, pain, anxiety, depression, body image, fatigue, strength, flexibility. Trainings will be performed within the target zone of maximum heart rate. Comparisons between groups at each time point will be performed using Student's T-test for independent samples. The comparisons of the variables of interest at the initial moment and after 12 and 24 weeks will be made through the multivariate analysis, where the group effects, time and interaction of both will be compared. All analyzes will be performed in SPSS software version 24.0 and significance of 5%.
Detailed description
Introduction. Breast cancer is one of the leading causes of morbidity and mortality in the world.Treatment with hormone therapy reduced the likelihood of tumor recurrence and metastasis in the patient. However, it has adverse effects such as: loss of bone mineral density, increase in body weight, metabolic changes (lipid and low grade systemic inflammation) and, consequently, lower quality of life. Physical training has been used as a means of reducing these and other adverse effects, but there is no definite protocol on which training model is effective, especially in patients who only use Tamoxifen or Aromatase Inhibitor as an adjuvant therapy for treatment of breast cancer.
Objective: To compare the effect of aerobic training on body composition, metabolic and inflammatory variables, physical activity level, sleep, anxiety, depression, body image, fatigue, strength, flexibility and quality of life of women undergoing breast cancer treatment use Tamoxifen and Aromatase Inhibitor and women without cancer.
Method. The sample will be formed by women without cancer and under treatment with hormone therapy being accompanied by the public service for treatment of breast cancer of the city of Presidente Prudente. Where participants will be distributed in six groups submitted to intervention with aerobic training: Tamoxifen group with face-to-face training (GTP); Aromatase Inhibitor Group with face-to-face training (GIP); Tamoxifen training group by distance monitoring (GTA); Training group Aromatase inhibitor by distance monitoring (GIA); Group without training with cancer (GC) and Group training face-to-face without cancer (GTSC). A 24-week notification in which the face-to-face training group will undergo aerobic training three times a week on interspersed days and the group accompanied at a distance will perform as a preferred activity under a distance supervision of professionals every 14 days of return to attend the UNESP for the adequacy of the analysis and selection of attendance to the proposed activities. Evaluations of the variables of interest at the baseline of the intervention will be performed after 12 weeks and soon after the intervention. The investigators will analyze: biomarkers will analyze: biomarkers (Tumor Necrosis Factor-Alpha (TNFα), (LDL), High Density Lipoprotein (HDL), and Very Low Density Lipoprotein (VLDL), as well as in the lipid profile (triglycerides, total cholesterol and low density lipoprotein (LDL) fractions) ), glycemia, insulin, anthropometric measurements, physical activity level, sleep, pain, anxiety, depression, body image, fatigue, strength, flexibility. Trainings will be performed within the target zone of maximum heart rate. Comparisons between groups at each time point will be performed using Student's T-test for independent samples. The comparisons of the variables of interest at the initial moment and after 12 and 24 weeks will be made through the multivariate analysis, where the group effects, time and interaction of both will be compared. All analyzes will be performed in SPSS software version 24.0 and significance of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Presential Aerobic Training with Hormone Therapy | Experimental | Other: Aerobic Training PresentialA group of women with breast cancer who use Tamoxifen or Aromatase Inhibitor and will perform presential aerobic training. |
| Presential Aerobic Training without Breast Cancer | Active comparator | Other: Aerobic Training PresentialA group of women without breast cancer who use Aromatase Inhibitor and will perform presential aerobic training. |
| Home-based Aerobic Training with Hormone Therapy | Experimental | Other: Aerobic Training Home-basedA group of women with breast cancer who use Tamoxifen or Aromatase Inhibitor and will perform home-based aerobic training. |
| Home-based Aerobic Training without Breast Cancer | Active comparator | Other: Aerobic Training Home-basedA group of women without breast cancer who use Aromatase Inhibitor and will perform aerobic training home-based. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of breast cancer;
- Perform Tamoxifen or Aromatase Inhibitor Treatment;
- Being in stages 1 to 3 of breast cancer;
- Do not present physical limitations or any health problem that prevents the performance of the evaluations and the training;
- Have a medical certificate to perform the ergometric test and participate in physical training;
Key exclusion criteria (3 listed)
- Accumulate three consecutive absences or four non-consecutive absences in presential training during the month;
- Failure to attend the scheduled bi-weekly activities in the case of the home-based training group;
- Do not send information about the activities carried out in the case of the home-based group
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 |
|---|---|---|
| Aerobic Training PresentialAlso: Physical exercise PresentialThe intervention will last 24 weeks, in which the presential training group will undergo aerobic training three times a week on interspersed days, more follow-up. | Other | Presential Aerobic Training with Hormone Therapy, Presential Aerobic Training without Breast Cancer |
| Aerobic Training Home-basedAlso: Physical exercise Home-basedThe intervention will last 24 weeks, the group accompanied by the distance will carry out the activities in their preferred place under the distance supervision of professionals and every 14 days must attend the UNESP to adjust the intensity and verification of attendance to the proposed activities, more follow-up. | Other | Home-based Aerobic Training with Hormone Therapy, Home-based Aerobic Training without Breast Cancer |
Primary outcome
Evaluation of body composition by Bone Densitometry (DEXA) equipment
Time frame: 24 week
Reduction of body mass and of increased fat free mass
5 secondary outcomes
Evaluation of quality of life by questionnarie EORTC-QLQ-30
Time frame: 24 week
Evaluation inflammatory response by ELISA equipment
Time frame: 24 week
Evaluation of pain by questionnarie BPI.
Time frame: 24 week
Evaluation of level of physical activity by triaxial accelerometer equipment
Time frame: 24 week
Nutritional evaluation by food register
Time frame: 24 week
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 Apr 2021.
- Background: PubMed 24829866Battaglini CL, Mills RC, Phillips BL, Lee JT, Story CE, Nascimento MG, Hackney AC. Twenty-five years of research on the effects of exercise training in breast cancer survivors: A systematic review of the literature. World J Clin Oncol. 2014 May 10;5(2):177-90. doi: 10.5306/wjco.v5.i2.177.
- Background: PubMed 25834616Do J, Cho Y, Jeon J. Effects of a 4-week multimodal rehabilitation program on quality of life, cardiopulmonary function, and fatigue in breast cancer patients. J Breast Cancer. 2015 Mar;18(1):87-96. doi: 10.4048/jbc.2015.18.1.87. Epub 2015 Mar 27.
- Background: PubMed 28086943Eriksen AK, Hansen RD, Borre M, Larsen RG, Jensen JM, Overgaard K, Borre M, Kyro C, Landberg R, Olsen A, Tjonneland A. A lifestyle intervention among elderly men on active surveillance for non-aggressive prostate cancer: a randomised feasibility study with whole-grain rye and exercise. Trials. 2017 Jan 13;18(1):20. doi: 10.1186/s13063-016-1734-1.
- Background: PubMed 26068412Nyrop KA, Callahan LF, Rini C, Altpeter M, Hackney B, Schecher A, Wilson A, Muss HB. Adaptation of an Evidence-Based Arthritis Program for Breast Cancer Survivors on Aromatase Inhibitor Therapy Who Experience Joint Pain. Prev Chronic Dis. 2015 Jun 11;12:E91. doi: 10.5888/pcd12.140535.
- Background: PubMed 26050790Travier N, Velthuis MJ, Steins Bisschop CN, van den Buijs B, Monninkhof EM, Backx F, Los M, Erdkamp F, Bloemendal HJ, Rodenhuis C, de Roos MA, Verhaar M, ten Bokkel Huinink D, van der Wall E, Peeters PH, May AM. Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial. BMC Med. 2015 Jun 8;13:121. doi: 10.1186/s12916-015-0362-z.
- 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.
ISMAEL F FREITAS JUNIOR study director
Universidade Estadual Paulista Júlio de Mesquita Filho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Training Presential and Aerobic Training Home-based in people with Cancer of Breast and Healthy, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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 3 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 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Evaluation of body composition by Bone Densitometry (DEXA) equipment (time frame: 24 week). 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 NCT03494400, which also lists 5 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 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.