Breast CancerNCT02804308
Combined Training on Body Composition of Postmenopausal Women Undergoing Treatment for Breast Cancer
A study testing Combined Training in people with Breast Cancer and Aromatase Inhibitors, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial summary
Breast cancer is a multifactorial disease affecting women, and one of the treatments for its healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs that promote lower chance of metastasis, but their side effects include the loss of bone mineral density and increased fat percentage. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Aromatase Inhibitors, Postmenopausal
- What is being tested?
- Combined Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jun 2016
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal, defined by the absence of periods for the past 12 months;
- Breast cancer diagnosis stages 1 to 3;
- The adjuvant treatment for breast cancer and / or neoadjuvant aromatase inhibitors
- No abnormalities on screening physical or any health problems that contraindicate study participation;
- No contraindications for treadmill testing or entry into a training program, including any of the following:
- Myocardial infarction within the past 6 months
Show all 18Show fewer
- Pulmonary edema
- Myocarditis Pericarditis
- Unstable angina
- Pulmonary embolism or deep vein thrombosis
- Uncontrolled hypertension (i.e., blood pressure > 200/100 mm Hg)
- Uncontrolled arrhythmia
- No significant mental illness
- Have medical certificate to perform exercise testing and participate in combined training
- Able to answer Questionnaires
- No concurrent participation in any other organized exercise program;
- Live in Presidente Prudente
- Sign the consent form and formal clarification for participation in the study.
Who cannot join
- Accumulating 3 unexcused absences or 4 consecutive unexcused absences during the month.
About this study
Official title: Effectiveness of Physical Training on Body Composition, Physical Activity Level and Quality of Life of Postmenopausal Women Undergoing Treatment for Breast Cancer With Aromatase Inhibitors: The Randomized Clinical Trial.
Breast cancer is a multifactorial disease affecting women, and one of the treatments for its healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs that promote lower chance of metastasis, but their side effects include the loss of bone mineral density and increased fat percentage. In this way, the Combined Training (combined resistance and endurance training) may be an interesting strategy to minimize the side effects of aromatase inhibitors, providing better quality of life, survival and changes in body composition.
- Conditions
- Breast Cancer, Aromatase Inhibitors, Postmenopausal
- Being tested
- Combined Training
- Keywords
- Combined Training, Breast Cancer, Body Composition, Postmenopausal Women, Aromatase Inhibitors, Quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined TrainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group Control with breast cancer and without breast cancer | No intervention | Stretching exercises, lasting 40 minutes each session, 2 times a week for nine months |
| Combined Training with breast cancer and without breast cancer | Experimental | Combined Training: 36 weeks duration, 3 times a week on nonconsecutive days. The combined training program lasts 70 minutes per session, with 40 minutes of resistance training and 30 minutes of aerobic training. Receives: Behavioral: Combined Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chance from Body composition at 9 months assessment by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT
Measured: At baseline, 3, 6 and 9 months timepoint
Secondary outcomes (14)
Quality of life assessed via the questionnaire EORTC (European Organization for Research and Treatment of Cancer Quality of Life Questionnarie).
Measured: At baseline, 3, 6 and 9 months timepoint
Bone mineral density (total, spine and femur) in these participants by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT.
Measured: At baseline, 3, 6 and 9 months timepoint
Serum levels of glucose in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5
Measured: At baseline, 3, 6 and 9 months timepoint
Serum levels of C-reactive protein (CRP) in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5
Measured: At baseline, 3, 6 and 9 months timepoint
Serum levels of total cholesterol and fractions in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5.
Measured: At baseline, 3, 6 and 9 months timepoint
Serum levels of triacylglycerol in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5
Measured: At baseline, 3, 6 and 9 months timepoint
Serum of osteocalcin and the carboxyterminal telopeptides of collagen type I (CTX) measured at Serum CrossLaps Assay
Measured: At baseline, 3, 6 and 9 months timepoint
Physical Activity of accelerometer motion sensor type triaxial Actigraph brand, mode GT3X.
Measured: At baseline, 3, 6 and 9 months timepoint
The perception of pain is measured by Pain Brief Questionnaire (PBQ
Measured: At baseline, 3, 6 and 9 months timepoint
VO2max by test of submaximal effort
Measured: At baseline, 3, 6 and 9 months timepoint
Responsiveness on body composition by bone densitometry (Dual-energy x-ray absorptiometry).
Measured: At baseline, 3 and 6 months timepoint
Responsiveness on habitual physical activity by accelerometer motion sensor type triaxial Actigraph brand, mode GT3X (Actigraph LLC, Pensacola, FL).
Measured: At baseline, 3 and 6 months timepoint
Use time of aromatase inhibitor and the response to combined training in the variables of body composition and level of physical activity by bone densitometry (GE Lunar - DPX-NT) and accelerometer motion sensor type triaxial Actigraph brand, mode GT3X
Measured: At baseline, 3 and 6 months timepoint
Self reported Drug consumption questionnaire
Measured: At baseline, 3, 6 and 9 months timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thais Reis Silva de Paulo, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Ismael F Freitas Junior, Doctor, Study director, UPECLIN HC FM Botucatu Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804308
- Sponsor's protocol ID
- CAAE46727715100005402
- Status last verified
- Mar 2015
- First submitted
- 10 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Felipe J, Viezel J, Reis AD, da Costa Barros EA, de Paulo TRS, Neves LM, Junior IFF. Relationship of different intensities of physical activity and quality of life in postmenopausal women. Health Qual Life Outcomes. 2020 May 6;18(1):123. doi: 10.1186/s12955-020-01377-1.
PubMed 32375779
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Training on Body Composition, Physical Activity Level and Quality of Life of Postmenopausal Women Undergoing Treatment for Breast Cancer With Aromatase Inhibitors: The Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02804308
- Acronym / sponsor ID
- CAAE46727715100005402
- Conditions
- Breast Cancer, Aromatase Inhibitors, Postmenopausal
- Keywords
- Combined Training, Breast Cancer, Body Composition, Postmenopausal Women, Aromatase Inhibitors, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Jun 2016 (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.
Breast cancer is a multifactorial disease affecting women, and one of the treatments for its healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs that promote lower chance of metastasis, but their side effects include the loss of bone mineral density and increased fat percentage. In this way, the Combined Training (combined resistance and endurance training) may be an interesting strategy to minimize the side effects of aromatase inhibitors, providing better quality of life, survival and changes in body composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Control with breast cancer and without breast cancer | No intervention | –Stretching exercises, lasting 40 minutes each session, 2 times a week for nine months |
| Combined Training with breast cancer and without breast cancer | Experimental | Behavioral: Combined TrainingCombined Training: 36 weeks duration, 3 times a week on nonconsecutive days. The combined training program lasts 70 minutes per session, with 40 minutes of resistance training and 30 minutes of aerobic training. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Postmenopausal, defined by the absence of periods for the past 12 months;
- Breast cancer diagnosis stages 1 to 3;
- The adjuvant treatment for breast cancer and / or neoadjuvant aromatase inhibitors
- No abnormalities on screening physical or any health problems that contraindicate study participation;
- No contraindications for treadmill testing or entry into a training program, including any of the following:
Key exclusion criteria (1 listed)
- Accumulating 3 unexcused absences or 4 consecutive unexcused absences during the month.
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 |
|---|---|---|
| Combined Training | Behavioural | Combined Training with breast cancer and without breast cancer |
Primary outcome
Chance from Body composition at 9 months assessment by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT
Time frame: At baseline, 3, 6 and 9 months timepoint
14 secondary outcomes
Quality of life assessed via the questionnaire EORTC (European Organization for Research and Treatment of Cancer Quality of Life Questionnarie).
Time frame: At baseline, 3, 6 and 9 months timepoint
Bone mineral density (total, spine and femur) in these participants by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT.
Time frame: At baseline, 3, 6 and 9 months timepoint
Serum levels of glucose in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5
Time frame: At baseline, 3, 6 and 9 months timepoint
Serum levels of C-reactive protein (CRP) in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5
Time frame: At baseline, 3, 6 and 9 months timepoint
Serum levels of total cholesterol and fractions in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5.
Time frame: At baseline, 3, 6 and 9 months timepoint
Serum levels of triacylglycerol in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5
Time frame: At baseline, 3, 6 and 9 months timepoint
Serum of osteocalcin and the carboxyterminal telopeptides of collagen type I (CTX) measured at Serum CrossLaps Assay
Time frame: At baseline, 3, 6 and 9 months timepoint
Physical Activity of accelerometer motion sensor type triaxial Actigraph brand, mode GT3X.
Time frame: At baseline, 3, 6 and 9 months timepoint
The perception of pain is measured by Pain Brief Questionnaire (PBQ
Time frame: At baseline, 3, 6 and 9 months timepoint
VO2max by test of submaximal effort
Time frame: At baseline, 3, 6 and 9 months timepoint
Responsiveness on body composition by bone densitometry (Dual-energy x-ray absorptiometry).
Time frame: At baseline, 3 and 6 months timepoint
Responsiveness on habitual physical activity by accelerometer motion sensor type triaxial Actigraph brand, mode GT3X (Actigraph LLC, Pensacola, FL).
Time frame: At baseline, 3 and 6 months timepoint
Use time of aromatase inhibitor and the response to combined training in the variables of body composition and level of physical activity by bone densitometry (GE Lunar - DPX-NT) and accelerometer motion sensor type triaxial Actigraph brand, mode GT3X
Time frame: At baseline, 3 and 6 months timepoint
Self reported Drug consumption questionnaire
Time frame: At baseline, 3, 6 and 9 months timepoint
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 17 Jun 2016.
- Derived from this study: PubMed 32375779Felipe J, Viezel J, Reis AD, da Costa Barros EA, de Paulo TRS, Neves LM, Junior IFF. Relationship of different intensities of physical activity and quality of life in postmenopausal women. Health Qual Life Outcomes. 2020 May 6;18(1):123. doi: 10.1186/s12955-020-01377-1.
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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, Doctor study director
UPECLIN HC FM Botucatu Unesp
Questions about this trial
What is this clinical trial studying?
A study testing Combined Training in people with Breast Cancer and Aromatase Inhibitors, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
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 18 inclusion and 1 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 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Chance from Body composition at 9 months assessment by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT (time frame: At baseline, 3, 6 and 9 months timepoint). 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 NCT02804308, which also lists 1 linked publication.
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 17 Jun 2016.