Breast NeoplasmsNCT02584712
Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients
A study testing Combined Exercise Training in people with Breast Neoplasms and Autonomic Nervous System Diseases, run by Federal University of Maranhao.
Trial summary
The aim of this study is to evaluate the effect of exercise training in the autonomic nervous system activity in breast cancer patients, who underwent doxorubicin medication. Read more about this study
- Who is it for?
- Ages 30 to 59 years, women only
- Conditions the study is for
- Breast Neoplasms, Autonomic Nervous System Diseases
- What is being tested?
- Combined Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 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 30 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Breast cancer patients at stages 1, 2 and 3;
- Sedentary;
- Currently at treatment;
- 4-6 months after surgery
Who cannot join
- Musculoskeletal injuries or disorders;
- Mental illnesses
- Stage 4 (Metastasis)
- Enrolled in other exercise program
About this study
Official title: Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients Treated With Doxorubicin
The aim of this study is to evaluate the effect of exercise training in the autonomic nervous system activity in breast cancer patients, who underwent doxorubicin medication.
- Being tested
- Combined Exercise Training
- Medical subject headings
- Breast Neoplasms, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Exercise TrainingOther
Also called Exercise
This intervention consisted in 4 weeks of strength, flexibility and aerobic exercises made at the hospital and at home.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group do not participated in the intervention protocol (exercise training), and was followed throughout the entire process. Autonomic activity was assessed before and after 4 weeks. |
| Exercise Training | Active comparator | This group undergone exercise training intervention during 4 weeks. Receives: Other: Combined Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Low Frequency Heart rate variability component (LF)
This reduction is positive, indicating a reduction in sympathetic activity and thus the cardiovascular risk
Measured: 4 weeks
Increase in High Frequency heart rate variability component (HF)
Means a increase in parasympathetic activity, which is correlated to reduction in cardiovascular risk
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Maranhao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiano Teixeira Mostarda, Federal University of Maranhao
- Investigators
- Cristiano T Mostarda, PhD, Principal investigator, Federal University of Maranhao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584712
- Sponsor's protocol ID
- FUMaranhao
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2015
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients Treated With Doxorubicin
- ClinicalTrials.gov ID
- NCT02584712
- Acronym / sponsor ID
- FUMaranhao
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Federal University of MaranhaoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- First posted
- 23 Oct 2015 (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 aim of this study is to evaluate the effect of exercise training in the autonomic nervous system activity in breast cancer patients, who underwent doxorubicin medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group do not participated in the intervention protocol (exercise training), and was followed throughout the entire process. Autonomic activity was assessed before and after 4 weeks. |
| Exercise Training | Active comparator | Other: Combined Exercise TrainingThis group undergone exercise training intervention during 4 weeks. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Breast cancer patients at stages 1, 2 and 3;
- Sedentary;
- Currently at treatment;
- 4-6 months after surgery
Key exclusion criteria (4 listed)
- Musculoskeletal injuries or disorders;
- Mental illnesses
- Stage 4 (Metastasis)
- Enrolled in other exercise program
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 Exercise TrainingAlso: ExerciseThis intervention consisted in 4 weeks of strength, flexibility and aerobic exercises made at the hospital and at home. | Other | Exercise Training |
Primary outcome
Reduction in Low Frequency Heart rate variability component (LF)
Time frame: 4 weeks
This reduction is positive, indicating a reduction in sympathetic activity and thus the cardiovascular risk
Increase in High Frequency heart rate variability component (HF)
Time frame: 4 weeks
Means a increase in parasympathetic activity, which is correlated to reduction in cardiovascular risk
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 23 Oct 2015.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Cristiano T Mostarda, PhD principal investigator
Federal University of Maranhao
Questions about this trial
What is this clinical trial studying?
A study testing Combined Exercise Training in people with Breast Neoplasms and Autonomic Nervous System Diseases, run by Federal University of Maranhao.
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 4 inclusion and 4 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 23 Oct 2015. 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?
Reduction in Low Frequency Heart rate variability component (LF) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2015.