CancerPhase 1NCT02876627
Effect Aerobic Training on Women With Breast Cancer After Chemotherapy
A Phase 1 study testing Exercise training in people with Cancer and Exercise, run by University of Isfahan.
Trial summary
Introduction: The purpose of this study was to determine the effect of twelve weeks of aerobic exercise program on erythrocyte levels in women with breast cancer after chemotherapy. Read more about this study
- Who is it for?
- Ages 47 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer, Exercise, Hemoglobins
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Apr 2016
- Phase
- Phase 1
- 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 47 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women with breast cancer , who can do a physical, physiological and psychological test; and did not have exercise limitations due to neuromuscular and/or musculoskeletal disease; did not have any health problems that prevented maximum effort on the treadmill test.
Who cannot join
- women under erythropoietin treatments, uncontrolled cardiovascular or pulmonary diseases, uncontrolled arrhythmias, orthopedic conditions that would limit exercise participation, refusal for randomization, or participation in aerobic exercise training within 3 months before beginning the study.
About this study
Official title: The Effect of 12 Weeks of Aerobic Training Program on Erythrocyte Levels in Women With Breast Cancer After Chemotherapy
Introduction: The purpose of this study was to determine the effect of twelve weeks of aerobic exercise program on erythrocyte levels in women with breast cancer after chemotherapy.
Methods: Thirty women with breast cancer after chemotherapy of Sydalshhda hospital (aged between 47-65 years) volunteered for this study, and then randomly selected an exercise (n = 15) and control (n = 15) groups. Exercise group completed a twelve-week aerobic exercise training program consisted of three sessions per week, each session lasting 30 to 60 minutes 50 to 75 percent of their maximum heart rate reserve, while the control group were followed. Blood samples including red blood cell counts (RBC), hematocrit (HCT), hemoglobin (HB), peak oxygen consumption before and after 12 weeks of aerobic exercise were measured. For analysis of data, repeated-measures analysis of variance (ANOVA) was used.
- Conditions
- Cancer, Exercise, Hemoglobins
- Being tested
- Exercise training
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
twelve-week aerobic exercise training program consisted of three sessions per week, each session lasting 30 to 60 minutes 50 to 75 percent of their maximum heart rate reserve
| Study group | Role | What they receive |
|---|---|---|
| breast cancer | Experimental | Effect of exercise training on breast cancer patient Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of exercise on CBC parameters (measured by ELISA methods)
Measured: up to 12 weeks
Secondary outcomes (1)
effect of exercise on peak oxygen consumption, measured by vo2 max test
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Isfahan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.Mehdi Kargarfard, University of Isfahan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876627
- Sponsor's protocol ID
- 201527904IR
- Status last verified
- Aug 2016
- First submitted
- 15 Aug 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 12 Weeks of Aerobic Training Program on Erythrocyte Levels in Women With Breast Cancer After Chemotherapy
- ClinicalTrials.gov ID
- NCT02876627
- Acronym / sponsor ID
- 201527904IR
- Conditions
- Cancer, Exercise, Hemoglobins
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of IsfahanUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 24 Aug 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.
Introduction: The purpose of this study was to determine the effect of twelve weeks of aerobic exercise program on erythrocyte levels in women with breast cancer after chemotherapy.
Methods: Thirty women with breast cancer after chemotherapy of Sydalshhda hospital (aged between 47-65 years) volunteered for this study, and then randomly selected an exercise (n = 15) and control (n = 15) groups. Exercise group completed a twelve-week aerobic exercise training program consisted of three sessions per week, each session lasting 30 to 60 minutes 50 to 75 percent of their maximum heart rate reserve, while the control group were followed. Blood samples including red blood cell counts (RBC), hematocrit (HCT), hemoglobin (HB), peak oxygen consumption before and after 12 weeks of aerobic exercise were measured. For analysis of data, repeated-measures analysis of variance (ANOVA) was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast cancer | Experimental | Behavioral: Exercise trainingEffect of exercise training on breast cancer patient |
Who may qualify
- Ages
- 47 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women with breast cancer , who can do a physical, physiological and psychological test; and did not have exercise limitations due to neuromuscular and/or musculoskeletal disease; did not have any health problems that prevented maximum effort on the treadmill test.
Key exclusion criteria (1 listed)
- women under erythropoietin treatments, uncontrolled cardiovascular or pulmonary diseases, uncontrolled arrhythmias, orthopedic conditions that would limit exercise participation, refusal for randomization, or participation in aerobic exercise training within 3 months before beginning the study.
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 |
|---|---|---|
| Exercise trainingtwelve-week aerobic exercise training program consisted of three sessions per week, each session lasting 30 to 60 minutes 50 to 75 percent of their maximum heart rate reserve | Behavioural | breast cancer |
Primary outcome
effect of exercise on CBC parameters (measured by ELISA methods)
Time frame: up to 12 weeks
1 secondary outcome
effect of exercise on peak oxygen consumption, measured by vo2 max test
Time frame: up to 12 weeks
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 24 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise training in people with Cancer and Exercise, run by University of Isfahan.
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 1 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 24 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
effect of exercise on CBC parameters (measured by ELISA methods) (time frame: up to 12 weeks). 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 24 Aug 2016.