Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2014-09-30
2015-04-30
Brief Summary
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Two groups of patients will be realised:
* Arm A: Physical activity during treatment
* Arm B: No physical activity during treatment but after
The aim of the study is to decrease fatigue, with adequate physical activity, in primary breast cancer patients who receive a treatment for their pathology.
Detailed Description
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The duration of the physical activty will vary according to the duration of the treatment: from 2 to 6 months.
Several questionnaries (fatigue, quality of life, ...) will be given to patients at the inclusion, at the end of the period of treatment and 3 to 6 months after the end of treatment.
One hundred patients are necessary in this study (fifty in each arm). We expect to a stability of the fatigue in Arm A compared to an increase of the fatigue in arm B.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Arm A with physical activity during the treatment
In the arm A, patients will realise physical activity during the treatment. Blood samples will be realised. Questionnaries will be given to the patients.
physical activity
Patients will realise physical activity either during their treatment, either after their treatment. They will have practise a physical activity three times per week.
Arm B with physical activity after the treatment
In the arm B, the physical activity will be realised after treatment. Blood samples will be realised. Questionnaries will be given to the patients.
physical activity
Patients will realise physical activity either during their treatment, either after their treatment. They will have practise a physical activity three times per week.
Interventions
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physical activity
Patients will realise physical activity either during their treatment, either after their treatment. They will have practise a physical activity three times per week.
Eligibility Criteria
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Inclusion Criteria
* Patient with a breast tumor, regardless of the stage and size (except metastatic patients)
* Patient with a local recurrence of breast cancer
* Patient with a second non-metastatic breast cancer
* Breast cancer treated, regardless of the surgery, at least by radiotherapy, chemotherapy (neoadjuvant or adjuvant) +/- targeted therapy
* A mandatory social security affiliation.
* Obtaining informed consent in writing, signed and dated.
* Medical certificate of fitness to practice physical (issued by the medical oncologist)
Exclusion Criteria
* Metastatic Cancer
* in case of surgery before treatment, delay before beginning treatment inferior to 1 month post-surgery
* Men
* Woman pregnant
* Patient with cognitive or psychiatric disorders
* Patients suffering from disability
* Significant alterations in nutritional status (malnutrition with BMI \<19, obese with BMI\> 40, BMI)
* Cardiac contraindication to physical activity
* Knowledge and understanding of the French language enough not to learn the correct way of self-administered questionnaires or respond to questioning
* Participation in another clinical study with a similar objective
* Inability to reach the centers where physical activity takes place
18 Years
75 Years
FEMALE
No
Sponsors
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Centre Jean Perrin
OTHER
Responsible Party
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Principal Investigators
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Yves Jean Bignon, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Jean Perrin
Other Identifiers
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2014-A00091-46
Identifier Type: -
Identifier Source: org_study_id