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Difficulty to include patients
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This trial will measure the fatigue in breast cancer patients.
Two groups of patients will be realised:
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.
This is an open monocentric study, randomized in two parallel arms with a waiting list.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A with physical activity during the treatment | Other | In the arm A, patients will realise physical activity during the treatment. Blood samples will be realised. Questionnaries will be given to the patients. |
|
| Arm B with physical activity after the treatment | Other | In the arm B, the physical activity will be realised after treatment. Blood samples will be realised. Questionnaries will be given to the patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical activity | Other | Patients will realise physical activity either during their treatment, either after their treatment. They will have practise a physical activity three times per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the questionnaries scores MFI 20 (specific fatigue) between baseline and end of treatment. | The scores of fatigue at the end of treatment and at the inclusion will be compared. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| QLQ-C30 | Comparison of the scores of QLQ-C30 assessed at the end of the treatment and at the inclusion. | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yves Jean Bignon, MD,PhD | Centre Jean Perrin | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |