Adaptated Physical Activity in Cancerology

Study Overview
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Brief Summary
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This trial will measure the fatigue in breast cancer patients. 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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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.

Official Title
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APACAN study_Adaptated Physical Activity in Cancerology

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18 to 75 years (included) 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: Cancer other than breast cancer and / or associated with breast cancer 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm A with physical activity during the treatment<br>In the arm A, patients will realise physical activity during the treatment. Blood samples will be realised. Questionnaries will be given to the patients. | Other: physical activity<br>* Patients will realise physical activity either during their treatment, either after their treatment. They will have practise a physical activity three times per week.<br>|
| Other: Arm B with physical activity after the treatment<br>In the arm B, the physical activity will be realised after treatment. Blood samples will be realised. Questionnaries will be given to the patients. | Other: physical activity<br>* Patients will realise physical activity either during their treatment, either after their treatment. They will have practise a physical activity three times per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Fatigue, Physical activity