Breast Cancer
Conditions
Keywords
Breast cancer, Fatigue, Physical activity
Brief summary
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
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.
Interventions
OTHERphysical 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.
Sponsors
Centre Jean Perrin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between the questionnaries scores MFI 20 (specific fatigue) between baseline and end of treatment. | up to 6 months | The scores of fatigue at the end of treatment and at the inclusion will be compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QLQ-C30 | up to 6 months | Comparison of the scores of QLQ-C30 assessed at the end of the treatment and at the inclusion. |
Outcome results
None listed