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Insomnia affects about 60% of the patients treated with radio-chemotherapy, a percentage twice higher compared to that observed in the general population. This sleep disorder increases cancer-related fatigue (CRF), the side effect most often reported by patients. Conversely, it is well accepted that adapted physical activity (APA) improves tolerance to treatment, decreases the risk of recurrence, increases survival, and reduces CRF. The present study aims to evaluate, in non-metastatic breast cancer patients, the composition and architecture of sleep by ambulatory polysomnography and to verify the effects of an APA rehabilitation program (3 times a week during 12 weeks), on the quality and quantity of sleep, daytime sleepiness. The biological markers: melatonin and body temperature will be studied to better understand the chronobiological mechanisms of the sleep-wake rhythm. Finally, the physiological responses to exercise, pain, CRF and finally quality of life will be studied at the beginning, at the end of the program and at a distance from it. Improved sleep-wake rhythm by a physical activity may reduce CRF, prevent recurrence and comorbidities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity intervention | Experimental | Arm A : "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months. |
|
| Control | No Intervention | Arm B : "standard oncologic care". |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity | Other | Patients in arm A (interventional) will carry out a physical activity intervention during 3 months. Patients should perform an interval training program on cycle-ergometer during 3 sessions per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Total sleep time at 6 months | Evaluated with polysomnography | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline quality of sleep at 6 months | Evaluated with actimetry | 6 months |
| Change from baseline Score of fatigue at 6 months | Evaluated with questionnaire Multidimensional Fatigue Inventory (score between 20 to 100) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MOUGIN-GUILLAUME Fabienne | Contact | 0363082585 | fabienne.mougin-guillaume@univ-fcomte.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besançon | Recruiting | Besançon | 25000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41746533 | Derived | Drozd C, Curtit E, Jacquinot Q, Roux P, Paget-Bailly S, Gillet V, Meneveau N, Mougin F. Effect of a supervised intermittent exercise program on insomnia in breast cancer patients undergoing chemotherapy. Breast Cancer Res Treat. 2026 Feb 26;216(2):20. doi: 10.1007/s10549-026-07923-7. | |
| 37198562 | Derived | Drozd C, Curtit E, Jacquinot Q, Marquine C, Mansi L, Chaigneau L, Dobi E, Viot J, Meynard G, Paillard MJ, Goujon M, Roux P, Vernerey D, Gillet V, Bourdin H, Galli S, Meneveau N, Mougin F. A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN study. BMC Cancer. 2023 May 17;23(1):449. doi: 10.1186/s12885-023-10902-6. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| 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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| 6 months |
| Change from baseline body composition at 3 months | Evaluated bioimpedance BMI in Kg/m2 | 3 months. |
| Score of pain | Evaluated by questionnaire Brief Pain Inventory-Short Form (score between 15 to 150) | Baseline (T0) , 3 months (T3). |
| Inflammatory responses | Evaluated with enzyme-linked immunosorbent assay (ELISA) | Baseline (T0), 3 months (T3). |
| Level of physical activity | Evaluated with smartwatch withings with number of step | Baseline (T0), 3 months (T3), 6 months (T6). |
| Basic respiratory functional exploration | Evaluated by pneumotachography (Sensors Medics MSE, USA) for the evaluation of bronchial volumes and flows. | Baseline (T0), 3 months (T3). |
| Level of anxiety | Evaluated by questionnaire Hospital Anxiety and Depression scale (under 7 to more than 11) | Baseline (T0), 3 months (T3), 6 months (T6). |
| Concentration of Melatonin | Evaluated by saliva samples | Baseline (T0), 3 months (T3), 6 months (T6). |
| Body temperature | Evaluated by thermobuttons | Baseline (T0), 3 months (T3), 6 months (T6). |
| D017437 |
| Skin and Connective Tissue Diseases |