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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
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.
CHU Besançon
Besançon, France
RECRUITINGChange from baseline Total sleep time at 6 months
Evaluated with polysomnography
Time frame: 6 months
Change from baseline quality of sleep at 6 months
Evaluated with actimetry
Time frame: 6 months
Change from baseline Score of fatigue at 6 months
Evaluated with questionnaire Multidimensional Fatigue Inventory (score between 20 to 100)
Time frame: 6 months
Change from baseline body composition at 3 months
Evaluated bioimpedance BMI in Kg/m2
Time frame: 3 months.
Score of pain
Evaluated by questionnaire Brief Pain Inventory-Short Form (score between 15 to 150)
Time frame: Baseline (T0) , 3 months (T3).
Inflammatory responses
Evaluated with enzyme-linked immunosorbent assay (ELISA)
Time frame: Baseline (T0), 3 months (T3).
Level of physical activity
Evaluated with smartwatch withings with number of step
Time frame: 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.
Time frame: Baseline (T0), 3 months (T3).
Level of anxiety
Evaluated by questionnaire Hospital Anxiety and Depression scale (under 7 to more than 11)
Time frame: Baseline (T0), 3 months (T3), 6 months (T6).
Concentration of Melatonin
Evaluated by saliva samples
Time frame: Baseline (T0), 3 months (T3), 6 months (T6).
Body temperature
Evaluated by thermobuttons
Time frame: Baseline (T0), 3 months (T3), 6 months (T6).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.