Supervised Exercise, Sleep in Patients With Non Metastatic Breast Cancer (FATSOMCAN)

Centre Hospitalier Universitaire de Besancon

Status

Unknown

Conditions

Breast Cancer

Treatments

Other: Physical activity

Study type

Interventional

Funder types

Other

Identifiers

NCT04867096

2020/482

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged 18 to 65
Patients with non-metastatic breast cancer undergoing chemotherapy
Patients with insomnia
Certificate of non-contraindication to the practice of physical activity
Women who have been postmenopausal for at least 24 months, surgically sterilized, or, for women of childbearing potential, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)
Signature of informed consent to participate indicating that the subject has understood the purpose and procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
Affiliation to a French social security scheme or beneficiary of such a scheme.

Exclusion criteria

Patients treated with melatonin or taking hypnotics
Patients with metastases
Oxygen saturation at rest (SaO2) ≤ 92%
Patients without insomnia and / or sleep disorders
Autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis)
Symptomatic osteoarthritis, cardiovascular disease (angina pectoris or uncontrolled hypertension) or lung disease (chronic obstructive pulmonary disease)
Patients suffering from malnutrition (BMI <18 kg.m-2) or weight loss> 10% during the previous 3 months
Patients with psychiatric or cognitive disorders deemed unsuitable for physical activity
Pregnant or breastfeeding women
Legal incapacity or limited legal capacity
Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
Subject without health insurance
Subject being in the period of exclusion from another study or provided for by the "national file of volunteers".