Status:
UNKNOWN
Supervised Exercise, Sleep in Patients With Non Metastatic Breast Cancer
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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".
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04867096
Start Date
April 8 2021
End Date
August 1 2023
Last Update
June 1 2022
Active Locations (1)
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1
CHU Besançon
Besançon, France, 25000