Clinical trial NCT04867096: Supervised Exercise, Sleep in Patients With Non Metastatic Breast Cancer
Official title: Effects of a Supervised Exercise on Sleep in Patients With Non Metastatic Breast Cancer During Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility criteria: 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".

Primary outcomes:
measure: Change from baseline Total sleep time at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline quality of sleep at 6 months
timeFrame: 6 months
measure: Change from baseline Score of fatigue at 6 months
timeFrame: 6 months
measure: Change from baseline body composition at 3 months
timeFrame: 3 months.
measure: Score of pain
timeFrame: Baseline (T0) , 3 months (T3).
measure: Inflammatory responses
timeFrame: Baseline (T0), 3 months (T3).
measure: Level of physical activity
timeFrame: Baseline (T0), 3 months (T3), 6 months (T6).
measure: Basic respiratory functional exploration
timeFrame: Baseline (T0), 3 months (T3).
measure: Level of anxiety
timeFrame: Baseline (T0), 3 months (T3), 6 months (T6).
measure: Concentration of Melatonin
timeFrame: Baseline (T0), 3 months (T3), 6 months (T6).
measure: Body temperature
timeFrame: Baseline (T0), 3 months (T3), 6 months (T6).
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
References: