Supervised Exercise, Sleep in Patients With Non Metastatic Breast Cancer

Breast Cancer Clinical Trial

— FATSOMCAN  

Official title:

Effects of a Supervised Exercise on Sleep in Patients With Non Metastatic Breast Cancer During Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04867096
• Other study ID #: 2020/482
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2021
• Est. completion date: August 2023

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: MOUGIN-GUILLAUME Fabienne
• Phone: 0363082585
• Email: fabienne.mougin-guillaume[@]univ-fcomte.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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".

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Physical activity
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.

Locations

Country	Name	City	State
France	CHU Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Total sleep time at 6 months	Evaluated with polysomnography	6 months
Secondary	Change from baseline quality of sleep at 6 months	Evaluated with actimetry	6 months
Secondary	Change from baseline Score of fatigue at 6 months	Evaluated with questionnaire Multidimensional Fatigue Inventory (score between 20 to 100)	6 months
Secondary	Change from baseline body composition at 3 months	Evaluated bioimpedance BMI in Kg/m2	3 months.
Secondary	Score of pain	Evaluated by questionnaire Brief Pain Inventory-Short Form (score between 15 to 150)	Baseline (T0) , 3 months (T3).
Secondary	Inflammatory responses	Evaluated with enzyme-linked immunosorbent assay (ELISA)	Baseline (T0), 3 months (T3).
Secondary	Level of physical activity	Evaluated with smartwatch withings with number of step	Baseline (T0), 3 months (T3), 6 months (T6).
Secondary	Basic respiratory functional exploration	Evaluated by pneumotachography (Sensors Medics MSE, USA) for the evaluation of bronchial volumes and flows.	Baseline (T0), 3 months (T3).
Secondary	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).
Secondary	Concentration of Melatonin	Evaluated by saliva samples	Baseline (T0), 3 months (T3), 6 months (T6).
Secondary	Body temperature	Evaluated by thermobuttons	Baseline (T0), 3 months (T3), 6 months (T6).