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

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

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 Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Physical activity

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MOUGIN-GUILLAUME Fabienne; Phone Number: 0363082585; Email: fabienne.mougin-guillaume@univ-fcomte.fr

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • CHU Besançon
    • Contact: Fabienne MOUGIN-GUILLAUME; Email: fabienne.mougin-guillaume@univ-fcomte.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Physical activity intervention; Arm A : "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months.	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.
NO_INTERVENTION: Control; Arm B : "standard oncologic care".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Total sleep time at 6 months	Evaluated with polysomnography	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline quality of sleep at 6 months	Evaluated with actimetry	6 months
Change from baseline Score of fatigue at 6 months	Evaluated with questionnaire Multidimensional Fatigue Inventory (score between 20 to 100)	6 months
Change from baseline body composition at 3 months	Evaluated bioimpedance BMI in Kg/m2	3 months.
Score of pain	Evaluated by questionnaire Brief Pain Inventory-Short Form (score between 15 to 150)	Baseline (T0) , 3 months (T3).
Inflammatory responses	Evaluated with enzyme-linked immunosorbent assay (ELISA)	Baseline (T0), 3 months (T3).
Level of physical activity	Evaluated with smartwatch withings with number of step	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.	Baseline (T0), 3 months (T3).
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).
Concentration of Melatonin	Evaluated by saliva samples	Baseline (T0), 3 months (T3), 6 months (T6).
Body temperature	Evaluated by thermobuttons	Baseline (T0), 3 months (T3), 6 months (T6).

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2021
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (ACTUAL): April 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2020/482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No