Supervised Exercise, Sleep in Patients With Non Metastatic Breast Cancer

NCT ID: NCT04867096

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2023-08-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Physical activity intervention

Arm A : "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: OTHER

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.

Control

Arm B : "standard oncologic care".

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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".

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Besançon

Besançon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

MOUGIN-GUILLAUME Fabienne

Role: CONTACT

fabienne.mougin-guillaume@univ-fcomte.fr

0363082585

Facility Contacts

Fabienne MOUGIN-GUILLAUME

Role: primary

fabienne.mougin-guillaume@univ-fcomte.fr

References

Drozd C, Curtit E, Jacquinot Q, Marquine C, Mansi L, Chaigneau L, Dobi E, Viot J, Meynard G, Paillard MJ, Goujon M, Roux P, Vernerey D, Gillet V, Bourdin H, Galli S, Meneveau N, Mougin F. A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN study. BMC Cancer. 2023 May 17;23(1):449. doi: 10.1186/s12885-023-10902-6.

Reference Type: DERIVED

PMID: 37198562 (View on PubMed)

Other Identifiers

2020/482

Identifier Type: -

Identifier Source: org_study_id