Supervised Exercise, Sleep in Patients With Non Metastatic Breast Cancer

NCT04867096 | Unknown

• 1 other identifier: 2020/482
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline Total sleep time at 6 months

  Evaluated with polysomnography

  6 months

Secondary Outcomes (10)

• Change from baseline quality of sleep at 6 months

  6 months

• Change from baseline Score of fatigue at 6 months

  6 months

• Change from baseline body composition at 3 months

  3 months.

• Score of pain

  Baseline (T0) , 3 months (T3).

• Inflammatory responses

  Baseline (T0), 3 months (T3).

Study Arms (2)

Physical activity intervention

EXPERIMENTAL

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

Other: Physical activity

Control

NO INTERVENTION

Arm B : "standard oncologic care".

Interventions

Physical activity 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.

Physical activity intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Besançon

Besançon, 25000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 37198562 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

MOUGIN-GUILLAUME Fabienne

CONTACT

0363082585; fabienne.mougin-guillaume@univ-fcomte.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 30, 2021
• Study Start: April 8, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)