Status:
ACTIVE_NOT_RECRUITING
BIOpsychosocial Approach of the CAncer-RElated FAtigue (BIOCARE FActory)
Lead Sponsor:
Le Mans Universite
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
One of the most common and stressful side effects of the disease and associated treatments is cancer-related fatigue. It deeply disrupts quality of life and can have a negative impact on patient survi...
Eligibility Criteria
Inclusion
- Patient followed at the Victor Hugo Clinic, Le Mans.
- Patients aged \>or= 18 and \< 80 years old at the time of inclusion
- Patients with a histologically proven primary breast cancer from stage I to IIIc
- Naive patient of anti-cancer treatment for this cancer
- Agreement to participate in the study by written, informed and signed consent of the patient
- Affiliated patients or beneficiaries of a social security scheme
- ECOG Performance Status score ≤ 2
Exclusion
- Comorbidity which can explain the symptoms of fatigue (Long-term illness other than cancer, chronic fatigue syndrome)
- Breathing difficulties requiring the use of respiratory assistance
- Signs of polyneuropathy, amyotrophy or myasthenic syndrome
- Contraindications to physical exercise linked to heart failure.
- Treatment based on psychostimulants, psychotropics, antidepressants, antiepileptics or benzodiazepines for more than 3 months at the time of the study
- Presence or history of psychosis, bipolarity or severe depression
- History of stroke
- History of chronic fatigue
- History of musculoskeletal disorders of the lower limbs
- Pregnancy, breastfeeding
- Patient unable to undergo protocol monitoring for psychological, social, family or geographic reasons
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2025
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04391543
Start Date
November 15 2021
End Date
February 15 2025
Last Update
April 9 2024
Active Locations (1)
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1
Le Mans University
Le Mans, France, 72085