BIOpsychosocial Approach of the CAncer-RElated FAtigue (BIOCARE FActory)

Le Mans Universite

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Other: Experimental session

Study type: Interventional

Funder types: Other

Identifiers

NCT04391543

2019-A02525-52 (Other Identifier)

MIP-2019-001

Details and patient eligibility

About

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 survival. However, cancer-related fatigue is largely underestimated by patients and poorly taken into account by clinicians. One of the reasons for its poor management is a lack of knowledge of the underlying mechanisms and risk factors.

Although a multiplicity of factors are associated with the appearance of cancer-related fatigue, we do not know their respective share, nor the nature of their interactions. The phenomenon studied reveals complex and systemic interactions between the biological, psychological and social dimensions. Recent systematic reviews clearly identify 2 locks currently preventing a better understanding of the mechanisms of cancer-related fatigue: i) lack of longitudinal studies, ii) lack of interdisciplinary studies. It is precisely these two challenges that the BIOCARE FActory project wishes to respond to.

Enrollment: 86 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Experimental Arm

Experimental group

Description:

4 experimental session (baseline, after treatment, 6 month post treatment and 12 months post treatment) with : comprehensive interview cognitive tests anthropometric measures postural balance test critical force test Astrand-Ryhming test self-questionnaire (QLQ-C30, FA12, Brief Cope et Hospital Anxiety and Depression Scale) actimetry clinical and biological characteristics determination of inflammatory markers skeletal muscle index

Treatment:

Other: Experimental session