Clinical trial NCT04391543: BIOpsychosocial Approach of the CAncer-RElated FAtigue (BIOCARE FActory)
Official title: BIOpsychosocial Approach of the CAncer-RElated FAtigue
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Le Mans Universite
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sociability status
timeFrame: 18 months
measure: Physical characteristics 1
timeFrame: 18 months
measure: Physical characteristics 2
timeFrame: 18 months
measure: Physical characteristics 3
timeFrame: 18 months
measure: Physical characteristics 4
timeFrame: 18 months
measure: Postural stability
timeFrame: 18 months
measure: Cognitive function 1
timeFrame: 18 months
measure: Cognitive function 2
timeFrame: 18 months
measure: Cognitive function 3
timeFrame: 18 months
measure: Fatigability
timeFrame: 18 months
measure: Functional cardio-respiratory capability
timeFrame: 18 months
measure: Quality of life status
timeFrame: 18 months
measure: Fatigue
timeFrame: 18 months
measure: Anxiety
timeFrame: 18 months
measure: Emotional function
timeFrame: 18 months
measure: Level of activity
timeFrame: 18 months
measure: Inflammatory status (pro-inflammatory cytokines)
timeFrame: 18 months
measure: Inflammatory status (anti inflammatory cytokine)
timeFrame: 18 months
measure: Sarcopenia 1
timeFrame: 18 months
measure: Sarcopenia 2
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Le Mans University
Study officials:
affiliation: Clinique Victor Hugo - LE MANS
name: Hugues Bourgeois, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier du Mans
name: Caroline Fonsegrive, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chartogne M, Leclercq A, Beaune B, Boyas S, Forestier C, Martin T, Thomas-Ollivier V, Landry S, Bourgeois H, Cojocarasu O, Pialoux V, Zanna O, Messonnier LA, Rahmani A, Morel B. Building a biopsychosocial model of cancer-related fatigue: the BIOCARE FActory cohort study protocol. BMC Cancer. 2021 Oct 23;21(1):1140. doi: 10.1186/s12885-021-08831-3.