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

NCT04391543 | Active Not Recruiting

• 2 other identifiers: MIP-2019-0012019-A02525-52
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (20)

• Sociability status

  Change from baseline of a Comprehensive interview

  18 months

• Physical characteristics 1

  Change from baseline of height (in meters)

  18 months

• Physical characteristics 2

  Change from baseline of mass (in kilograms)

  18 months

• Physical characteristics 3

  Change from baseline of fat mass (in percentage)

  18 months

• Physical characteristics 4

  Change from baseline of leg volum

  18 months

• Postural stability

  Change from baseline of maximum displacement speed of pressure centre at the postural stability test

  18 months

• Cognitive function 1

  Change from baseline of Stroop test score (higher score means worse outcome)

  18 months

• Cognitive function 2

  Change from baseline of Montreal Cognitive Assessment score (higher score means better outcome)

  18 months

• Cognitive function 3

  Change from baseline of Trail Making test score (higher score means worse outcome)

  18 months

• Fatigability

  Change from baseline at critical force test measurement

  18 months

• Functional cardio-respiratory capability

  Change from baseline of the maximum volum of oxygen during Astrand-Rhyming test

  18 months

• Quality of life status

  Change from baseline of the European Organisation for Research and Treatment of Cancer quality of life C30 questionnaire score (higher score means better outcome)

  18 months

• Fatigue

  Change from baseline of the European Organisation for Research and Treatment of Cancer Fatigue questionnaire score (higher score means worse outcome)

  18 months

• Anxiety

  Change from baseline of the Hospital Anxiety and Depression scale score (higher score means worse outcome)

  18 months

• Emotional function

  Change from baseline of the Brief Cope test score

  18 months

• Level of activity

  Change from baseline of actimetry mesurement

  18 months

• Inflammatory status (pro-inflammatory cytokines)

  Change from baseline of blood inflammatory markers determined by ELISA test (pro-inflammatory cytokines : IL-6, TNFα, IL-8, IL-1β)

  18 months

• Inflammatory status (anti inflammatory cytokine)

  Change from baseline of blood inflammatory markers determined by ELISA test ( anti inflammatory cytokine : IL-1ra)

  18 months

• Sarcopenia 1

  Change from baseline of body masse index

  18 months

• Sarcopenia 2

  Change from baseline of musculo-skeletal index measurement on the third lumbar vertebra on scanner

  18 months

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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

Other: Experimental session

Interventions

Experimental session OTHER

* 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

Also known as: Experimental Arm

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient followed at the Victor Hugo Clinic, Le Mans.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Le Mans Universite: lead

Study Sites (1)

Le Mans University

Le Mans, 72085, France

Location

Related Publications (3)

• Leclercq A, Chatrenet A, Bourgeois H, Cojocarasu O, Mathie C, Martin T, Rahmani A, Morel B. Multidisciplinary analysis of cancer-related fatigue at the time of diagnosis: preliminary results of the BIOCARE FActory cohort. Support Care Cancer. 2024 Apr 30;32(5):319. doi: 10.1007/s00520-024-08520-4.

  PMID: 38689167 DERIVED

• Chartogne M, Rahmani A, Landry S, Morel B. Comparison of neuromuscular fatigability amplitude and etiologies between fatigued and non-fatigued cancer patients. Eur J Appl Physiol. 2024 Apr;124(4):1175-1184. doi: 10.1007/s00421-023-05347-5. Epub 2023 Nov 12.

  PMID: 37952231 DERIVED

• 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.

  PMID: 34688272 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Hugues Bourgeois, MD

  Clinique Victor Hugo - LE MANS

  PRINCIPAL INVESTIGATOR

• Caroline Fonsegrive, MD

  Centre Hospitalier du Mans

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: May 18, 2020
• Study Start: November 15, 2021
• Primary Completion: August 15, 2023
• Study Completion: February 15, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)