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

Breast Cancer Clinical Trial

Official title:

BIOpsychosocial Approach of the CAncer-RElated FAtigue

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04391543
• Other study ID #: MIP-2019-001
• Secondary ID: 2019-A02525-52
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: February 15, 2025

Study information

• Verified date: April 2024
• Source: Le Mans Universite
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: February 15, 2025
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Fatigue

Intervention

Other:
• Experimental session
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

Locations

Country	Name	City	State
France	Le Mans University	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Le Mans Universite

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sociability status	Change from baseline of a Comprehensive interview	18 months
Primary	Physical characteristics 1	Change from baseline of height (in meters)	18 months
Primary	Physical characteristics 2	Change from baseline of mass (in kilograms)	18 months
Primary	Physical characteristics 3	Change from baseline of fat mass (in percentage)	18 months
Primary	Physical characteristics 4	Change from baseline of leg volum	18 months
Primary	Postural stability	Change from baseline of maximum displacement speed of pressure centre at the postural stability test	18 months
Primary	Cognitive function 1	Change from baseline of Stroop test score (higher score means worse outcome)	18 months
Primary	Cognitive function 2	Change from baseline of Montreal Cognitive Assessment score (higher score means better outcome)	18 months
Primary	Cognitive function 3	Change from baseline of Trail Making test score (higher score means worse outcome)	18 months
Primary	Fatigability	Change from baseline at critical force test measurement	18 months
Primary	Functional cardio-respiratory capability	Change from baseline of the maximum volum of oxygen during Astrand-Rhyming test	18 months
Primary	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
Primary	Fatigue	Change from baseline of the European Organisation for Research and Treatment of Cancer Fatigue questionnaire score (higher score means worse outcome)	18 months
Primary	Anxiety	Change from baseline of the Hospital Anxiety and Depression scale score (higher score means worse outcome)	18 months
Primary	Emotional function	Change from baseline of the Brief Cope test score	18 months
Primary	Level of activity	Change from baseline of actimetry mesurement	18 months
Primary	Inflammatory status (pro-inflammatory cytokines)	Change from baseline of blood inflammatory markers determined by ELISA test (pro-inflammatory cytokines : IL-6, TNFa, IL-8, IL-1ß)	18 months
Primary	Inflammatory status (anti inflammatory cytokine)	Change from baseline of blood inflammatory markers determined by ELISA test ( anti inflammatory cytokine : IL-1ra)	18 months
Primary	Sarcopenia 1	Change from baseline of body masse index	18 months
Primary	Sarcopenia 2	Change from baseline of musculo-skeletal index measurement on the third lumbar vertebra on scanner	18 months