BIOpsychosocial Approach of the CAncer-RElated FAtigue
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Physical characteristics 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Physical characteristics 1
Time Frame: 18 months
Change from baseline of height (in meters)
Physical characteristics 2
Time Frame: 18 months
Change from baseline of mass (in kilograms)
Physical characteristics 4
Time Frame: 18 months
Change from baseline of leg volum
Cognitive function 2
Time Frame: 18 months
Change from baseline of Montreal Cognitive Assessment score (higher score means better outcome)
Fatigability
Time Frame: 18 months
Change from baseline at critical force test measurement
Functional cardio-respiratory capability
Time Frame: 18 months
Change from baseline of the maximum volum of oxygen during Astrand-Rhyming test
Sarcopenia 1
Time Frame: 18 months
Change from baseline of body masse index
Quality of life status
Time Frame: 18 months
Change from baseline of the European Organisation for Research and Treatment of Cancer quality of life C30 questionnaire score (higher score means better outcome)
Sociability status
Time Frame: 18 months
Change from baseline of a Comprehensive interview
Fatigue
Time Frame: 18 months
Change from baseline of the European Organisation for Research and Treatment of Cancer Fatigue questionnaire score (higher score means worse outcome)
Postural stability
Time Frame: 18 months
Change from baseline of maximum displacement speed of pressure centre at the postural stability test
Physical characteristics 3
Time Frame: 18 months
Change from baseline of fat mass (in percentage)
Cognitive function 3
Time Frame: 18 months
Change from baseline of Trail Making test score (higher score means worse outcome)
Sarcopenia 2
Time Frame: 18 months
Change from baseline of musculo-skeletal index measurement on the third lumbar vertebra on scanner
Cognitive function 1
Time Frame: 18 months
Change from baseline of Stroop test score (higher score means worse outcome)
Anxiety
Time Frame: 18 months
Change from baseline of the Hospital Anxiety and Depression scale score (higher score means worse outcome)
Emotional function
Time Frame: 18 months
Change from baseline of the Brief Cope test score
Level of activity
Time Frame: 18 months
Change from baseline of actimetry mesurement
Inflammatory status (pro-inflammatory cytokines)
Time Frame: 18 months
Change from baseline of blood inflammatory markers determined by ELISA test (pro-inflammatory cytokines : IL-6, TNFα, IL-8, IL-1β)
Inflammatory status (anti inflammatory cytokine)
Time Frame: 18 months
Change from baseline of blood inflammatory markers determined by ELISA test ( anti inflammatory cytokine : IL-1ra)
Secondary Outcomes
No secondary outcomes reported