Breast Cancer
Conditions
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.
Interventions
OTHERExperimental 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
Sponsors
Le Mans Universite
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sociability status | 18 months | Change from baseline of a Comprehensive interview |
| Physical characteristics 1 | 18 months | Change from baseline of height (in meters) |
| Physical characteristics 2 | 18 months | Change from baseline of mass (in kilograms) |
| Physical characteristics 3 | 18 months | Change from baseline of fat mass (in percentage) |
| Physical characteristics 4 | 18 months | Change from baseline of leg volum |
| Postural stability | 18 months | Change from baseline of maximum displacement speed of pressure centre at the postural stability test |
| Cognitive function 1 | 18 months | Change from baseline of Stroop test score (higher score means worse outcome) |
| Cognitive function 2 | 18 months | Change from baseline of Montreal Cognitive Assessment score (higher score means better outcome) |
| Cognitive function 3 | 18 months | Change from baseline of Trail Making test score (higher score means worse outcome) |
| Fatigability | 18 months | Change from baseline at critical force test measurement |
| Functional cardio-respiratory capability | 18 months | Change from baseline of the maximum volum of oxygen during Astrand-Rhyming test |
| Quality of life status | 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) |
| Fatigue | 18 months | Change from baseline of the European Organisation for Research and Treatment of Cancer Fatigue questionnaire score (higher score means worse outcome) |
| Anxiety | 18 months | Change from baseline of the Hospital Anxiety and Depression scale score (higher score means worse outcome) |
| Emotional function | 18 months | Change from baseline of the Brief Cope test score |
| Level of activity | 18 months | Change from baseline of actimetry mesurement |
| Inflammatory status (pro-inflammatory cytokines) | 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) | 18 months | Change from baseline of blood inflammatory markers determined by ELISA test ( anti inflammatory cytokine : IL-1ra) |
| Sarcopenia 1 | 18 months | Change from baseline of body masse index |
| Sarcopenia 2 | 18 months | Change from baseline of musculo-skeletal index measurement on the third lumbar vertebra on scanner |
Countries
France
Outcome results
None listed