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

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental session
Sponsored by
Le Mans Universite
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental Arm

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 22, 2020
    Last Updated
    September 17, 2020
    Sponsor
    Le Mans Universite
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04391543
    Brief Title
    BIOpsychosocial Approach of the CAncer-RElated FAtigue (BIOCARE FActory)
    Official Title
    BIOpsychosocial Approach of the CAncer-RElated FAtigue
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2021 (Anticipated)
    Primary Completion Date
    June 15, 2024 (Anticipated)
    Study Completion Date
    June 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Le Mans Universite

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Arm
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Experimental session
    Other Intervention Name(s)
    Experimental Arm
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Sociability status
    Description
    Change from baseline of a Comprehensive interview
    Time Frame
    18 months
    Title
    Physical characteristics 1
    Description
    Change from baseline of height (in meters)
    Time Frame
    18 months
    Title
    Physical characteristics 2
    Description
    Change from baseline of mass (in kilograms)
    Time Frame
    18 months
    Title
    Physical characteristics 3
    Description
    Change from baseline of fat mass (in percentage)
    Time Frame
    18 months
    Title
    Physical characteristics 4
    Description
    Change from baseline of leg volum
    Time Frame
    18 months
    Title
    Postural stability
    Description
    Change from baseline of maximum displacement speed of pressure centre at the postural stability test
    Time Frame
    18 months
    Title
    Cognitive function 1
    Description
    Change from baseline of Stroop test score (higher score means worse outcome)
    Time Frame
    18 months
    Title
    Cognitive function 2
    Description
    Change from baseline of Montreal Cognitive Assessment score (higher score means better outcome)
    Time Frame
    18 months
    Title
    Cognitive function 3
    Description
    Change from baseline of Trail Making test score (higher score means worse outcome)
    Time Frame
    18 months
    Title
    Fatigability
    Description
    Change from baseline at critical force test measurement
    Time Frame
    18 months
    Title
    Functional cardio-respiratory capability
    Description
    Change from baseline of the maximum volum of oxygen during Astrand-Rhyming test
    Time Frame
    18 months
    Title
    Quality of life status
    Description
    Change from baseline of the European Organisation for Research and Treatment of Cancer quality of life C30 questionnaire score (higher score means better outcome)
    Time Frame
    18 months
    Title
    Fatigue
    Description
    Change from baseline of the European Organisation for Research and Treatment of Cancer Fatigue questionnaire score (higher score means worse outcome)
    Time Frame
    18 months
    Title
    Anxiety
    Description
    Change from baseline of the Hospital Anxiety and Depression scale score (higher score means worse outcome)
    Time Frame
    18 months
    Title
    Emotional function
    Description
    Change from baseline of the Brief Cope test score
    Time Frame
    18 months
    Title
    Level of activity
    Description
    Change from baseline of actimetry mesurement
    Time Frame
    18 months
    Title
    Inflammatory status (pro-inflammatory cytokines)
    Description
    Change from baseline of blood inflammatory markers determined by ELISA test (pro-inflammatory cytokines : IL-6, TNFα, IL-8, IL-1β)
    Time Frame
    18 months
    Title
    Inflammatory status (anti inflammatory cytokine)
    Description
    Change from baseline of blood inflammatory markers determined by ELISA test ( anti inflammatory cytokine : IL-1ra)
    Time Frame
    18 months
    Title
    Sarcopenia 1
    Description
    Change from baseline of body masse index
    Time Frame
    18 months
    Title
    Sarcopenia 2
    Description
    Change from baseline of musculo-skeletal index measurement on the third lumbar vertebra on scanner
    Time Frame
    18 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abderrahmane Rahmani
    Phone
    2438326.6
    Ext
    +33
    Email
    abdel.rahmani@univ-lemans.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Magali Balavoine
    Phone
    241682940
    Ext
    +33
    Email
    m.balavoine@weprom.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hugues Bourgeois, MD
    Organizational Affiliation
    Clinique Victor Hugo - LE MANS
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34688272
    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.
    Results Reference
    derived

    Learn more about this trial

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

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