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Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy (FIGHTDIGO)

Primary Purpose

Handgrip Strength Test, Sarcopenia, Digestive Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
handgrip strength test
chemotherapy
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Handgrip Strength Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with digestive cancer having a chemotherapy and/or biotherapy in the department of Reims
  • > 18 years old
  • after patient agreement
  • linked to social security system

Exclusion Criteria:

  • legal guardianship
  • < 18 years old
  • neuro-muscular issue

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    patient undergoing to chemotherapy during 6 months

    Arm Description

    Outcomes

    Primary Outcome Measures

    number of patients having at least one handgrip strength test among all hospitalized cancer patients undergoing chemotherapy
    Evaluation of handgrip test by patients
    Evaluation of handgrip test by staff (nurses, interns, students)
    number of handgrip strength test measures per patient, number of handgrip test measures compared to the number of day hospitalisations, number of patients who had all of the measures, between 50 and 100% of measures, less than 50% of measures

    Secondary Outcome Measures

    to study the association between hand grip strength test and tolerance to chemotherapy
    to follow the short term evolution of hand grip strength test during 6 months in patients undergoing chemotherapy
    to study the association between the evolution of hand grip strength test and the evolution of nutritional indices (anthropometric and biologic)

    Full Information

    First Posted
    June 2, 2016
    Last Updated
    January 5, 2018
    Sponsor
    CHU de Reims
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02797197
    Brief Title
    Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy
    Acronym
    FIGHTDIGO
    Official Title
    Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 18, 2016 (Actual)
    Primary Completion Date
    February 15, 2017 (Actual)
    Study Completion Date
    February 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CHU de Reims

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Sarcopenia is defined as a loss in skeletal muscle mass and function (strength and/or performance). There is a high prevalence in elderly and in patients with cancer. Several mechanisms are known to explain sarcopenia (inflammation, neurodegenerative process, hormonal disorders, lack of exercise, malnutrition). The consequences were analysed in several studies where sarcopenia appeared to be an independent factor of mortality, and associated with cancer-related fatigue, nosocomial infections, cardio-vascular diseases, and chemotherapy toxicities. Diagnosis is based on the measure of the muscle mass performing an abdominal computed-tomography (CT) scan, and on the measure of the muscle strength using the handgrip test with a "Jamar®" hydraulic hand dynamometer. CT scan is more invasive and less easy to reach than handgrip test. This test is used to be performing in elderly but not in cancer patients having chemotherapy. Present prospective study explored the feasibility of systematic handgrip strength testing and short-term changes in muscle strength in digestive cancer patients treated by chemotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Handgrip Strength Test, Sarcopenia, Digestive Cancer, Muscle Strength, Chemotherapy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    201 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    patient undergoing to chemotherapy during 6 months
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    handgrip strength test
    Intervention Type
    Drug
    Intervention Name(s)
    chemotherapy
    Primary Outcome Measure Information:
    Title
    number of patients having at least one handgrip strength test among all hospitalized cancer patients undergoing chemotherapy
    Time Frame
    6 months
    Title
    Evaluation of handgrip test by patients
    Time Frame
    after 3 months
    Title
    Evaluation of handgrip test by staff (nurses, interns, students)
    Time Frame
    6 months
    Title
    number of handgrip strength test measures per patient, number of handgrip test measures compared to the number of day hospitalisations, number of patients who had all of the measures, between 50 and 100% of measures, less than 50% of measures
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    to study the association between hand grip strength test and tolerance to chemotherapy
    Time Frame
    6 months
    Title
    to follow the short term evolution of hand grip strength test during 6 months in patients undergoing chemotherapy
    Time Frame
    6 months
    Title
    to study the association between the evolution of hand grip strength test and the evolution of nutritional indices (anthropometric and biologic)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with digestive cancer having a chemotherapy and/or biotherapy in the department of Reims > 18 years old after patient agreement linked to social security system Exclusion Criteria: legal guardianship < 18 years old neuro-muscular issue

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34251540
    Citation
    Perrier M, Ordan MA, Barbe C, Mazza C, Botsen D, Moreau J, Renard Y, Brasseur M, Tailliere B, Regnault P, Bertin E, Bouche O. Dynapenia in digestive cancer outpatients: association with markers of functional and nutritional status (the FIGHTDIGO study). Support Care Cancer. 2022 Jan;30(1):207-215. doi: 10.1007/s00520-021-06416-1. Epub 2021 Jul 12.
    Results Reference
    derived
    PubMed Identifier
    30286724
    Citation
    Botsen D, Ordan MA, Barbe C, Mazza C, Perrier M, Moreau J, Brasseur M, Renard Y, Tailliere B, Slimano F, Bertin E, Bouche O. Dynapenia could predict chemotherapy-induced dose-limiting neurotoxicity in digestive cancer patients. BMC Cancer. 2018 Oct 4;18(1):955. doi: 10.1186/s12885-018-4860-1.
    Results Reference
    derived

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    Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy

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