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
About this trial
This is an interventional other trial for Handgrip Strength Test
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
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
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
Learn more about this trial
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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