NCT02797197

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
Last Updated

January 8, 2018

Status Verified

September 1, 2017

Enrollment Period

9 months

First QC Date

June 2, 2016

Last Update Submit

January 5, 2018

Conditions

Handgrip Strength TestSarcopeniaDigestive CancerMuscle StrengthChemotherapy

Outcome Measures

Primary Outcomes (4)

  • number of patients having at least one handgrip strength test among all hospitalized cancer patients undergoing chemotherapy

    6 months

  • Evaluation of handgrip test by patients

    after 3 months

  • Evaluation of handgrip test by staff (nurses, interns, students)

    6 months

  • 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

    6 months

Secondary Outcomes (3)

  • to study the association between hand grip strength test and tolerance to chemotherapy

    6 months

  • to follow the short term evolution of hand grip strength test during 6 months in patients undergoing chemotherapy

    6 months

  • to study the association between the evolution of hand grip strength test and the evolution of nutritional indices (anthropometric and biologic)

    6 months

Study Arms (1)

patient undergoing to chemotherapy during 6 months

EXPERIMENTAL
Procedure: handgrip strength testDrug: chemotherapy

Interventions

handgrip strength testPROCEDURE
patient undergoing to chemotherapy during 6 months
chemotherapyDRUG
patient undergoing to chemotherapy during 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 34251540DERIVED

  • 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.

    PMID: 30286724DERIVED

MeSH Terms

Conditions

SarcopeniaGastrointestinal Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 13, 2016

Study Start

May 18, 2016

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

January 8, 2018

Record last verified: 2017-09