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

January 5, 2018 updated by: CHU de Reims

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient undergoing to chemotherapy during 6 months
Drug: chemotherapy
Procedure: handgrip strength test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of patients having at least one handgrip strength test among all hospitalized cancer patients undergoing chemotherapy
Time Frame: 6 months
6 months
Evaluation of handgrip test by patients
Time Frame: after 3 months
after 3 months
Evaluation of handgrip test by staff (nurses, interns, students)
Time Frame: 6 months
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
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
to study the association between hand grip strength test and tolerance to chemotherapy
Time Frame: 6 months
6 months
to follow the short term evolution of hand grip strength test during 6 months in patients undergoing chemotherapy
Time Frame: 6 months
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2016

Primary Completion (Actual)

February 15, 2017

Study Completion (Actual)

February 15, 2017

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Actual)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO16048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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