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

Not Applicable

Completed

• Conditions: Handgrip Strength Test; Digestive Cancer; Sarcopenia; Muscle Strength; Chemotherapy
• Interventions: Procedure: handgrip strength test; Drug: chemotherapy

• Registration Number: NCT02797197
• Lead Sponsor: CHU de Reims

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-18
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-13
• Primary Completion: 2017-02-15
• Study Completion: 2017-02-15
• Status Verified: 2017-09
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient undergoing to chemotherapy during 6 months	handgrip strength test	-
patient undergoing to chemotherapy during 6 months	chemotherapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
to study the association between the evolution of hand grip strength test and the evolution of nutritional indices (anthropometric and biologic)	6 months
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