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

Sarcopenia Clinical Trial

— FIGHTDIGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797197
• Other study ID #: PO16048
• Status: Completed
• Phase: N/A
• First received: June 2, 2016
• Last updated: January 5, 2018
• Start date: May 18, 2016
• Est. completion date: February 15, 2017

Study information

• Verified date: September 2017
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy
• Digestive Cancer
• Gastrointestinal Neoplasms
• Handgrip Strength Test
• Muscle Strength
• Sarcopenia

Intervention

Procedure:
• handgrip strength test

Drug:
• chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients having at least one handgrip strength test among all hospitalized cancer patients undergoing chemotherapy		6 months
Primary	Evaluation of handgrip test by patients		after 3 months
Primary	Evaluation of handgrip test by staff (nurses, interns, students)		6 months
Primary	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	to study the association between hand grip strength test and tolerance to chemotherapy		6 months
Secondary	to follow the short term evolution of hand grip strength test during 6 months in patients undergoing chemotherapy		6 months
Secondary	to study the association between the evolution of hand grip strength test and the evolution of nutritional indices (anthropometric and biologic)		6 months