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

Sponsor
CHU de Reims (Other)
Overall Status
Completed
CT.gov ID
NCT02797197
Collaborator
(none)
201
1
9

Study Details

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 "JamarĀ®" 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
201 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy
Actual Study Start Date :
May 18, 2016
Actual Primary Completion Date :
Feb 15, 2017
Actual Study Completion Date :
Feb 15, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: patient undergoing to chemotherapy during 6 months

Procedure: handgrip strength test

Drug: chemotherapy

Outcome Measures

Primary Outcome Measures

  1. number of patients having at least one handgrip strength test among all hospitalized cancer patients undergoing chemotherapy [6 months]

  2. Evaluation of handgrip test by patients [after 3 months]

  3. Evaluation of handgrip test by staff (nurses, interns, students) [6 months]

  4. 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

  1. to study the association between hand grip strength test and tolerance to chemotherapy [6 months]

  2. to follow the short term evolution of hand grip strength test during 6 months in patients undergoing chemotherapy [6 months]

  3. to study the association between the evolution of hand grip strength test and the evolution of nutritional indices (anthropometric and biologic) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CHU de Reims
ClinicalTrials.gov Identifier:
NCT02797197
Other Study ID Numbers:
  • PO16048
First Posted:
Jun 13, 2016
Last Update Posted:
Jan 8, 2018
Last Verified:
Sep 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 8, 2018