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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02797197
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : January 8, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Handgrip Strength Test Sarcopenia Digestive Cancer Muscle Strength Chemotherapy Procedure: handgrip strength test Drug: chemotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : February 15, 2017
Actual Study Completion Date : February 15, 2017

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

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

Secondary Outcome Measures :
  1. to study the association between hand grip strength test and tolerance to chemotherapy [ Time Frame: 6 months ]
  2. to follow the short term evolution of hand grip strength test during 6 months in patients undergoing chemotherapy [ Time Frame: 6 months ]
  3. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CHU de Reims Identifier: NCT02797197    
Other Study ID Numbers: PO16048
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: September 2017
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases