Clinical trial NCT02797197: Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy
Official title: Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Handgrip Strength Test
Sarcopenia
Digestive Cancer
Muscle Strength
Chemotherapy
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: number of patients having at least one handgrip strength test among all hospitalized cancer patients undergoing chemotherapy
timeFrame: 6 months
measure: Evaluation of handgrip test by patients
timeFrame: after 3 months
measure: Evaluation of handgrip test by staff (nurses, interns, students)
timeFrame: 6 months
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: to study the association between hand grip strength test and tolerance to chemotherapy
timeFrame: 6 months
measure: to follow the short term evolution of hand grip strength test during 6 months in patients undergoing chemotherapy
timeFrame: 6 months
measure: to study the association between the evolution of hand grip strength test and the evolution of nutritional indices (anthropometric and biologic)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Perrier M, Ordan MA, Barbe C, Mazza C, Botsen D, Moreau J, Renard Y, Brasseur M, Tailliere B, Regnault P, Bertin E, Bouche O. Dynapenia in digestive cancer outpatients: association with markers of functional and nutritional status (the FIGHTDIGO study). Support Care Cancer. 2022 Jan;30(1):207-215. doi: 10.1007/s00520-021-06416-1. Epub 2021 Jul 12.
citation: Botsen D, Ordan MA, Barbe C, Mazza C, Perrier M, Moreau J, Brasseur M, Renard Y, Tailliere B, Slimano F, Bertin E, Bouche O. Dynapenia could predict chemotherapy-induced dose-limiting neurotoxicity in digestive cancer patients. BMC Cancer. 2018 Oct 4;18(1):955. doi: 10.1186/s12885-018-4860-1.