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NCT Number: NCT02797197

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

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.

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Key information

Conditions

Handgrip Strength Test Atrophy Chemotherapy Digestive Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Muscle Strength Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

handgrip strength test

Procedure

Chemotherapy

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: FIGHTDIGO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 13, 2016
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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