Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer

January 5, 2017 updated by: Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer.

Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, its mechanisms ans its relation with muscle function and effort tolerance are still unknown.

Aim: To explore muscle function, signaling pathways and its relationship to impaired functional capacity of patients with non-small-cell lung cancer(NSCLC); depending of whether they have cachexic state at diagnosis.

Methods: This study will be conducted at the Institut universitaire de cardiologie et de pneumologie de Québec. 56 patients newly diagnosed of NSCLC will be recruited and separated whether or not they have a cachexic state. The evaluation will need two visits separated by 5 days.

During the evaluation the following tests will be done:

  • Anthropometric measures
  • Level of daily physical activity
  • Pulmonary function test
  • Maximal incremental cardiopulmonary exercise test on ergocycle
  • Endurance test on ergocycle
  • Muscle function tests
  • Magnetic stimulation
  • Quadriceps biopsy

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
        • Institut universitaire de Cardiologie et de Pneumologie de Quebec
        • Contact:
        • Principal Investigator:
          • Didier Saey, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with NSCLC

Description

Inclusion Criteria:

  • Men and women with a primary lung cancer diagnosis

Exclusion Criteria:

  • Already have undertaken surgery, chemotherapy or radiotherapy treatment
  • Having an other cancer in the last five years
  • Taking anticoagulation therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Lung cancer patient with cachexia
Muscle lumbar area < 55cm2/m2 for men and < 39 cm2/m2 for women
Lung cancer patients without cachexia
Muscle lumbar area over 55cm2/m2 for men and 39 cm2/m2 for women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal quadriceps strength
Time Frame: 1 day (at the time of the diagnosis before any treatment)
1 day (at the time of the diagnosis before any treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Exercise capacity
Time Frame: 1 day (at the time of the diagnosis before any treatment)
1 day (at the time of the diagnosis before any treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Investigators

  • Principal Investigator: Didier Saey, PhD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (Estimate)

June 25, 2013

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20878

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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