Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Exercise Study in Patients With Lung Cancer (POSITIVE)

This study has been completed.
Sponsor:
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
German Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01581346
First received: April 5, 2012
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

In the course of their disease patients with Non small cell lung cancer (NSCLC) often experience impaired psychological and physical functioning resulting in a reduced quality of life (QoL). The aim of the study is to explore the feasibility and the effects of an eight weeks combined muscle strength and endurance training on physical capacity and QoL.


Condition Intervention Phase
Non Small Cell Lung Cancer
Other: Exercise intervention
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pilot Study to Establish an Exercise Intervention in Patients With Lung Cancer

Resource links provided by NLM:


Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:
  • - number of patients who are adherent to the exercise intervention [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    Adherence is defined as: completion of at least two training sessions per week during minimum six weeks out of eight weeks of the intervention.


Secondary Outcome Measures:
  • - effects of the exercise intervention on psychological symptoms (e.g. quality of life) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    Quality of life will be measured by the standardized and validated questionnaire FACT-L;

  • - effects of the exercise intervention on physical symptoms (muscle strength and endurance) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    Muscle strength will be measured by hand held dynamometry and endurance by 6 Minute Walk Test


Enrollment: 40
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise intervention
Pts were instructed to train at least 5 times/ week in the inpatient setting. After discharge pts were instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks.
Other: Exercise intervention
Pts were instructed to train at least 5 times/ week in the inpatient setting. After discharge pts were instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks.

Detailed Description:

In this open, prospective, single center study 40 patients (pts) with NSCLC undergoing adjuvant or palliative chemo-/ or radiotherapy are enrolled. Physical status is assessed by using the 6 Minute Walk Test (6MWT) for endurance and by using the Handheld Dynamometer (HHDM) for strength (flexion and extension of elbow, hip and knee). Psychological performance is measured by standardized questionnaires (MFI, FACT-L, PHQ - 9). Data are collected at baseline (T0) and after the 8 weeks sports intervention (T1). Pts are instructed to train at least 5 times/ week in the inpatient setting. After discharge pts are instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks. Feasibility is defined as an adherence of two trainings per week during at least 6 weeks (out of 8 weeks of the intervention).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients
  • histological confirmed diagnosis of Non small cell lung cancer (NSCLC)
  • current treatment: chemo-and/or radiotherapy
  • age > 18y
  • Body Mass Index (BMI) > 18
  • written informed consent

Exclusion Criteria:

  • acute infection
  • immobility > 2 days
  • severe neurological impairment
  • severe cardiac impairment
  • severe pulmonal impairment
  • severe renal impairment
  • acute bleedings
  • alcohol-/drug-abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581346

Locations
Germany
Thoracic Oncology Clinic for Thoracic Diseases
Heidelberg, Germany, 69126
Sponsors and Collaborators
German Cancer Research Center
Heidelberg University
Investigators
Principal Investigator: Michael Thomas, MD Heidelberg University
  More Information

No publications provided

Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01581346     History of Changes
Other Study ID Numbers: POSITIVE_II
Study First Received: April 5, 2012
Last Updated: April 18, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by German Cancer Research Center:
NSCLC
exercise intervention
quality of life

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014