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Resistance Training in Radically Treated Respiratory Cancer Patients: a Prospective Randomized Multicenter Study


N/A
18 Years
80 Years
Open (Enrolling)
Both
Respiratory Cancer

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Trial Information

Resistance Training in Radically Treated Respiratory Cancer Patients: a Prospective Randomized Multicenter Study


Inclusion Criteria:



- Patients with non-small cell or small cell lung cancer or mesothelioma candidate for
radical treatment

- either by surgical resection with or without perioperative chemotherapy

- or by thoracic radiotherapy with or without chemotherapy

- Between 18 and 80 years of age

- Written informed consent

Supplementary criteria for PART II:

- Treatment for their cancer considered radical

- either by surgical resection with or without perioperative chemotherapy

- or by thoracic radiotherapy with or without chemotherapy

- having less than 70% of the predicted normal value of the Quadriceps Force (QF) or a
decrease of more than 10% predicted value of the QF between the baseline and
post-radical therapy measurement of QF

- Post treatment assessment maximum 14 days after radical treatment or between 6th and
8th week after radical treatment if the latter consists only of surgical resection

Exclusion Criteria:

Patients presenting with one or more of the following will be excluded:

- Severe anemia (Hb below 8 g/dl)

- Fever (> 38°C)

- Cachexia (loss of more than 35% of premorbid weight)

- Severe cardiac, neurological and orthopedic co-morbidity interfering with exercise
training.

- A pacemaker, hip, knee of shoulder prosthesis or recently introduced spirals, metal
pens, bolts or plates

- Uncontrolled diabetes, epilepsy or migraine

- Uncontrolled vertebral diseases (osteoporotic or metastatic fractures, acute hernia,
discopathy, spondylitis)

- Open wounds

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

The change of 6MWD observed between pre-and post radical treatment

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Jan Van Meerbeeck, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Institutional Review Board

Study ID:

2008/384

NCT ID:

NCT00752700

Start Date:

January 2009

Completion Date:

July 2012

Related Keywords:

  • Respiratory Cancer
  • Patients
  • radically
  • treated

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