Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05306652

Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment

Led by AUSL Romagna Rimini · Updated on 2023-05-31

40

Participants Needed

1

Research Sites

217 weeks

Total Duration

On this page

Sponsors

A

AUSL Romagna Rimini

Lead Sponsor

F

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is an interventional, non-pharmacologic, randomized controlled study evaluating the impact on quality of life of a personalized exercise program in oncogene addicted lung cancer patients undergoing active treatment. Patients will be randomized 1:1 in two arms: arm A (interventional) and arm B (control). The program of physical activity will be established after a test done at the local clinical center and based on easy exercises already studied in other diseases (e.g. coronary syndrome or organ transplant). A smartphone application will allow patients to register their daily physical activity and to easily recover data on strength and endurance. Patients in Arm A will have a home-based physical activity prescription and will be supervised at weeks: 4, 6, 8, 10, 12 by the oncologist and an exercise expert of the local sport center through three exercises (body composition test, endurance test and strength test) and questionnaires. Home-based activity will be monitored daily though a specific application (provided by Technogym). Patients in Arm B will receive an exercise counselling without a subsequent supervision. The three tests and questionnaires will be repeated once a month for three months at the local sport center and oncology center. Counselling will include general information on exercise. Patients will undergo blood sampling at baseline, week 4 and week 12 in order to evaluate changes in their immunological state (lymphocyte populations and cytokines).

CONDITIONS

Official Title

Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Willingness to provide written informed consent
  • Life expectancy greater than 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Body mass index greater than 18
  • Diagnosis of oncogene-addicted (EGFR, ALK, ROS1, RET, BRAF) stage IV or IIIb non-small cell lung cancer not suitable for local treatment
  • Receiving first- or second-line systemic treatment (palliative radiotherapy and prior chemotherapy allowed)
  • Patients currently undergoing treatment in clinical trials are excluded
Not Eligible

You will not qualify if you...

  • Unable to walk
  • Immobility for more than 3 days before study enrollment
  • Untreated symptomatic brain metastases (non-irradiated or non-resected)
  • Severe cardiac impairment (e.g., New York Heart Association (NYHA) class greater than III, recent myocardial infarction within 3 months, severe arrhythmias, high-grade aortic stenosis)
  • Severe respiratory failure
  • Uncontrolled pain
  • Bone metastasis causing increased risk of fractures

AI-Screening

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Trial Site Locations

Total: 1 location

1

S.Maria delle Croci Hospital, Oncology Unit

Ravenna, Italy

Actively Recruiting

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Research Team

C

Chiara Bennati, MD

CONTACT

M

Michela Spreafico

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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