Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• Willingness to provide written informed consent.

• Life expectancy \>12 weeks.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

• Body massa index \> 18.

• Oncogene-addicted (EGFR, ALK, ROS1, RET, BRAF) stage IV or III b not suitable for local treatment receiving first- or second-line systemic treatment (palliative radiotherapy and prior chemotherapy allowed). Patients undergoing treatment in clinical trials are excluded.

Locations
Other Locations
Italy
S.Maria delle Croci Hospital, Oncology Unit
RECRUITING
Ravenna
Contact Information
Primary
Chiara Bennati, MD
chiara.bennati@auslromagna.it
+39 0544 285778
Backup
Michela Spreafico
michela.spreafico@irst.emr.it
Time Frame
Start Date: 2022-04-04
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 40
Treatments
Experimental: A - Home based supervised physical exercise
patients will have a home-based physical activity prescription
Active_comparator: B- Unsupervised physical exercise
patients will receive a physical activity counselling, without a real prescription and supervision
Sponsors
Leads: AUSL Romagna Rimini
Collaborators: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

This content was sourced from clinicaltrials.gov