Personalized exercise program for lung cancer patients undergoing treatment
Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment: a Randomized Controlled Trial
This study is testing whether a personalized exercise program can help improve the quality of life for lung cancer patients who are currently undergoing treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AUSL Romagna Rimini Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ravenna) |
| Trial ID | NCT05306652 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates the impact of a personalized exercise program on the quality of life of patients with oncogene addicted non-small cell lung cancer (NSCLC) who are currently receiving active treatment. Participants will undergo baseline tests to assess body composition, endurance, and strength before being randomized into two groups: one receiving a home-based exercise prescription and supervision, and the other serving as a control. The exercise program will be tailored based on individual test results and monitored through a smartphone application. The study aims to determine if structured physical activity can enhance patient outcomes during treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with oncogene addicted stage IIIb or IV non-small cell lung cancer who are receiving systemic treatment.
Not a fit: Patients who are unable to walk or have severe cardiac or respiratory issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could improve the quality of life and physical well-being of lung cancer patients during their treatment.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in cancer patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older 2. Willingness to provide written informed consent. 3. Life expectancy \>12 weeks. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 5. Body massa index \> 18. 6. 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. Exclusion Criteria: 1. Inability to walk. 2. Immobility for more than 3 days before study enrollment. 3. Previously untreated (non-irradiated or non-resected) symptomatic brain metastases. 4. Severe cardiac impairment (e.g. cardiac insufficiency New York Heart Association (NYHA) \> III, myocardial infarction within the last three months, severe cardiac arrhythmias, high grade aortic stenosis). 5. Severe respiratory failure. 6. Uncontrolled pain. 7. Bone metastasis inducing increased risk of pathological fractures.
Where this trial is running
Ravenna
- S.Maria delle Croci Hospital, Oncology Unit — Ravenna, Italy (Recruiting)
Study contacts
- Principal investigator: Chiara Bennati — AUSL Romagna
- Study coordinator: Chiara Bennati, MD
- Email: chiara.bennati@auslromagna.it
- Phone: +39 0544 285778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.