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Clinical Trials in Italy / NCT06051136
Active, not recruiting Not applicable

Early Versus Delayed Rehabilitation Intervention in Patients With Lung Cancer

NCT06051136 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda USL Reggio Emilia - IRCCS
Phase
Not applicable
Started
2023-03-10
Last updated
2026-05-07

Condition(s) studied

Lung Cancer

Investigational drug(s) / intervention(s)

Pulmonary rehabilitation

Pulmonary rehabilitation: The RP intervention consists in 8 sessions supervised by the physiotherapist weekly or biweekly and 2 therapeutic education group meetings on the importance of exercise and CRF management, over the 3 months of intervention. The RP comprise exercise program performed autonomously at home. Both the outpatient and the autonomously home-based exercise sessions comprise aerobic, resistance and respiratory exercise. The exercise program is individualized and can be delivered in telerehabilitation.

Study summary

In Italy, the incidence of lung cancer for the year 2020 has been estimated at about 41.000 new diagnoses. Patients with lung cancer experience debilitating symptoms caused by the disease itself and cancer treatments, such as dyspnea and fatigue, which reduce physical function and quality of life (QoL). It is estimated that 90% of patients undergoing chemotherapy and 57% of patients undergoing lung resection suffer of Cancer-Related Fatigue (CRF).

Previous studies have shown that educational interventions and aerobic and resistance exercise are effective in improving CRF and QoL in patients with lung cancer. However, to date the optimal dose, mode and timing to deliver the intervention during the care pathway for lung cancer patients is unknown. Tolerability and frequency of cancer treatment could be a barrier to adherence to the intervention. Therefore, this study aims to evaluate the feasibility of a rehabilitation intervention aimed at improving CRF with respect to timing of delivery: early vs delayed rehabilitation in lung cancer patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Newly diagnosed of stage II and III lung cancer (NSCLC) candidates for anticancer therapies (chemotherapy, radiotherapy, immunotherapy, or combinations thereof), associated or not with surgery. In the last case, patients will be included at least 30 days after surgery. * Prognosis ≥ 12 months * At least 18 years old * Recruited from the pneumology, oncology, radiotherapy, and physical medicine and rehabilitation unit of the Azienda Unità Sanitaria Locale - IRCCS of Reggio Emilia * Willing and able to give written informed consent Exclusion Criteria: * Clinical disorders that contraindicate participation in a moderate exercise program (e.g. preexisting severe physical disabilities, major cognitive or sensory deficits, severe psychiatric disorders, language barrier, etc.). * NSCLC stage IV * Patients who are candidates for surgery alone * Patients who are candidates for neoadjuvant therapy

Primary outcome measure(s)

  • Feasibility - Adherence rate to the outpatient RP sessions — At 3 and 6 months after baseline
    The number of patients adhering to at least 70% of outpatient RP sessions scheduled for the relative allocation group will be recorded.

Trial sites (1)

FacilityCityRegionStatus
Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia Reggio Emilia Reggio Emilia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06051136 on ClinicalTrials.gov ↗ ← All trials in Italy