Clinical trial NCT06051136: Early Versus Delayed Rehabilitation Intervention in Patients With Lung Cancer
Official title: Feasibility of an Early Versus Delayed Rehabilitation Intervention in Patients With Lung Cancer on Cancer-related Fatigue: a Pilot RCT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2023-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, two-arm, open-label pilot RCT.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: The primary outcome of the study is to evaluate the feasibility of the experimental pulmonary rehabilitation (RP) program combining the exercise component with the educational component for patients with lung cancer undergoing chemotherapy and/or radiotherapy and/or immunotherapy, delivering RP at different points in the course of their care pathway. The secondary outcome is to evaluate the impact of the intervention on several health outcomes (CRF, physical performance, and QoL) by assessing any differences between early and delayed RP.

The early RP intervention will be delivered in the first three months of cancer treatment, while the same delayed RP intervention will be delivered three months after the start of treatment. Finally, considering the potential beneficial role that exercise on survival of patients with cancer, this study also aims to evaluate this outcome at 12 months after enrollment.

Eligibility criteria: 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 outcomes:
measure: Feasibility - Adherence rate to the outpatient RP sessions
timeFrame: At 3 and 6 months after baseline
Secondary outcomes:
measure: Recruitment rate
timeFrame: At baseline
measure: Dropout rate
timeFrame: At 3 and 6 months after baseline
measure: Cancer-related fatigue (CRF)
timeFrame: At baseline, at 3, 6, and 12 months after baseline
measure: Quality of life (QoL)
timeFrame: At baseline, at 3, 6, and 12 months after baseline
measure: Physical performance
timeFrame: At baseline, at 3 and 6 months after baseline
measure: Adherence to the exercise home-based sessions
timeFrame: At baseline, at 3 and 6 months after baseline
measure: Physical activity level
timeFrame: At baseline, at 3, 6, and 12 months after baseline
measure: Adverse events
timeFrame: At 3, 6, and 12 months after baseline
measure: Survival
timeFrame: At 12 months after baseline
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
Study officials:
affiliation: Azienda USL Reggio Emilia - IRCCS
name: Stefania Fugazzaro, Dr.
role: PRINCIPAL_INVESTIGATOR
References: