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AzTrials

Lung CancerOVER-CRFNCT06051136

Early Versus Delayed Rehabilitation Intervention in Patients With Lung Cancer

A study testing Pulmonary rehabilitation in people with Lung Cancer, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Pulmonary rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteItaly
Study dates
10 Mar 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia

    Reggio Emilia, Reggio Emilia, 42123

Other trials in Italy

About this study

Official title: Feasibility of an Early Versus Delayed Rehabilitation Intervention in Patients With Lung Cancer on Cancer-related Fatigue: a Pilot RCT

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.

Read the 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.

Conditions
Lung Cancer
Being tested
Pulmonary rehabilitation
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary rehabilitationBehavioural

    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 groups in NCT06051136
Study groupRoleWhat they receive
Early pulmonary rehabilitation (RP)ExperimentalRP immediately after enrollment.
Receives: Behavioral: Pulmonary rehabilitation
Delayed pulmonary rehabilitation (RP)ExperimentalRP after 3 months after enrollment.
Receives: Behavioral: Pulmonary rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - Adherence rate to the outpatient RP sessions

    The number of patients adhering to at least 70% of outpatient RP sessions scheduled for the relative allocation group will be recorded.

    Measured: At 3 and 6 months after baseline

Secondary outcomes (9)

  1. Recruitment rate

    The recruitment rate will be estimated with the sample rate calculated as the ratio of the number of patients who partecipate to the study to the number of patients to whom the study is proposed.

    Measured: At baseline

  2. Dropout rate

    Number of treatment failures, their causes, and number of sessions conducted

    Measured: At 3 and 6 months after baseline

  3. Cancer-related fatigue (CRF)

    CRF will be measured with The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F). The score ranges from 0 to 52. Higher score represents less fatigue experienced by patient. The minimum clinically significant difference for the FACIT-F scale has been estimated at 3 points.

    Measured: At baseline, at 3, 6, and 12 months after baseline

  4. Quality of life (QoL)

    QoL will be measured by EORTC- QLQ-C30 questionnaire. The QLQ-C30 consists of 30 items, which assess various dimensions of HRQL: five scales of functioning (physical, role, emotional, cognitive and social), three scales assessing symptoms (fatigue, pain and nausea) and a global measure of health status. The remaining six single-question scales assess symptoms: dyspnea, loss of appetite, sleep disorders, constipation and diarrhea, and the perceived economic impact of treating the disease. High scores indicate better HRQL for global health status and functioning scales, but worse symptoms. The minimum clinically significant difference for the EORTC QLQ-C30 scale was estimated to be between 5 and 10 points.

    Measured: At baseline, at 3, 6, and 12 months after baseline

  5. Physical performance

    Physical performance will be neasured by six minute walk test (6MWT). The 6MWT consists of measuring the distance covered in six minutes. Saturation, heart rate, respiratory and muscle fatigue and the number of stops are also releved at both the start and finish. The minimum clinically significant difference for the 6MWT in lung cancer patients was estimated to be 42 m.

    Measured: At baseline, at 3 and 6 months after baseline

  6. Adherence to the exercise home-based sessions

    Number of exercise home-based sessions performed by each patient

    Measured: At baseline, at 3 and 6 months after baseline

  7. Physical activity level

    Physical activity level will be measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF). IPAQ-SF is a questionnaire used to estimate the amount of physical activity during the previous 7 days. Weekly frequency and average duration of vigorous and moderate physical activity and walking (regardless of whether during work or leisure time) and the number of daily hours spent sitting are asked. In addition, to assess the level of physical activity performed, IPAQ uses METs (Metabolic Equivalent Tasks).

    Measured: At baseline, at 3, 6, and 12 months after baseline

  8. Adverse events

    Recording of adverse events related to the exercise intervention during the 6-month intervention period (falls, fractures, muscle pain, exertional dyspnea, acute inflammation of joints stressed in the rehabilitation program, hematomas, etc.).

    Measured: At 3, 6, and 12 months after baseline

  9. Survival

    Measured: At 12 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2023
  2. Study start10 Mar 2023
  3. Primary completion23 Dec 2024
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-center, two-arm, open-label pilot RCT.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06051136
Sponsor's protocol ID
OVER-CRF
Acronym
OVER-CRF
Status last verified
May 2026
First submitted
17 Sep 2023
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fugazzaro S, Mainini C, Pecorari A, Denti M, Galavotti MB, Messori M, Costi S, Ciammella P, Falco F, Zanelli F, Cavuto S, Bressi B. Feasibility of an early versus delayed rehabilitation intervention in patients with lung cancer on cancer-related fatigue: a pilot RCT. Future Oncol. 2026 Jan;22(2):147-156. doi: 10.1080/14796694.2025.2607632. Epub 2026 Jan 6.

    PubMed 41496492

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary rehabilitation in people with Lung Cancer, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Adherence rate to the outpatient RP sessions (time frame: At 3 and 6 months after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06051136, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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