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NCT Number: NCT07489391

Concomitant Use of Radiotherapy and Integrated Exercise - Lung Cancer

Study objective and procedures

The objective of CURIE-LC is to evaluate the feasibility (i.e., whether it is possible and safe) of carrying out a comprehensive exercise program during combined radiotherapy and chemotherapy in patients with lung cancer. The study will assess whether patients can adhere to the exercise program while receiving oncologic treatment and will explore its effects on physical fitness and quality of life.

What does participation involve?

If participants choose to take part, they will join a supervised exercise program conducted throughout the chemoradiotherapy treatment. The program includes three main components, tailored to the individuals' abilities:

Inspiratory breathing exercise: training with a specialized device to strengthen the breathing muscles and improve lung capacity.

Aerobic exercise: moderate-intensity aerobic activity (e.g., treadmill walking or stationary cycling) several days per week to improve endurance and cardiovascular health.

Strength training: muscle-strengthening exercises (e.g., light weights or resistance bands) twice per week to maintain or increase arm and leg strength.

A physiotherapist or other trained professional will guide the participant at all times to ensure exercises are performed safely and appropriately. Sessions will last approximately 20 to 60 minutes and will be coordinated with the radiotherapy/chemotherapy schedule so as not to interfere with the treatment.

In addition to the exercise sessions, participants will undergo physical assessments and complete questionnaires at several time points. Before starting and at the end of the program, the investigagtors will measure functional capacity using the 6-minute walk test (6MWT) and assess respiratory muscle strength using maximal inspiratory and expiratory pressures (PImax and PEmax). Handgrip strength will also be measured. Participants will complete questionnaires about health status, fatigue, mood, and quality of life. These evaluations will help determine the impact of exercise during treatment.

The exercise program will last for the duration of the treatment, approximately 7 to 9 weeks, with a short-term follow-up after treatment ends. Overall, participation involves attending the scheduled weekly exercise sessions during treatment, plus several evaluation visits (before, during, at the end of the program, and a few months later). Exact timing and frequency will be explained and planned according to the individual situation, aiming to minimize disruption to daily routine.

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Key information

Conditions

Non Small Cell Lung Cancer Behavior Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Radiation Therapy Patient Respiratory Tract Diseases Respiratory Tract Neoplasms Stage II/III Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona, Barcelona, Catalonia, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological diagnosis of non-small cell lung cancer (NSCLC) at stage II-III (locally advanced), unresectable/inoperable.
  • Candidate for radical radiotherapy with concomitant chemotherapy, with or without maintenance Durvalumab.
  • ECOG performance status ≤2 (or Karnofsky index ≥60).
  • Ability to communicate adequately with the research team and to complete questionnaires and functional tests.
  • Signed written informed consent after receiving detailed information about the study.

Exclusion criteria

  • Decompensated cardiorespiratory comorbidities that contraindicate moderate-intensity physical exercise:
  • New York Heart Association (NYHA) class III-IV congestive heart failure or unstable angina.
  • Recent myocardial infarction (<6 months) or uncontrolled arrhythmias.
  • Very severe chronic obstructive pulmonary disease (COPD) GOLD IV with recent exacerbations, permanent home oxygen therapy, or severe pulmonary hypertension.
  • Severe physical or neurological limitations that prevent exercise.
  • Absolute medical contraindications to inspiratory muscle training: unresolved pneumothorax, recent thoracic surgery (<4 weeks), or active hemoptysis.
  • Refusal or inability to understand/follow the program instructions (e.g., severe cognitive impairment, insurmountable language barrier).

Treatment and study plan

Multimodal Exercise

Other

The intervention consists of 7-9 weeks of multimodal exercise training prior to radiotherapy session.

  • Aerobic exercise: 40' of moderate intensity on stationary bike or treadmill; 3 days/week.
  • Resistance training: 16 sets of 8 reps. at 80% of 1RM; 1' rest between sets; 2 days/week.
  • Inspiratory Muscle Training: 2x30 breathing cycles at 30% of PIMax + 5% weekly improvement; 4 days unsupervised + 1 supervised session.

Other names: Aerobic exercise, Resistance training, Breathing exercise

Primary outcomes

  1. Adherence to the exercise program

    Time frame: From enrollment to the end of treatment at 7-9 weeks

    Adherence will be primarily measured as compliance with the prescribed exercise dose, not only attendance. Each participant will complete a structured diary (daily log) that will record:

    • IMT: minutes and sets completed.
    • Aerobic exercise: minutes, modality, and perceived intensity using the modified Borg scale.
    • Strength exercise: exercises/sets/repetitions completed and load (or perceived effort).

    During supervised sessions, the physiotherapist will confirm compliance; during unsupervised sessions, the diary will be reviewed weekly.

    Adherence will be calculated using the average of components weighted by the prescribed dose, and the program will be considered feasible if:

    • the overall mean adherence is ≥70% of the prescribed dose; and
    • ≥70% of participants achieve ≥70% adherence.

  2. Patient Reported Experience Measures

    Time frame: At the end of intervention at 9 weeks

    Evaluates the patient's satisfaction with and acceptance of the program.

    Measurement instrument: An ad hoc-designed satisfaction survey, with standardized items on a Likert scale (e.g., overall satisfaction, perceived usefulness, session comfort, likelihood of recommending the experience, etc.).

    Procedure: The satisfaction survey will be administered at the end of the intervention. Patients' responses regarding different organizational and perceived aspects of the program will be collected; these responses will be transformed into quantitative scores (0-10 or 1-5 depending on the Likert scale used) and/or into the proportion of positive responses. This PREM will provide information on the acceptability of the intervention.

  3. Adverse events

    Time frame: From start of intervention through 3 months after completion of the intervention (approximately 5 months)

    Refers to the incidence of clinical adverse effects related to oncological treatment or to the performance of exercise.

    Measurement instrument: Standardized toxicity recording according to CTCAE v5.0 criteria (Common Terminology Criteria for Adverse Events, version 5.0).

    Procedure: Throughout the study, adverse events will be systematically monitored and documented, distinguishing those associated with radio/chemotherapy treatment from those potentially attributable to exercise. In particular, the following will be monitored: acute pneumonitis ≥ grade 2, radiation-induced esophagitis, weight loss ≥5% from baseline, unplanned hospitalizations, and hematological toxicities (e.g., neutropenia, anemia, or thrombocytopenia ≥ grade 2).

    Each event will be evaluated by the radiation oncologist using the CTCAE v5.0 scale to assign a severity grade. The exercise program will be considered safe if no serious exercise-related adverse events are observed.

Study contacts

Contact information is provided by the study sponsor or research team.

Jurgi Zulaika

CONTACT

[email protected]

+34 943 32 66 00 ext. 5190

Sponsors and collaborators

Lead sponsor

University of Deusto

Other

Collaborators

  • Hospital Clinic of Barcelona
  • Hospital of Navarra

Registry information

Official study title

Effect of an Integrated Exercise Program Concomitant With Radiotherapy on Functional Capacity in Patients With Lung Cancer

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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