Concomitant Use of Radiotherapy and Integrated Exercise - Lung Cancer

NCT07489391 | Recruiting

• 1 other identifier: CURIE-LC Pilot
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer; Radiation Therapy Patient; Stage II/III

Keywords

Lung Cancer; Exercise; Radiochemotherapy

Outcome Measures

Primary Outcomes (3)

• Adherence to the exercise program

  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: 1. the overall mean adherence is ≥70% of the prescribed dose; and 2. ≥70% of participants achieve ≥70% adherence.

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

• Patient Reported Experience Measures

  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.

  At the end of intervention at 9 weeks

• Adverse events

  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.

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

Study Arms (1)

Multimodal exercise program during chemoradiotherapy

EXPERIMENTAL

Patients will start 2 weeks prior to radiotherapy treatment. The intervention will consist of 3 days of aerobic exercise, 2 days of resistance training and 5 days of unsupervised inspiratory muscle training during 9 weeks.

Other: Multimodal exercise

Interventions

Multimodal exercise OTHER

The intervention consists of 7-9 weeks of multimodal exercise training prior to radiotherapy session. 1. Aerobic exercise: 40' of moderate intensity on stationary bike or treadmill; 3 days/week. 2. Resistance training: 16 sets of 8 reps. at 80% of 1RM; 1' rest between sets; 2 days/week. 3. Inspiratory Muscle Training: 2x30 breathing cycles at 30% of PIMax + 5% weekly improvement; 4 days unsupervised + 1 supervised session.

Also known as: Aerobic exercise, Resistance training, Breathing exercise

Multimodal exercise program during chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Deusto: lead
• Hospital Clinic of Barcelona: collaborator
• Hospital of Navarra: collaborator

Study Sites (2)

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Motor Activity

Interventions

Exercise; Resistance Training; Breathing Exercises

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques

Central Study Contacts

Jurgi Zulaika

CONTACT

+34 943 32 66 00; jurgi.zulaika@deusto.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)