Concomitant Use of Radiotherapy and Integrated Exercise - Lung Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Другое Multimodal exercise
  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.

Первичные конечные точки

• Adherence to the exercise program [Срок оценки: From enrollment to the end of treatment at 7-9 weeks]
• Patient Reported Experience Measures [Срок оценки: At the end of intervention at 9 weeks]
• Adverse events [Срок оценки: From start of intervention through 3 months after completion of the intervention (approximately 5 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Hospital Clinic de Barcelona — Barcelona
• Hospital Universitario de Navarra — Pamplona

Идентификаторы

NCT: NCT07489391 · CURIE-LC Pilot

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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