Trial Summary
What is the purpose of this trial?This trial is testing two types of exercise programs for people with advanced lung cancer who are receiving a specific cancer treatment. One program involves short bursts of intense exercise, while the other involves steady, moderate exercise. The goal is to see if these exercises can improve health and reduce side effects from their treatment.
Is High-Intensity Interval Training a promising treatment for lung cancer?Yes, High-Intensity Interval Training (HIIT) is a promising treatment for lung cancer. It is shown to be safe and effective in improving health outcomes for lung cancer patients. HIIT can help patients before and after surgery, and even those with advanced disease, by enhancing their fitness and potentially improving their quality of life.1271213
What safety data exists for exercise treatments like HIIT and MICT?Safety data for exercise treatments such as HIIT and MICT primarily comes from studies on cardiovascular and cancer patients. In cardiovascular patients, HIIT has shown a low rate of major adverse cardiovascular events, with one major event per 17,083 training sessions. Minor cardiovascular and non-cardiovascular events, like musculoskeletal complaints, were also reported. In pediatric cancer patients, a pilot study found HIIT to be feasible without serious adverse events, though it was applicable to a small number of patients. Overall, HIIT and MICT appear to be relatively safe in controlled settings, but individual adaptations may be necessary for patients with multiple impairments.4581011
What data supports the idea that Exercise for Lung Cancer is an effective treatment?The available research shows that high-intensity interval training (HIIT) can improve cardiorespiratory fitness in cancer patients and survivors, which is important for overall health. One study found that HIIT was more effective than moderate-intensity continuous training (MICT) and usual care in improving fitness levels. Although specific data for lung cancer patients is limited, the general benefits of HIIT for cancer patients suggest it could be a helpful treatment option. However, another study indicated that short-term preoperative exercise therapy did not improve long-term outcomes after lung cancer surgery, suggesting that more research is needed to fully understand its effectiveness for lung cancer specifically.236913
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. However, you must have been receiving anti-PD-1 or anti-PD-L1 antibodies for at least one month and plan to continue for at least 12 weeks.
Eligibility Criteria
The INHALE Trial is for adults over 18 with advanced lung cancer who are on single-agent anti-PD-1 or anti-PD-L1 immunotherapy and can exercise safely. They should do less than 60 minutes of moderate-to-vigorous exercise weekly, not be on other systemic treatments like chemo, and must understand English.Inclusion Criteria
I have been diagnosed with metastatic non-small cell lung cancer.
I am not currently on any other cancer treatments.
I am 18 years old or older.
Exclusion Criteria
I do not have another cancer that needs treatment at the same time as this study.
I am not on any other systemic treatments for NSCLC besides anti-PD-1/PD-L1.
Treatment Details
This study tests if a home-based, virtually supervised 12-week exercise program is workable and beneficial for lung cancer patients on immunotherapy. It compares high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), and usual care.
3Treatment groups
Experimental Treatment
Active Control
Group I: Moderate-Intensity Continuous Training (MICT)Experimental Treatment1 Intervention
The MICT group will perform an aerobic exercise at a continuous intensity in each session on a stationary bike. Similar to HIIT, the intensity will be progressed (47.5-60%). The total work of MICT is equalized with HIIT for training volume and frequency to compare the differences exerted from different intensities and energy expenditure.
Group II: High-Intensity Interval Training (HIIT)Experimental Treatment1 Intervention
Patients in the HIIT group will perform alternating vigorous-intensity and recovery aerobic exercise intervals on a provided home stationary bike. The HIIT protocol consists of alternating a high-intensity exercise phase (1 min at 65-90% of workload corresponding to VO2peak) and a recovery phase (1 min at 30%), and the high-intensity and recovery intervals will be repeated 5-10 times in each session.
Group III: Usual Care (UC)Active Control1 Intervention
Participants will be asked to maintain their baseline exercise behavior and will be offered to participate in the HIIT exercise program upon the completion of post-intervention assessments after the initial 12 weeks.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Dana-Farber Cancer InstituteBoston, MA
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Exercise therapy across the lung cancer continuum. [2021]A lung cancer diagnosis and associated therapeutic management are associated with unique and varying degrees of adverse physical/functional impairments that dramatically reduce patients' ability to tolerate exercise. Poor exercise capacity predisposes to increased susceptibility to other common age-related diseases, poor quality of life, and likely premature death. This article reviews the literature investigating the role of exercise as an adjunct therapy across the lung cancer continuum (ie, prevention to palliation). The current evidence suggests that exercise training is a safe and feasible adjunct therapy for patients with operable lung cancer both before and after pulmonary resection. Among patients with inoperable disease, feasibility and safety studies of carefully prescribed exercise training are warranted. Preliminary evidence in this area suggests that exercise therapy may be an important consideration in multidisciplinary management of patients diagnosed with lung cancer.
Short-term preoperative exercise therapy does not improve long-term outcome after lung cancer surgery: a randomized controlled study. [2022]Poor aerobic fitness is a potential modifiable risk factor for long-term survival and quality of life in patients with lung cancer. This randomized trial evaluates the impact of adding rehabilitation (Rehab) with high-intensity interval training (HIIT) before lung cancer surgery to enhance cardiorespiratory fitness and improve long-term postoperative outcome.
Adding high-intensity interval training to conventional training modalities: optimizing health-related outcomes during chemotherapy for breast cancer: the OptiTrain randomized controlled trial. [2019]Exercise training is an effective and safe way to counteract cancer-related fatigue (CRF) and to improve health-related quality of life (HRQoL). High-intensity interval training has proven beneficial for the health of clinical populations. The aim of this randomized controlled trial was to compare the effects of resistance and high-intensity interval training (RT-HIIT), and moderate-intensity aerobic and high-intensity interval training (AT-HIIT) to usual care (UC) in women with breast cancer undergoing chemotherapy. The primary endpoint was CRF and the secondary endpoints were HRQoL and cancer treatment-related symptoms.
High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]Background Cardiac rehabilitation ( CR ) for patients with cardiovascular disease has traditionally involved low- to moderate-intensity continuous aerobic exercise training ( MICT ). There is growing and robust evidence that high-intensity interval training ( HIIT ) shows similar or greater efficacy compared with MICT across a range of cardiovascular and metabolic measures, in both healthy populations and populations with a chronic illness. However, there is understandable concern about the safety aspects of applying HIIT in CR settings. This systematic review analyzed safety data drawn from recent proof-of-concept studies of HIIT during CR among patients with cardiovascular disease. Methods and Results We included trials comparing HIIT with either MICT or usual care in patients with coronary artery disease or heart failure participating in tertiary care services, such as phase 2 (outpatient) CR . Adverse events occurring during or up to 4 hours after an exercise training session were collated. There were 23 studies included, which analyzed 1117 participants ( HIIT =547; MICT =570). One major cardiovascular adverse event occurred in relation to an HIIT session, equating to 1 major cardiovascular event per 17 083 training sessions (11 333 training hours). One minor cardiovascular adverse events and 3 noncardiovascular adverse events (primarily musculoskeletal complaints) were also reported for HIIT . Two noncardiovascular events were reported in relation to MICT . Conclusions HIIT has shown a relatively low rate of major adverse cardiovascular events for patients with coronary artery disease or heart failure when applied within CR settings.
The Effect and Safety of Aerobic Interval Training According to Exercise Intensity in Acute Coronary Syndrome. [2021]To evaluate the effect of increasing the maximal oxygen uptake ((Equation is included in full-text article.)O2max) and the safety of maximal-intensity aerobic interval training (MAIT) compared with high-intensity aerobic interval training (HAIT).
High-intensity interval training improves cardiorespiratory fitness in cancer patients and survivors: A meta-analysis. [2021]Label="OBJECTIVE" NlmCategory="OBJECTIVE">The primary objective of this systematic review and meta-analysis was to compare the effects of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) and usual care (UC) on cardiorespiratory fitness (peak V̇O2 ) in cancer patients and survivors. Secondary objectives were to compare the effects of HIIT versus MICT and UC on other cardiopulmonary exercise testing (CPET) indices. Safety and adherence to HIIT were also evaluated.
Exercise training as part of lung cancer therapy. [2021]Exercise training is playing an increasing role in lung cancer care. Lung cancer is associated with significant burden to the individual and healthcare system. There is now substantial evidence that exercise training is safe, feasible and effective at improving several outcomes in people with lung cancer, especially in those with NSCLC. Exercise is beneficial across the lung cancer disease and treatment pathway, including in patients with early stage disease before and after surgery, and in patients with advanced disease. This review describes the impact of lung cancer and lung cancer treatment on patient health outcomes and summarizes the aims, safety, feasibility and effects of exercise training in the context of both early stage and advanced stage lung cancer. The paper also includes a discussion of current topical discussion areas including the use of exercise in people with bone metastases and the potential effect of exercise on suppression of tumour growth. Finally, seven clinical questions are included, which are a priority to be addressed by future research over the next decade as we strive to progress the field of lung cancer and improve patient outcomes.
Safety and improvement in exercise tolerance with interval training vs moderate-intensity continuous training in heart disease patient of very high cardiovascular risk. [2022]Evaluate safety and effects of training at moderate and high intensity intervals (MIIT, HIIT) compared to continuous moderate intensity training (MICT) in heart disease patient with very high cardiovascular risk (CVR).
Additional cardiovascular fitness when progressing from moderate- to high-intensity exercise training in previously trained breast cancer survivors. [2021]Label="PURPOSE" NlmCategory="OBJECTIVE">Cardiovascular disease, often secondary to chemotherapy, is the leading cause of death in BC survivors. Increased aerobic capacity improves post-rehabilitation survival; however, many cancer rehabilitation programs are limited to lower intensity training. High-intensity interval training (HIIT) is associated with the largest improvements in aerobic capacity; therefore, this study aimed to determine whether HIIT would cause a greater increase in VO2peak than continuous moderate-intensity (MICT) exercise in previously trained BC survivors.
Efficacy of high-intensity interval training compared with moderate-intensity continuous training on maximal aerobic potency in dogs: Trial protocol for a randomised controlled clinical study. [2023]High-intensity interval training (HIIT) is a more efficient method to improve exercise capacity than moderate-intensity continuous training (MICT) because of its greater physiological stimulus.
A Bout of High-Intensity Interval Training (HIIT) in Children and Adolescents during Acute Cancer Treatment-A Pilot Feasibility Study. [2023]Low- and moderate-intensity exercise is safe and feasible during childhood cancer treatment. The feasibility of a bout of high-intensity interval training (HIIT) in this population has not been analyzed to date. Pediatric cancer patients aged between 6 and 18 years were selected based on clinical conditions to perform ten sets of 15 s HIIT (>90% of estimated maximal heart rate (HRmax)) and 1 min active recovery on a bicycle ergometer within the first three chemotherapy courses. We assessed safety and feasibility criteria and the following parameters: perceived exertion rate, heart rate, and lactate and adrenaline concentrations. Out of 212 eligible patients, 11 patients aged 13.9 ± 3.6 years (n = 7 ♂) with lymphoma, leukemia, rhabdomyosarcoma, nephroblastoma, and synovial sarcoma completed the bout of HIIT without serious adverse events. During exercise, patients reached a BORG value maxima of 16 ± 1.2, and their heart rates rose from 78 ± 17 beats per minute (bpm) at rest to 178 ± 12 bpm after exercise (90 ± 6% estimated HRmax). The power-to-weight ratio was 2 ± 0.5 W/kg (watt per kilogram). Blood lactate concentrations increased from 1.09 ± 0.50 mmol/L (millimole per liter) at rest to 5.05 ± 1.88 mmol/L post-exercise. Our preliminary data suggest that HIIT is applicable only in a small number of childhood cancer patients. Individually adapted exercise protocols for patients with multiple impairments are needed.
Exercise across the Lung Cancer Care Continuum: An Overview of Systematic Reviews. [2023]Growing evidence supports exercise for people with lung cancer. This overview aimed to summarise exercise intervention efficacy and safety across the care continuum.
Effects of Preoperative High-Intensity Interval Training Combined With Team Empowerment Education in Lung Cancer Patients With Surgery: A Quasi-experimental Trial. [2023]Cancer itself and surgery put a heavy burden on lung cancer patients, physiologically and psychologically. Enhancing self-efficacy during high-intensity interval training is essential for achieving the full benefit of pulmonary rehabilitation in lung cancer patients.