Supportive Care for Lung Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Prisoners

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a special supportive care program can improve the physical and emotional well-being of people with advanced lung cancer during treatment. Participants will engage in activities such as physical therapy and relaxation exercises to determine their impact on overall well-being and quality of life. This trial suits individuals aged 60 and older with advanced lung cancer who are receiving treatment at the Ohio State University Comprehensive Cancer Center. As an unphased trial, it offers a unique opportunity to enhance quality of life through supportive care.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, as there are no specific exclusions related to medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on supportive care interventions like physical therapy and relaxation, so it's likely you can continue your current treatments, but you should confirm with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that exercise can benefit people with lung cancer by improving fitness, strength, and quality of life. Studies indicate that it can reduce cancer-related fatigue and assist those with advanced lung cancer. This suggests that exercise is generally safe for these patients.

Physical therapy, often incorporating exercise, is also safe. It can enhance physical abilities and improve quality of life, helping with fatigue and fitness.

Relaxation therapy, such as progressive muscle relaxation, is another safe option. It can reduce stress and anxiety and may alleviate symptoms like shortness of breath and pain.

Overall, these treatments are well-tolerated and have demonstrated benefits for people with lung cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for lung cancer because they combine physical therapy with progressive muscle relaxation exercises. Unlike standard care, which usually focuses on medication and surgery, this approach incorporates exercise and relaxation to potentially enhance patients' overall well-being and quality of life. By integrating these supportive care techniques, the trial aims to improve physical function and reduce stress, offering a holistic complement to conventional cancer treatments.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that physical activity and exercise can significantly benefit lung cancer patients by reducing fatigue, improving cardiovascular and pulmonary fitness, and enhancing quality of life. In this trial, participants in Arm I will receive a combination of physical therapy, an exercise intervention, and relaxation exercises. Studies have found that exercise can also enhance the effectiveness of cancer treatments. Physical therapy, such as pulmonary rehabilitation, improves lung function and facilitates exercise, accelerating recovery. Relaxation exercises can alleviate symptoms like shortness of breath and pain while boosting mood and overall quality of life. Together, these activities can enhance both physical and emotional well-being for those undergoing lung cancer treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Carolyn J. Presley, MD, MHS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older with advanced lung cancer (stage IIIA, IIIB, or IV non-small cell lung cancer or extensive stage small cell lung cancer). They must be able to understand and sign a consent form, have a certain level of physical function, and plan to receive treatment at the Ohio State University Comprehensive Cancer Center. Prisoners are not eligible.

Inclusion Criteria

My lung cancer is at an advanced stage and cannot be surgically removed.

I can join the study at any stage of my treatment at OSU.

You have a score of 2 or higher on the three functional questions of the EQ5D5L patient survey.

Exclusion Criteria

My health status, lab values, past cancers, other illnesses, or brain metastases do not disqualify me.

Prisoners are excluded from participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the ROAR-LCT intervention or standard of care for 12 weeks. The ROAR-LCT intervention includes weekly physical therapy visits and progressive muscle relaxation exercises.

12 weeks

Weekly visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of functional status and psychological symptoms.

12 months

Long-term follow-up

Participants are followed up for up to 24 months after the date of study enrollment to assess long-term outcomes.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention
• Physical Therapy
• Relaxation Therapy

Trial Overview

The ROAR-LCT trial is testing a supportive care intervention aimed at improving physical and emotional wellbeing in patients undergoing treatment for advanced lung cancer. It includes questionnaires, quality-of-life assessments, relaxation therapy like muscle relaxation exercises, best practice guidelines adherence, and an exercise program managed by physical therapists.

How Is the Trial Designed?

Group I: Arm I (ROAR-LCT intervention) Experimental Treatment 5 Interventions

Patients receive ROAR-LCT intervention weekly for 12 weeks consisting of physical therapy visits and an exercise intervention. Patients also undergo progressive muscles relaxation exercises over 20 minutes for 12 weeks.

Group II: Arm II (standard of care) Active Control 3 Interventions

Patients receive standard of care for 12 weeks.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Pulmonary rehabilitation significantly improves lung function, exercise capacity, and quality of life in lung cancer patients undergoing chest surgery, as shown by a comprehensive review of studies.

This intervention is effective in enhancing respiratory and peripheral muscle function, lung mechanics, and overall physical activity, making it a crucial component of care for patients with lung cancer and related respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and quality of life in lung cancer, pre-, post- and perioperative rehabilitation - A review. Abidi, Y., Fekete, M., Farkas, Á., et al.[2023]

Pulmonary rehabilitation significantly enhances the quality of life for lung cancer patients by improving their functional capacity and endurance through tailored exercise programs and various supportive techniques.

This intervention is increasingly integrated into palliative care, helping patients manage breathlessness and maintain activity levels during chemotherapy and radiation therapy, ultimately boosting their self-efficacy and participation in family life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Rehabilitation and Palliative Care for the Lung Cancer Patient. Tiep, B., Sun, V., Koczywas, M., et al.[2022]

Pulmonary rehabilitation (PR) is a comprehensive and individualized care approach for patients with chronic pulmonary disorders, particularly chronic obstructive pulmonary disease (COPD), focusing on assessment, education, exercise, and psychosocial support.

Exercise training is a key component of PR, significantly improving patients' exercise tolerance, reducing dyspnea, and enhancing health-related quality of life, with follow-up care being essential for maintaining long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of pulmonary rehabilitation and clinical practice]. Machida, K.[2011]

Pulmonary rehabilitation, which includes physical training, education, and lifestyle changes, is an effective intervention for chronic respiratory disorders beyond just COPD, such as interstitial lung diseases and pulmonary hypertension.

Recent studies suggest that clinicians should consider pulmonary rehabilitation for a wide range of chronic lung conditions, including lung cancer and obesity, highlighting its versatility and potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation in respiratory disorders other than COPD : an individualized approach]. Janssens, JP., Chappuis-Gisin, É., Maragkoudakis, C., et al.[2019]

Pulmonary rehabilitation is a comprehensive, non-medication intervention that has shown potential benefits for patients with chronic respiratory diseases, including those with lung cancer.

Preliminary studies indicate that pulmonary rehabilitation can improve exercise tolerance, enhance quality of life, and reduce surgical complications in lung cancer patients, suggesting it may be a valuable addition to their treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation in the management of patients with lung cancer]. Qiao, Y., Qiu, X., Zhou, Q.[2021]

Pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD) significantly improves symptoms like shortness of breath (dyspnea), exercise capacity, and overall quality of life, as well as reducing healthcare resource use.

The effectiveness of exercise training during rehabilitation can be enhanced by using bronchodilators, supplemental oxygen, and noninvasive ventilatory support, allowing patients to train at higher intensities for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The roles of bronchodilators, supplemental oxygen, and ventilatory assistance in the pulmonary rehabilitation of patients with chronic obstructive pulmonary disease. ZuWallack, RL.[2008]

A study of 47 patients with non-small cell lung cancer (NSCLC) showed that participating in a multidisciplinary pulmonary rehabilitation program significantly improved their lung function and exercise capacity after cancer treatment, with notable increases in forced expiratory volume and 6-minute walk test distance.

The improvements in pulmonary function and exercise capacity were consistent regardless of the presence of chronic obstructive pulmonary disease (COPD) or whether patients had undergone thoracic surgery, indicating that pulmonary rehabilitation can be beneficial for a broad range of NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation in non-small cell lung cancer patients after completion of treatment. Glattki, GP., Manika, K., Sichletidis, L., et al.[2012]

Exercise interventions for lung cancer patients are both safe and effective, leading to improvements in physical fitness, muscle strength, and quality of life, as well as reductions in cancer-related fatigue and dyspnoea.

Prehabilitation, or exercising before treatment, has been shown to enhance recovery outcomes after surgery, highlighting the importance of individualized exercise plans throughout the cancer care journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity for people with lung cancer. Edbrooke, L., Granger, CL., Denehy, L.[2020]

Exercise interventions for lung cancer patients significantly reduce post-operative complications and improve exercise capacity, based on a systematic review of 30 studies involving a total of 6440 participants.

While exercise showed benefits in pre- and post-operative settings, health-related quality of life improvements were mostly non-significant, indicating a need for further high-quality research, especially in non-surgical populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise across the Lung Cancer Care Continuum: An Overview of Systematic Reviews. Edbrooke, L., Bowman, A., Granger, CL., et al.[2023]

Exercise-based, multimodal rehabilitation programs for cancer patients have shown significant improvements in physical health, particularly in cardiorespiratory fitness and walking distance, with clinically meaningful effect sizes.

To enhance the overall benefits of these rehabilitation programs, there is a need for greater focus on nutrition, psychosocial support, and management of cardiovascular risk factors tailored specifically for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Structure and Health Impacts of Exercise-Based Cardiac and Pulmonary Rehabilitation and Prehabilitation for Individuals With Cancer: A Systematic Review and Meta-Analysis. Rickard, JN., Eswaran, A., Small, SD., et al.[2023]

Preoperative exercise interventions, particularly those combining aerobic, strength, and inspiratory muscle training, significantly improve functional outcomes in patients with non-small-cell lung cancer (NSCLC), including walking endurance and peak exercise capacity, based on a meta-analysis of 10 randomized controlled trials involving 676 participants.

These exercise protocols also reduce the risk of hospitalization and postoperative pulmonary complications, suggesting that prehabilitation can enhance recovery and overall medical care for NSCLC patients undergoing surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-Analysis of Randomized, Controlled Trials on Preoperative Physical Exercise Interventions in Patients with Non-Small-Cell Lung Cancer. Rosero, ID., Ramírez-Vélez, R., Lucia, A., et al.[2020]

Prehabilitation programs, particularly high-intensity interval training (HIT) lasting 2 to 6 weeks, are safe and can improve exercise capacity and pulmonary function in patients undergoing thoracic surgery for non-small cell lung cancer (NSCLC).

While prehabilitation shows promise in enhancing physical capacity, its effectiveness in reducing postoperative complications and mortality remains unclear, necessitating further randomized clinical trials to better understand its benefits, especially in patients with impaired lung function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in thoracic surgery. Sanchez-Lorente, D., Navarro-Ripoll, R., Guzman, R., et al.[2020]

In a study of 20 patients with advanced lung cancer undergoing chemotherapy, those who participated in an 8-week pulmonary rehabilitation program showed significant improvements in lung function, specifically a notable increase in forced expired volume in 1 second (p = 0.016).

Patients in the rehabilitation group also experienced reduced dyspnea (p = 0.05) and a tendency for improved quality of life, suggesting that pulmonary rehabilitation can be a beneficial intervention for enhancing mobility and overall well-being during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Rehabilitation in Advanced Lung Cancer Patients During Chemotherapy. Jastrzębski, D., Maksymiak, M., Kostorz, S., et al.[2016]

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