Exercise for Esophageal Cancer

Overseen By Cara Battistella, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Heart insufficiency, Uncontrolled hypertension, Others

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

Compensation: Varies

Number of Visits: 5

20 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Exercise for esophageal cancer?

Research shows that exercise can improve quality of life and muscle strength in esophageal cancer patients, especially after treatment. It also helps enhance cardiorespiratory fitness, which is important for overall health and recovery. ^{1 2 3 4 5}

Is exercise safe for people with esophageal cancer?

Exercise has been studied for its safety in people with esophageal cancer and other conditions. Research shows that exercise can improve fitness and quality of life for esophageal cancer survivors, and it is generally considered safe when done appropriately. ^{3 5 6 7 8}

How does exercise as a treatment for esophageal cancer differ from other treatments?

Exercise as a treatment for esophageal cancer is unique because it focuses on improving cardiorespiratory fitness and quality of life rather than directly targeting the cancer itself. Unlike traditional treatments like surgery or chemotherapy, exercise can enhance overall health and potentially reduce the risk of cancer recurrence and mortality by promoting physical activity. ^{5 6 9 10 11}

What is the purpose of this trial?

The goal of this study is to (1) determine the feasibility of a prehabilitation exercise program (exercise before a medical treatment) in adults with esophageal cancer before surgery (esophagectomy). The pre-surgery exercise program will include resistance and aerobic training during the weeks before surgery. We will also assess pre-surgical care needs in adults with esophageal cancer. Researchers will compare the exercise intervention to usual care- which is standard medical care and post-surgery surveillance/follow-up to understand the impact of exercise before surgery. We will follow-up with participants before surgery, and after surgery at 2 weeks, 6 weeks, and 4-months at appointments that coincide with clinical follow-ups. The main questions of this trials are: * Is exercise before surgery for esophageal cancer feasible and acceptable to patients? * How does exercise before surgery change physical function and psychosocial health? * What are important pre-surgical needs for adults with esophageal cancer?

Research Team

Melanie Potiaumpai, PhD, MPH

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults with esophageal cancer who are scheduled for surgery. It aims to see if exercising before surgery (prehabilitation) is doable and helpful. Participants must be able to perform physical activities and follow the exercise program.

Inclusion Criteria

Ability to provide written informed consent

Ability to understand, speak, and read English.

I have been diagnosed with esophageal cancer.

Exclusion Criteria

I have a medical condition that makes it unsafe for me to exercise.

I have no health issues that stop me from joining exercise programs.

I am undergoing chemotherapy or radiotherapy not related to esophagectomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation Exercise

Participants engage in a prehabilitation exercise program including resistance and aerobic training before surgery

Up to 8 weeks

3-5 sessions per week

Surgery and Immediate Recovery

Participants undergo esophagectomy and immediate post-surgical recovery

Time of Admission

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 months

Follow-ups at 2 weeks, 6 weeks, and 4 months post-surgery

Treatment Details

Interventions

• Exercise

Trial Overview Researchers are testing a pre-surgery exercise regimen that includes resistance and aerobic training against usual care, which involves standard medical care without the added exercise component. They're looking at how this affects patients' physical function and mental health.

Participant Groups

Group I: Home-based prehabilitation exercise (EX) Experimental Treatment 1 Intervention

Interventions will include up to 8 weeks of 3-5 times per week resistance training and 3-5 times per week of aerobic training.

Group II: Usual Care (CONT) Active Control 1 Intervention

The CONT group will not receive any intervention during study participation and undergo usual medical treatment and surveillance during the duration of the study.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Findings from Research

Prehabilitation, especially multimodal approaches, significantly reduces the incidence of postoperative complications and shortens hospital stays for patients undergoing surgery for esophagogastric cancer, based on a meta-analysis of 12 studies involving 910 patients.

While prehabilitation improved outcomes like reducing pulmonary and severe complications, it did not significantly affect 30-day readmission rates or in-hospital mortality, indicating its specific benefits in recovery rather than overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of unimodal or multimodal prehabilitation on patients undergoing surgery for esophagogastric cancer: a systematic review and meta-analysis. Zhao, B., Zhang, T., Chen, Y., et al.[2023]

The RESTORE program, a 12-week multidisciplinary rehabilitation strategy, significantly improved cardiorespiratory fitness in esophagogastric cancer survivors, as evidenced by higher VO2peak measurements at both post-intervention and follow-up assessments.

Despite the improvements in fitness, the program did not lead to changes in body composition or health-related quality of life, indicating that while physical fitness can be enhanced, other aspects of recovery may require different interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The RESTORE Randomized Controlled Trial: Impact of a Multidisciplinary Rehabilitative Program on Cardiorespiratory Fitness in Esophagogastric cancer Survivorship. O'Neill, LM., Guinan, E., Doyle, SL., et al.[2019]

Esophageal cancer survivors showed high adherence to a 12-week supervised exercise program, with a median attendance of 97.9% and compliance to exercises over 90%, indicating that they can effectively participate in post-treatment physical activity.

Key factors that facilitated exercise adherence included the patients' own motivation and supervision by a physiotherapist, while barriers mainly related to logistical issues and physical complaints, particularly affecting adherence to activity advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived facilitators and barriers by esophageal cancer survivors participating in a post-treatment exercise program. van Vulpen, JK., Witlox, L., Methorst-de Haan, AC., et al.[2023]

A systematic review of 9 studies involving over 1.3 million participants found that the most physically active individuals had a 29% lower risk of developing esophageal cancer compared to the least active, suggesting a protective effect of physical activity.

Specifically, physical activity was linked to a 32% reduced risk of esophageal adenocarcinoma (EAC), indicating that increasing physical activity could be an effective lifestyle intervention to lower the incidence of this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity is associated with reduced risk of esophageal cancer, particularly esophageal adenocarcinoma: a systematic review and meta-analysis. Singh, S., Devanna, S., Edakkanambeth Varayil, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Exercise and Nutritional Interventions in Patients with Advanced Gastroesophageal Cancer: A Systematic Review. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of unimodal or multimodal prehabilitation on patients undergoing surgery for esophagogastric cancer: a systematic review and meta-analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Home-based physical activity after treatment for esophageal cancer-A randomized controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The RESTORE Randomized Controlled Trial: Impact of a Multidisciplinary Rehabilitative Program on Cardiorespiratory Fitness in Esophagogastric cancer Survivorship. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Perceived facilitators and barriers by esophageal cancer survivors participating in a post-treatment exercise program. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Physical activity is associated with reduced risk of esophageal cancer, particularly esophageal adenocarcinoma: a systematic review and meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The feasibility of an exercise intervention in males at risk of oesophageal adenocarcinoma: a randomized controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study: design of a randomized controlled trial. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Impacts of physically active and under-active on clinical outcomes of esophageal cancer patients undergoing esophagectomy. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Exercise prehabilitation during neoadjuvant chemotherapy may enhance tumour regression in oesophageal cancer: results from a prospective non-randomised trial. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of the Rehabilitation Program, ReStOre, on Serum Biomarkers in a Randomized Control Trial of Esophagogastric Cancer Survivors. [2022]