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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether exercise and nutrition can help people with esophageal cancer prepare for surgery. Participants will either follow a home-based program with workouts and nutrition supplements or adhere to the usual medical care. The study aims to determine if this pre-surgery program is feasible for patients and how it might improve their physical and mental health. It seeks individuals diagnosed with esophageal cancer who plan to undergo surgery in the next few weeks. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance pre-surgery care for future patients.

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 prior data suggests that this exercise and nutrition program is safe for adults with esophageal cancer?

Research has shown that exercise is generally safe for people with esophageal cancer. Physical activity is linked to a lower chance of cancer recurrence and a reduced risk of death. Those who exercise more have a 29% lower risk of developing esophageal cancer compared to those who exercise less. Exercise can also enhance fitness during cancer treatments, making it beneficial for improving health before surgery.

Regarding nutrition, no specific safety concerns have been mentioned. Nutrition supplements are common in many health programs and are usually well-tolerated. Overall, the exercise and nutrition program in this trial is expected to be safe and beneficial for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for esophageal cancer, which typically involve surgery, chemotherapy, and radiation therapy, this trial explores the impact of exercise and nutrition. Researchers are excited about this approach because it focuses on improving patients' physical fitness before surgery through home-based prehabilitation exercise and nutrition. This method includes resistance and aerobic training combined with nutrition supplements, aiming to enhance recovery and potentially improve surgical outcomes by making the body stronger before it faces the stress of surgery. This proactive strategy is unique, as it empowers patients to actively contribute to their treatment process, possibly leading to better overall health and quicker recovery times.

What evidence suggests that this exercise and nutrition program is effective for esophageal cancer?

Research has shown that exercising before esophageal cancer surgery can be beneficial. In this trial, participants in the home-based prehabilitation exercise and nutrition (PRE) arm will engage in prehabilitation, which includes both strength and cardio exercises, along with nutrition supplements, to prepare for surgery. Studies have found that prehabilitation may help patients respond better to chemotherapy. Exercise is also associated with a better quality of life and a lower risk of cancer recurrence or mortality. Early results suggest that even a week of exercise can improve physical fitness, making surgery easier for patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Melanie Potiaumpai, PhD, MPH

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Home-based prehabilitation exercise and nutrition (PRE) 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. * IMPACT Advanced Recovery nutrition supplement drinks: 2 per day for 5 consecutive days leading up to surgery.

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11199248/

Effectiveness of prehabilitation during neoadjuvant therapy for ... Prehabilitation during NAT may be a safe and beneficial intervention strategy for patients with esophageal or gastroesophageal junction cancer.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0748798321006855

Impact of curative treatment on the physical fitness ... This study also concluded that exercise capacity was significantly reduced after neoadjuvant therapy and in the first three months after esophagectomy, and that ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4969406/

Impacts of physically active and under-active on clinical ... Leisure time physical activity was significantly associated with quality of life and risk of recurrence and death of esophageal cancer patients.

4. healio.com healio.com/news/hematology-oncology/20220419/exercise-may-improve-chemotherapy-efficacy-in-esophageal-cancer

Exercise may improve chemotherapy efficacy in ... Patients with esophageal cancer who engaged in prehabilitation exercise demonstrated improved responses to neoadjuvant chemotherapy than those who did not.

5. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-025-01276-2

Feasibility, safety and preliminary effect of exercise ... This study preliminarily demonstrated the effectiveness of one-week exercise prehabilitation on functional capacity and potential benefits for ...

6. bmcgastroenterol.biomedcentral.com bmcgastroenterol.biomedcentral.com/articles/10.1186/1471-230X-14-101

Physical activity is associated with reduced risk of esophageal ... Meta-analysis demonstrated that the risk of esophageal cancer was 29% lower among the most physically active compared to the least physically ...

7. cancer.gov cancer.gov/about-cancer/causes-prevention/risk/obesity/physical-activity-fact-sheet

Physical Activity and Cancer Fact Sheet - NCI A fact sheet that summarizes evidence linking physical activity (including exercise) to reduced cancer risk and sedentary behavior ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0088082

Physical Activity and Risks of Esophageal and Gastric Cancers The summary relative risk of the main results from the 15 studies indicated that the risk of gastric cancer was 13% lower among the most physically active ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2095254625000390?dgcid=rss_sd_all

Feasibility and clinical potential of exercise interventions ... Exercise during neoadjuvant chemoradiotherapy (NCRT) has potential to mitigate treatment-related declines in physical fitness, and to improve clinical outcomes.