Exercise Prehabilitation for Esophageal Cancer

Overseen By Nathan Parker, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Unstable cardiac, Pulmonary, Recent fracture, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an exercise program can help people with esophageal cancer prepare for surgery. Participants will engage in resistance training twice a week using provided equipment and will track their steps with a Fitbit. This trial suits individuals with esophageal cancer who plan to undergo surgery and are not currently engaged in regular resistance training. As an unphased trial, it offers a unique opportunity to enhance surgical readiness through exercise.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that exercise prehabilitation is safe for patients preparing for esophageal cancer resection?

Research has shown that exercise is generally safe and manageable for patients, including those preparing for surgery. Studies have found that physical activity can improve quality of life and reduce the risk of esophageal cancer recurrence or progression. No evidence indicates serious harm from exercise in patients with esophageal cancer. In fact, a review of several studies found that more active individuals have a 29% lower risk of developing esophageal cancer compared to less active individuals.

Regarding safety, exercise prehabilitation, a planned exercise program, has been studied and found to be feasible and safe for cancer patients. Patients can typically handle it well without major issues. Overall, exercise can be a beneficial and safe component of preparing for cancer surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise prehabilitation for esophageal cancer because it offers a proactive approach to patient care that differs from the typical reliance on surgery, chemotherapy, and radiation. This method focuses on boosting physical fitness and resilience before undergoing cancer treatment, potentially leading to better outcomes and faster recovery. By incorporating resistance training and activity monitoring with devices like Fitbits, this approach aims to improve patients' overall health status, which is not addressed by standard treatment options.

What evidence suggests that exercise prehabilitation is effective for esophageal cancer?

Research shows that exercise can benefit people with esophageal cancer. One study found that more active individuals have a 29% lower risk of developing esophageal cancer compared to less active individuals. After treatment, exercise strengthens muscles, particularly in the legs. Patients can complete supervised exercise programs post-treatment, gaining numerous benefits. Exercise also links to improved quality of life and may reduce the risk of cancer recurrence or mortality. In this trial, participants will engage in an exercise prehabilitation program before surgery, potentially aiding their preparation for esophageal cancer surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Nathan Parker, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals preparing for esophageal cancer surgery. It's designed to see if exercising before the operation, known as 'prehabilitation,' is doable and acceptable.

Inclusion Criteria

My esophageal cancer is confirmed by biopsy and has not spread far.

My treatment plan includes chemotherapy, radiation before surgery.

I am able to care for myself and perform daily activities.

Exclusion Criteria

Regular engagement in resistance training (2x/week targeting all major muscle groups)

I have a recent fracture or injury that stops me from safely doing resistance training.

I have a muscle or joint disease affecting my physical ability.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Prehabilitation

Participants engage in an exercise program for 5 to 17 weeks, including resistance training sessions twice per week and step count monitoring with a Fitbit device.

5 to 17 weeks

Follow-up

Participants are monitored for retention and improvements in exploratory outcome measures.

Up to 17 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study tests an exercise program tailored for patients awaiting esophageal cancer resection. The focus is on whether patients can follow this regimen and how they feel about it.

How Is the Trial Designed?

Group I: Exercise prehabilitation Experimental Treatment 1 Intervention

In this trial participants will participate in an exercise program for 5 to 17 weeks, varying with treatment plans. Participants will receive resistance training equipment and participate in resistance training sessions twice per week (approximately 30-45 minutes per session). A Fitbit device will be provided to monitor step counts.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Published Research Related to This Trial

In a study of 92 patients with oesophageal cancer, those who participated in a multimodal prehabilitation program had a significantly higher rate of completing their neoadjuvant chemotherapy compared to those who did not receive prehabilitation (p = 0.029).

The results suggest that prehabilitation may enhance patients' tolerance to chemotherapy, indicating a potential benefit for optimizing cancer treatment, although further research is needed to explore its long-term effects on cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Prehabilitation Improves Tolerance to Chemotherapy in Patients with Oesophageal Cancer. Christodoulidis, G., Halliday, LJ., Samara, A., et al.[2023]

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]

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]

Physical prehabilitation programs, which include various forms of exercise training, can lead to improvements in respiratory muscle function and may reduce postoperative complications and hospital stay for patients undergoing surgery for esophagogastric cancers, based on a review of seven studies with 645 participants.

Despite some positive outcomes, the review highlights the need for higher quality randomized controlled trials due to the limited number of studies and variability in program designs, which affects the reliability of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the impact and the optimal design of a physical prehabilitation program in patients with esophagogastric cancer awaiting surgery? A systematic review. Piraux, E., Reychler, G., de Noordhout, LM., et al.[2021]

In a study of 67 oesophageal cancer patients, a personalized pre-operative exercise program helped maintain and even improve cardiorespiratory fitness during neoadjuvant chemotherapy, with significant increases noted just before surgery.

Higher adherence to the exercise program and greater volumes of physical activity were linked to a lower risk of post-operative pneumonia, emphasizing the importance of consistent exercise during prehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Pre-operative Exercise and the Response to Prehabilitation in Oesophageal Cancer Patients. Halliday, LJ., Doganay, E., Wynter-Blyth, V., et al.[2023]

Prehabilitation during neoadjuvant therapy for esophageal cancer significantly reduces the loss of skeletal muscle index (SMI) compared to patients who do not participate in prehabilitation, indicating its efficacy in preserving muscle mass.

Higher adherence to exercise in the prehabilitation group correlates with less decline in SMI and greater loss of visceral adipose tissue (VAT), which is associated with a lower risk of post-operative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of prehabilitation on body composition in patients undergoing multimodal therapy for esophageal cancer. Halliday, LJ., Boshier, PR., Doganay, E., et al.[2023]

Prehabilitation programs, particularly inspiratory muscle training (IMT), can improve functional status and reduce respiratory complications in patients undergoing esophagectomy or gastrectomy, based on a systematic review of 12 studies involving 937 patients.

Postoperative rehabilitation is associated with better clinical outcomes, suggesting that optimizing patient health before surgery may enhance recovery, although further large randomized controlled trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative prehabilitation and rehabilitation in esophagogastric malignancies: a systematic review. Bolger, JC., Loughney, L., Tully, R., et al.[2020]

Esophageal adenocarcinoma (EADC) rates have been rising rapidly in North America and Europe, with chronic gastroesophageal reflux disease and lifestyle factors like obesity and tobacco use identified as significant risk factors.

There is limited research on the relationship between physical activity and EADC, highlighting a gap in understanding how exercise may influence cancer risk, particularly in relation to obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, obesity and risk for esophageal adenocarcinoma. Balbuena, L., Casson, AG.[2009]

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]

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]

In a study of 54 patients with esophagogastric cancer, a 15-week prehabilitation program that included exercise and psychological coaching helped maintain peak oxygen uptake (peak VO2) better than usual care, with a significantly smaller decline in fitness post-neoadjuvant therapy.

Patients who underwent prehabilitation experienced less muscle loss and improved quality of life, and they were more likely to complete their neoadjuvant therapy at full dose, indicating that prehabilitation may enhance treatment adherence without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Prehabilitation During Neoadjuvant Therapy Prior to Esophagogastric Cancer Resection: Effect on Cardiopulmonary Exercise Test Performance, Muscle Mass and Quality of Life-A Pilot Randomized Clinical Trial. Allen, SK., Brown, V., White, D., et al.[2022]

Citations

1. 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.

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/PMC9939163/

Home‐based physical activity after treatment for ... The 12‐week, home‐based exercise program with resistance training showed an improvement in lower extremity muscle strength. Home‐based physical ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.12055

Randomized clinical trial on the effect of a supervised ... Patients were well capable to complete an intensive supervised exercise program after esophageal cancer treatment, which led to small but significant ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12318388/

Feasibility, safety and preliminary effect of exercise ... Guinan et al. reported that preoperative inspiratory muscle training alone did not significantly improve the 6MWD in patients with esophageal ...

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. sciencedirect.com sciencedirect.com/science/article/pii/S0748798325000034

The course of physical fitness and nutritional status in ... In conclusion, our study demonstrates the dynamic changes in physical fitness and nutritional status among patients with esophageal cancer undergoing curative ...