Prehabilitation Program for Esophageal Cancer

Overseen By Federico Ciardi, MBBS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Other study, Dietary restrictions, Pregnancy, Profound disability

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

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program designed to help older adults with esophageal cancer prepare for surgery. It aims to improve physical fitness, nutrition, and sleep to enhance recovery chances. Participants will follow daily exercise, diet, and sleep routines, and take a special nutritional supplement for a few days. This trial suits those who have completed chemotherapy or radiation treatment and are scheduled for surgery in a month or more. As an unphased trial, it offers a unique opportunity to enhance recovery through comprehensive pre-surgery preparation.

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 study team or your doctor.

What prior data suggests that this prehabilitation program is safe for esophageal cancer patients?

Research has shown that preparing for surgery with activities like exercise, good nutrition, and support is generally safe for patients. Studies have found that this preparation, known as prehabilitation, can improve recovery without causing major side effects. For example, one study found that prehabilitation reduced the risk of complications after surgery for patients with upper gastrointestinal cancers. Another study noted that while prehabilitation for esophageal cancer is still new, it did not cause more problems after surgery. Overall, prehabilitation appears to be well-tolerated and beneficial for patients preparing for surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Prehabilitation Program for esophageal cancer because it focuses on preparing patients for surgery rather than treating cancer directly. Unlike standard treatments like chemotherapy or surgery alone, this program emphasizes improving patients' physical fitness, nutrition, and sleep before surgery. By empowering patients to follow personalized health recommendations and providing support through telehealth and regular check-ins, the program aims to enhance recovery and outcomes post-surgery. This proactive approach could lead to fewer complications and a quicker recovery, offering a new dimension of care for esophageal cancer patients.

What evidence suggests that this prehabilitation program is effective for esophageal cancer?

Studies have shown that prehabilitation, or preparing for surgery, can improve recovery. For patients with upper gastrointestinal (GI) cancer, this preparation has significantly reduced post-surgery complications. One study found that it also helped patients leave the hospital sooner after their operations. However, using prehabilitation specifically for esophageal cancer remains new, and it has not yet shown a significant effect on reducing post-surgery issues. This trial will focus on a Prehabilitation Program for esophageal cancer patients to explore its potential benefits. Overall, evidence suggests that prehabilitation might enhance recovery for surgical patients, but more research is needed for esophageal cancer specifically. ^{1 2 3 5 6}

Who Is on the Research Team?

Hassan Dashti, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 65 and over with esophageal cancer, who have completed neoadjuvant therapy and are awaiting surgery. They must be able to participate in physical activities and not have skin issues that interfere with sensor use. Pregnant women or those in other studies are excluded.

Inclusion Criteria

You do not have any skin conditions that would prevent you from wearing sensors.

I have finished treatment before surgery for esophageal cancer.

My esophageal cancer surgery is scheduled in at least 4 weeks.

Exclusion Criteria

I have a severe physical disability that prevents me from doing any form of exercise.

Participants in any other interventional study that may bias results or limit study adherence during our study

I am not pregnant, nursing, or at risk of becoming pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Prehabilitation

Participants undergo a 4-week multimodal prehabilitation program including physical, nutritional, and sleep health interventions

4 weeks

Regular electronic/phone-call check-ins, telehealth appointment

Surgery and Immediate Postoperative Care

Participants undergo esophageal cancer surgery and receive assessments and questionnaires during hospital admission

1 week

In-person assessments during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after surgery, including a 6-month follow-up period

6 months

Final visit with dietitian and physical therapist, completion of questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Prehabilitation Program

Trial Overview

The study tests a prehabilitation program designed to boost patients' fitness, nutrition, and sleep before their esophageal cancer surgery. It aims to see if this approach is practical for older patients at higher risk due to their condition.

How Is the Trial Designed?

Group I: Prehabilitation Program Experimental Treatment 1 Intervention

30 participants will be enrolled and will complete study procedures as follows: * Enrollment at least 4 weeks prior to esophageal cancer surgery. * In-person clinic visit with dietitian and physical therapist for assessments, and completion of baseline questionnaires with study coordinator. * Adherence to daily physical function, dietary, and sleep recommendations and consumption of 5-day immunonutrition supplement. * Regular electronic/phone-call check-ins with study staff. * Telehealth appointment with physical therapist and dietitian prior to surgery. * After surgery and during hospital admission, final visit with dietitian and physical therapist for assessments, and completion of questionnaires. * 6-month follow-up period.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

A pilot prehabilitation program for patients with locally advanced esophageal cancer was found to be feasible and well-received, potentially reducing the need for hospital admissions during neoadjuvant therapy (27.3% vs. 54.5% in the control group).

Patients in the prehabilitation group experienced less weight loss during treatment (3.0% vs. 4.3%) and had lower postoperative readmission rates (0.0% vs. 18.2% within 30 days), suggesting that prehabilitation may improve surgical outcomes, although the small sample size limits statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Prehabilitation Program for Patients With Esophageal Cancer During Neoadjuvant Therapy and Surgery. Dewberry, LC., Wingrove, LJ., Marsh, MD., et al.[2019]

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]

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]

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]

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]

Enhanced prehabilitation (EP) for patients with esophageal cancer significantly improved preoperative and postoperative exercise tolerance, as shown by higher 6-minute walk distances compared to the control group (492.9 m vs. 418.9 m preoperatively).

EP also led to a notable reduction in respiratory complications, with only 4.3% of patients experiencing issues compared to 36% in the control group, and completely eliminated the incidence of atelectasis in the EP group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of enhanced prehabilitation for patients with esophageal cancer undergoing esophagectomy. Akiyama, Y., Sasaki, A., Fujii, Y., et al.[2022]

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

Citations

1.

aoe.amegroups.org

aoe.amegroups.org/article/view/5580/html

The impact of prehabilitation on surgical outcomes - Minnella

Prehabilitation for esophageal cancer is in its infancy, and to date has not shown any significant impacts on postoperative morbidity.

2.

pmc.ncbi.nlm.nih.gov

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

Feasibility, safety and preliminary effect of exercise ...

Increasing evidence underscores the effectiveness of prehabilitation in improving postoperative outcomes in patients with cancer.

3.

jamanetwork.com

jamanetwork.com/journals/jamasurgery/fullarticle/2698681

Effect of Exercise and Nutrition Prehabilitation on ...

Main Outcomes and Measures The primary outcome was change in functional capacity, measured with absolute change in 6-minute walk distance (6MWD ...

4.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0315734

The impact of prehabilitation on upper gastrointestinal cancer ...

The pooled results indicated that prehabilitation significantly reduced the overall postoperative complication rates in patients with upper GI cancer undergoing ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12452279/

Effect of prehabilitation on postoperative outcomes in patients ...

The results show that prehabilitation significantly reduced the postoperative length of hospital stay (standardized mean difference (SMD) −0.27) ...

6.

mdpi.com

mdpi.com/2072-6694/17/11/1836

The Impact of Prehabilitation on Patient Outcomes in ...

This study examined the effects of prehabilitation—structured exercise, nutrition and psychological support before surgery—on patients with oesophagogastric ...