Prehabilitation Program for Esophageal Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Hassan Dashti, PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this research study is to investigate the feasibility of implementing a prehabilitation program that aims to improve a patient's physical, nutritional, and sleep health before surgery in an older, at-risk group with esophageal cancer.

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 data supports the effectiveness of the treatment Prehabilitation Program for Esophageal Cancer?

Research shows that prehabilitation programs, which include exercise and conditioning before surgery, can improve fitness and reduce complications after surgery for esophageal cancer. These programs have been found to enhance exercise capacity, muscle strength, and overall recovery, making patients better prepared for surgery and improving their tolerance to treatments like chemotherapy.

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Is the Prehabilitation Program for Esophageal Cancer safe for humans?

Research on prehabilitation programs, including those for esophageal cancer, suggests they are generally safe and can improve fitness and reduce complications after surgery.

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How is the Prehabilitation Program treatment for esophageal cancer different from other treatments?

The Prehabilitation Program is unique because it focuses on improving patients' physical fitness before surgery through exercise, which can help reduce complications and improve recovery, unlike traditional treatments that focus solely on surgery and medication.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Massachusetts General Hospital Boston, MA

Who Is Running the Clinical Trial?

Massachusetts General Hospital Lead Sponsor

References

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

Adherence to Pre-operative Exercise and the Response to Prehabilitation in Oesophageal Cancer Patients. [2023] Prehabilitation is thought to reduce post-operative respiratory complications by optimising fitness before surgery. This prospective, single-centre study aimed to establish the effect of pre-operative exercise on cardiorespiratory fitness in oesophageal cancer patients and characterise the effect of adherence and weekly physical activity on response to prehabilitation.

2. England 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. [2021] Substantial postoperative complications occur after tumor resection for esophagogastric cancers. Physical prehabilitation programs aim to prepare patients for surgery by improving their functional status with the aim of reducing postoperative complications. This systematic review aims to summarize the effects of physical prehabilitation programs on exercise capacity, muscle strength, respiratory muscle function, postoperative outcomes, and health-related quality of life and to determine the optimal design of such a program to improve these outcomes in esophagogastric cancer patients undergoing tumor resection.

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

Pilot Prehabilitation Program for Patients With Esophageal Cancer During Neoadjuvant Therapy and Surgery. [2019] Locally advanced esophageal cancer is often treated with neoadjuvant therapy followed by surgery. Many patients present with or experience clinical deconditioning during neoadjuvant therapy. Prehabilitation programs in other areas of surgery have demonstrated improved postoperative outcomes. The aims of this study were to evaluate the feasibility of a pilot prehabilitation program and determine preliminary effects on surgical and cancer-related outcomes.

4. 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] To evaluate the effects of unimodal or multimodal prehabilitation on patients undergoing surgery for esophagogastric cancer.

5. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized Prehabilitation Improves Tolerance to Chemotherapy in Patients with Oesophageal Cancer. [2023] Prehabilitation programmes aim to optimise patients before and after cancer treatment including surgery. Previous studies in surgical patients demonstrate that prehabilitation improves pre-operative fitness and overcomes the negative impact of neoadjuvant chemotherapy on fitness. The aim of this study was to assess the impact of prehabilitation on the tolerance of neoadjuvant chemotherapy in patients with oesophageal cancer.

6. Japan pubmed.ncbi.nlm.nih.gov

Efficacy of enhanced prehabilitation for patients with esophageal cancer undergoing esophagectomy. [2022] Several studies have demonstrated that prehabilitation helps reduce the incidence of postoperative complications. In this study, we investigated the safety and efficacy of enhanced prehabilitation (EP) in the hospital for patients with esophageal cancer.

7. England pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023] Prehabilitation programs focusing on exercise training as the main component are known as a promising alternative for improving patients' outcomes before cancer surgery. This systematic review determined the benefits and harms of prehabilitation programs compared with usual care for individuals with cancer.