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

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 3 5 7}

Research Team

Hassan Dashti, PhD

Principal Investigator

Massachusetts General Hospital

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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Adherence to Pre-operative Exercise and the Response to Prehabilitation in Oesophageal Cancer Patients. [2023]

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]

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

Pilot Prehabilitation Program for Patients With Esophageal Cancer During Neoadjuvant Therapy and Surgery. [2019]

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]

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

Personalized Prehabilitation Improves Tolerance to Chemotherapy in Patients with Oesophageal Cancer. [2023]

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

Efficacy of enhanced prehabilitation for patients with esophageal cancer undergoing esophagectomy. [2022]

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

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023]