Esophageal Cancer Multimodal Prehabilitation Study

• ClinicalTrials.gov Identifier: NCT06027515
• Recruitment Status: Recruiting
• First Posted: September 7, 2023
• Last Update Posted: March 12, 2024
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Hassan Dashti, Massachusetts General Hospital

Tracking Information

• First Submitted Date: August 22, 2023
• First Posted Date: September 7, 2023
• Last Update Posted Date: March 12, 2024
• Actual Study Start Date: December 1, 2023
• Estimated Primary Completion Date: October 18, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2023)

• Enrollment Rate (Feasibility) [ Time Frame: At screening ]
  Number of eligible patients who enroll in study
• Completion Rate (Feasibility) [ Time Frame: 30 days ]
  Defined as the number of patients who complete study procedures.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 6, 2023)

• Nutrition Compliance Rate (Feasibility) [ Time Frame: 5 days ]
  Comparison of number of nutritional supplements consumed compared to number of nutritional supplements prescribed as determined from daily check-ins. A cut-off value of 80% will be used to indicate compliance.
• Physical Function Compliance Rate (Feasibility) [ Time Frame: 30 days ]
  Comparison of the total minutes of physical function completed compared to the total minutes of physical function prescribed as determined from daily check-ins and wearable device. A cut-off value of 80% will be used to indicate compliance.
• Sleep Health Compliance Rate (Feasibility) [ Time Frame: 30 days ]
  Comparison of the average daily hours of sleep duration, minutes of wake after sleep onset, and variability in sleep timing, achieved compared to prescribed as determined from actigraphy. A cut-off value of 80% will be used to indicate compliance.
• Actigraphy Compliance Rate (Feasibility) [ Time Frame: 30 days ]
  Total daily hours of actiwatch/wearable device wear-time. A cut-off value of 80% will be used to indicate compliance.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: September 6, 2023)

• Sarcopenia [ Time Frame: At baseline ]
  Assessed by baseline Computed Tomography (CT) scan of the thorax.
• Malnutrition [ Time Frame: At baseline visit and second measure at post-operative 1 day visit ]
  Assessed by the Perioperative Nutrition Screen (PONS) Risk Score, a modified version of the malnutrition universal screening tool, which determines the presence of nutrition risk based on BMI, recent body weight loss, decrement of dietary intake, and preoperative albumin concentration.
• Patient-Reported Sleep Measures [ Time Frame: At baseline visit and second measure at post-operative 1 day visit ]
  Assessed by the International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity.
• Hand Grip Test [ Time Frame: At baseline visit and second measure at post-operative 1 day visit ]
  Assessed by change in baseline and post-operative Hand Grip tests using a hand-held dynamometer. An average score is calculated using measurements from both hands.
• BMI [ Time Frame: At baseline visit and second measure at post-operative 1 day visit ]
  Assessed by change in baseline and post-operative height and weight.
• Energy expenditure [ Time Frame: At baseline visit and second measure at post-operative 1 day visit ]
  Assessed by change in baseline and post-operative Metabolic Cart, or indirect calorimetry.
• 6-Minute Walk Test [ Time Frame: At baseline visit and second measure at post-operative 1 day visit ]
  Assessed by a baseline and a post-operative 6-Minute Walk Test, a sub-maximal exercise test used to assess aerobic capacity and endurance.
• Patient-Reported Measures on Physical Function Score [ Time Frame: At baseline visit and second measure at post-operative 1 day visit ]
  Assessed by Activity Measure for Post-Acute Care (AM-PAC), a standardized assessment used to measure the physical function and functional status of patients. The AM-PAC consists of 13 tests that divided into lower and upper extremity function, gait and balance and activities of daily living and instrumental activities of daily living. Also assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), a 45-item self-reported measure to evaluate physical function.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Esophageal Cancer Multimodal Prehabilitation Study
• Official Title: A Multimodal Prehabilitation Feasibility Study for Older Adult Patients at High Risk for Poor Postoperative Outcomes Prior to Esophageal Cancer Surgery
• Brief Summary: 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.

Detailed Description

This research study is to test whether a novel, 4-week surgical multimodal prehabilitation protocol is feasible in at-risk older adult patients who have previously undergone neoadjuvant chemotherapy or radiotherapy and are scheduled for surgical removal of esophageal cancer.

Research study procedures include screening for eligibility, clinic visits, questionnaires, blood tests, and Computed Tomography (CT) scans.

Participation in this research study is expected to last 7 months.

It is expected about 30 patients will participate in this study.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Behavioral: Prehabilitation Program

Multimodal prehabilitation program consisting of pre-surgical optimization of nutrition, physical function, and sleep health via individualized plans. Participants will also be supplied with Nestle Impact Advances Recovery Immunonutrition Drink.

Study Arms

Experimental: Prehabilitation Program

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.

Intervention: Behavioral: Prehabilitation Program

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 6, 2023): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 31, 2026
• Estimated Primary Completion Date: October 18, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 65 years of age and over
• Adult male or non-pregnant female volunteers
• Completed neoadjuvant chemotherapy or radiotherapy for esophageal cancer
• At least four weeks to esophageal cancer surgery
• Without skin conditions that preclude wearing sensors
• Able to speak English and consent

Exclusion Criteria:

• Participants in any other interventional study that may bias results or limit study adherence during our study
• Dietary restrictions that prevent consumption of nutritional supplements
• Women who are pregnant, nursing, or at risk of becoming pregnant
• Profound physical disability (for example, quadriplegia) that precludes participation in any aerobic or strength training.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Hassan Dashti, PhD; 6177269132; Hassan.dashti@mgh.harvard.edu

Contact: Federico Ciardi, MBBS; 646-574-7682; fciardi@mgh.harvard.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06027515
• Other Study ID Numbers: 23-085
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• URL: http://www.partners.org/innovation

• Current Responsible Party: Hassan Dashti, Massachusetts General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Hassan Dashti, PhD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: March 2024