Back to resultsEsophageal Cancer Multimodal Prehabilitation Study
Primary Purpose
Esophageal Cancer, Esophageal Neoplasms
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prehabilitation Program
Sponsored by
About this trial
This is an interventional supportive care trial for Esophageal Cancer focused on measuring Esophageal Cancer, Esophageal Neoplasms
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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prehabilitation Program
Arm Description
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.
Outcomes
Primary Outcome Measures
Enrollment Rate (Feasibility)
Number of eligible patients who enroll in study
Completion Rate (Feasibility)
Defined as the number of patients who complete study procedures.
Secondary Outcome Measures
Nutrition Compliance Rate (Feasibility)
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)
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)
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)
Total daily hours of actiwatch/wearable device wear-time. A cut-off value of 80% will be used to indicate compliance.
Full Information
NCT ID
NCT06027515
First Posted
August 22, 2023
Last Updated
September 6, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06027515
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 18, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Esophageal Neoplasms
Keywords
Esophageal Cancer, Esophageal Neoplasms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation Program
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Prehabilitation Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enrollment Rate (Feasibility)
Description
Number of eligible patients who enroll in study
Time Frame
At screening
Title
Completion Rate (Feasibility)
Description
Defined as the number of patients who complete study procedures.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Nutrition Compliance Rate (Feasibility)
Description
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.
Time Frame
5 days
Title
Physical Function Compliance Rate (Feasibility)
Description
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.
Time Frame
30 days
Title
Sleep Health Compliance Rate (Feasibility)
Description
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.
Time Frame
30 days
Title
Actigraphy Compliance Rate (Feasibility)
Description
Total daily hours of actiwatch/wearable device wear-time. A cut-off value of 80% will be used to indicate compliance.
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Sarcopenia
Description
Assessed by baseline Computed Tomography (CT) scan of the thorax.
Time Frame
At baseline
Title
Malnutrition
Description
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.
Time Frame
At baseline visit and second measure at post-operative 1 day visit
Title
Patient-Reported Sleep Measures
Description
Assessed by the International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity.
Time Frame
At baseline visit and second measure at post-operative 1 day visit
Title
Hand Grip Test
Description
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.
Time Frame
At baseline visit and second measure at post-operative 1 day visit
Title
BMI
Description
Assessed by change in baseline and post-operative height and weight.
Time Frame
At baseline visit and second measure at post-operative 1 day visit
Title
Energy expenditure
Description
Assessed by change in baseline and post-operative Metabolic Cart, or indirect calorimetry.
Time Frame
At baseline visit and second measure at post-operative 1 day visit
Title
6-Minute Walk Test
Description
Assessed by a baseline and a post-operative 6-Minute Walk Test, a sub-maximal exercise test used to assess aerobic capacity and endurance.
Time Frame
At baseline visit and second measure at post-operative 1 day visit
Title
Patient-Reported Measures on Physical Function Score
Description
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.
Time Frame
At baseline visit and second measure at post-operative 1 day visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hassan Dashti, PhD
Phone
6177269132
Email
Hassan.dashti@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Federico Ciardi, MBBS
Phone
646-574-7682
Email
fciardi@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Dashti, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hassan Dashti, PhD
Phone
617-726-9132
Email
Hassan.dashti@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Federico Ciardi, MBBS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation
IPD Sharing URL
http://www.partners.org/innovation
Learn more about this trial
Esophageal Cancer Multimodal Prehabilitation Study
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