Clinical trial NCT06027515: 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
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Esophageal Neoplasms
Keywords: Esophageal Cancer
Esophageal Neoplasms
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Enrollment Rate (Feasibility)
timeFrame: At screening
measure: Completion Rate (Feasibility)
timeFrame: 30 days
Secondary outcomes:
measure: Nutrition Compliance Rate (Feasibility)
timeFrame: 5 days
measure: Physical Function Compliance Rate (Feasibility)
timeFrame: 30 days
measure: Sleep Health Compliance Rate (Feasibility)
timeFrame: 30 days
measure: Actigraphy Compliance Rate (Feasibility)
timeFrame: 30 days
Other outcomes:
measure: Sarcopenia
timeFrame: At baseline
measure: Malnutrition
timeFrame: At baseline visit and second measure at post-operative 1 day visit
measure: Patient-Reported Sleep Measures
timeFrame: At baseline visit and second measure at post-operative 1 day visit
measure: Hand Grip Test
timeFrame: At baseline visit and second measure at post-operative 1 day visit
measure: BMI
timeFrame: At baseline visit and second measure at post-operative 1 day visit
measure: Energy expenditure
timeFrame: At baseline visit and second measure at post-operative 1 day visit
measure: 6-Minute Walk Test
timeFrame: At baseline visit and second measure at post-operative 1 day visit
measure: Patient-Reported Measures on Physical Function Score
timeFrame: At baseline visit and second measure at post-operative 1 day visit
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Hassan Dashti, PhD
role: PRINCIPAL_INVESTIGATOR
References: