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Completed

NCT Number: NCT06027515

Esophageal Cancer Multimodal Prehabilitation Study

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prehabilitation program

Behavioral

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 outcomes

  1. Enrollment Rate (Feasibility)

    Time frame: At screening

    Number of eligible patients who enroll in study

  2. Completion Rate (Feasibility)

    Time frame: 30 days

    Defined as the number of patients who complete study procedures.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. Sarcopenia

    Time frame: At baseline

    Assessed by baseline Computed Tomography (CT) scan of the thorax.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

A Multimodal Prehabilitation Feasibility Study for Older Adult Patients at High Risk for Poor Postoperative Outcomes Prior to Esophageal Cancer Surgery

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 7, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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