Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06027515
Other study ID # 23-085
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date January 31, 2026

Study information

Verified date March 2024
Source Massachusetts General Hospital
Contact Hassan Dashti, PhD
Phone 6177269132
Email Hassan.dashti@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 31, 2026
Est. primary completion date October 18, 2025
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Sarcopenia Assessed by baseline Computed Tomography (CT) scan of the thorax. At baseline
Other Malnutrition 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. At baseline visit and second measure at post-operative 1 day visit
Other Patient-Reported Sleep Measures Assessed by the International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity. At baseline visit and second measure at post-operative 1 day visit
Other Hand Grip Test 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. At baseline visit and second measure at post-operative 1 day visit
Other BMI Assessed by change in baseline and post-operative height and weight. At baseline visit and second measure at post-operative 1 day visit
Other Energy expenditure Assessed by change in baseline and post-operative Metabolic Cart, or indirect calorimetry. At baseline visit and second measure at post-operative 1 day visit
Other 6-Minute Walk Test Assessed by a baseline and a post-operative 6-Minute Walk Test, a sub-maximal exercise test used to assess aerobic capacity and endurance. At baseline visit and second measure at post-operative 1 day visit
Other Patient-Reported Measures on Physical Function Score 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. At baseline visit and second measure at post-operative 1 day visit
Primary Enrollment Rate (Feasibility) Number of eligible patients who enroll in study At screening
Primary Completion Rate (Feasibility) Defined as the number of patients who complete study procedures. 30 days
Secondary 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. 5 days
Secondary 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. 30 days
Secondary 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. 30 days
Secondary 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. 30 days
See also
  Status Clinical Trial Phase
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
Not yet recruiting NCT05542680 - Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer N/A
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Completed NCT00003864 - Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus Phase 2
Recruiting NCT05491616 - Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Completed NCT00199849 - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Phase 1
Completed NCT03756597 - PAN-study: Pan-Cancer Early Detection Study (PAN)
Completed NCT00400114 - Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT04615806 - The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy N/A
Active, not recruiting NCT04566367 - Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer N/A
Active, not recruiting NCT03962179 - Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent) N/A
Terminated NCT01446874 - Prevention of Post-operative Pneumonia (POPP) Phase 2/Phase 3
Completed NCT03468634 - Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy N/A
Active, not recruiting NCT02869217 - Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors Phase 1
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT01404156 - Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma Phase 2/Phase 3