Esophageal CancerNCT06027515
Esophageal Cancer Multimodal Prehabilitation Study
A study testing Prehabilitation Program in people with Esophageal Cancer and Esophageal Neoplasms, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Esophageal Cancer, Esophageal Neoplasms
- What is being tested?
- Prehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
Official title: A Multimodal Prehabilitation Feasibility Study for Older Adult Patients at High Risk for Poor Postoperative Outcomes Prior to Esophageal Cancer Surgery
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.
Read the 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.
- Conditions
- Esophageal Cancer, Esophageal Neoplasms
- Being tested
- Prehabilitation Program
- Keywords
- Esophageal Cancer, Esophageal Neoplasms
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| Prehabilitation Program | Experimental | 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. Receives: Behavioral: Prehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate (Feasibility)
Number of eligible patients who enroll in study
Measured: At screening
Completion Rate (Feasibility)
Defined as the number of patients who complete study procedures.
Measured: 30 days
Secondary outcomes (4)
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.
Measured: 5 days
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.
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Dec 2023
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Dashti, Massachusetts General Hospital
- Investigators
- Hassan Dashti, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027515
- Sponsor's protocol ID
- 23-085
- Status last verified
- Feb 2026
- First submitted
- 22 Aug 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Prehabilitation Feasibility Study for Older Adult Patients at High Risk for Poor Postoperative Outcomes Prior to Esophageal Cancer Surgery
- ClinicalTrials.gov ID
- NCT06027515
- Acronym / sponsor ID
- 23-085
- Conditions
- Esophageal Cancer, Esophageal Neoplasms
- Keywords
- Esophageal Cancer, Esophageal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation Program | Experimental | Behavioral: Prehabilitation Program30 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation ProgramMultimodal 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. | Behavioural | Prehabilitation Program |
Primary outcome
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.
4 secondary outcomes
Nutrition Compliance Rate (Feasibility)
Time frame: 5 days
Physical Function Compliance Rate (Feasibility)
Time frame: 30 days
Sleep Health Compliance Rate (Feasibility)
Time frame: 30 days
Actigraphy Compliance Rate (Feasibility)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Dashti, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation Program in people with Esophageal Cancer and Esophageal Neoplasms, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (Feasibility) (time frame: At screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.