ClinicalTrials.gg
RecruitingNCT07638410Updated Sep 21, 2026

Prehabilitation in High-risk Oncologic Surgery

An interventional study of Multidisciplinary Prehabilitation Program in Pancreatic Cancer, Colo-rectal Cancer and Gastric Cancer, sponsored by Fox Chase Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Fox Chase Cancer Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Pancreatic Neoplasms by Fox Chase Cancer Center — 1 open to participants now, 3 under way, none of them phase 3. Pancreatic Neoplasms · Fox Chase Cancer Center.

Planned enrollment
2nd of 10
180 · median 30
Started
2026
the only one that year
No phase
3 of 11
1 open now
Registered
11th of 11
by date

Among the 11 studies in Pancreatic Neoplasms by Fox Chase Cancer Center, this one is the 2nd largest by planned enrollment of the 10 interventional ones, is the only one that started in 2026, is one of 3 with no phase, and was the 11th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

Phase 14 · 0 open
No phasethis study3 · 1 open
Phase 22 · 0 open
Observational1 · 0 open
Phase 41 · 0 open

By the year they started

First in 2000; this study’s year is marked. 1 started in 2026.

Size and results

Median enrollment 30 across the 10 interventional studies, 37 across the 1 observational. Of the 8 that completed or were terminated, 3 (38%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies in Pancreatic Neoplasms by Fox Chase Cancer Center, or all of them as a file.
02

Study summary

The goal of this clinical study is to learn whether a prehabilitation program can improve recovery after major abdominal surgery in adults with cancer who are receiving treatment before surgery. Prehabilitation is supportive care given before surgery to help patients prepare physically, nutritionally, and emotionally.

The main questions this study aims to answer are:

  1. Does prehabilitation reduce the number of participants who die or have serious complications within 30 days after surgery?
  2. Does prehabilitation improve physical strength and fitness, nutritional status, emotional well-being, and quality of life before surgery?
  3. Does prehabilitation affect the length of the hospital stay after surgery, the time it takes to start additional cancer treatment after surgery, or the ability to complete recommended additional treatment?

Participants will take part in a prehabilitation program during their treatment period before surgery. The program includes visits with physical therapy, nutrition, and health psychology. Participants will meet with each specialty at least twice before surgery. They will also complete questionnaires and tests that measure physical function, diet and weight, emotional well-being, and quality of life. After surgery, information about recovery and additional cancer treatment will be collected from medical records for up to 120 days.

Researchers will compare the outcomes of participants who receive the prehabilitation program with outcomes from similar patients who previously received care at Fox Chase Cancer Center but did not participate in this study.

Read the detailed description

Patients with cancer who receive treatment before major abdominal surgery may experience loss of strength, reduced nutritional status, fatigue, and emotional distress during the period leading up to surgery. These challenges may affect their ability to tolerate surgery and recover after the procedure. Prehabilitation is an approach intended to improve a patient's condition before surgery through coordinated supportive care.

This is a prospective cohort study evaluating a multidisciplinary prehabilitation program for adults with cancer who are undergoing neoadjuvant treatment before planned high-risk abdominal oncologic surgery. The program integrates physical therapy, nutritional support, and health psychology during the preoperative treatment period. The study will evaluate whether this approach is associated with improved postoperative outcomes and improved measures of physical function, nutritional status, and emotional well-being.

Outcomes for participants enrolled in the prospective prehabilitation cohort will be compared with outcomes from matched retrospective controls treated at Fox Chase Cancer Center before initiation of this study. Each prospective participant who proceeds to surgery and is eligible for analysis will be matched with one retrospective control based on relevant clinical and demographic characteristics, including age, sex, smoking status, American Society of Anesthesiologists (ASA) class, and cancer type. When more than one eligible matched control is available, one control will be selected at random.

The study is intended to assess whether a structured, multidisciplinary prehabilitation program can be implemented across several high-risk oncologic surgery populations and whether this approach may support improved recovery and continuity of cancer care after surgery.

03

Conditions studied

  • Pancreatic Cancer
  • Colo-rectal Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • Bladder Cancer
  • Ovarian Cancer
  • Abdominal Surgery Complications

Keywords

  • Prehabilitation
  • Preoperative Rehabilitation
  • Multimodal Prehabilitation
  • Major Abdominal Surgery
  • Oncologic Surgery
  • Neoadjuvant Therapy
  • Postoperative Complications
  • Cancer Surgery
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Evidence of probable or confirmed primary or recurrent malignant neoplasm of any stage
  • Planned to undergo chemotherapy or chemoradiation
  • Eligible surgical candidate for one of the following procedures: pancreatectomy, gastrectomy, esophagectomy, cystectomy, low anterior resection, abdominoperineal resection, or cytoreductive surgery with heated intraperitoneal chemotherapy
  • Age greater than 18 years
  • (ECOG) performance status of 0 to 2
  • Ability to understand and willingness to sign a written form and Health Insurance Portability and Accountability Act (HIPAA) authorization document

Exclusion criteria

Exclusion Criteria:

  • Unable to complete study requirements, such as attending a minimum of two visits for each specialty referral. This will be assessed at the final preoperative visit, at which time the participant may be discontinued from the study and replaced. Participants will not be excluded due to lack of insurance coverage for health psychology visits.
  • Does not proceed to surgery at an affiliated institution
  • Pregnant or breastfeeding
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Multidisciplinary Prehabilitation Program

    Participants will receive a multidisciplinary prehabilitation program during the preoperative period while undergoing neoadjuvant treatment before planned high-risk abdominal oncologic surgery. The program includes supportive care provided by physical therapy, nutrition, and health psychology to prepare participants for surgery and support physical, nutritional, and emotional well-being.

    Behavioral: Multidisciplinary Prehabilitation Program

Interventions

  • BehavioralMultidisciplinary Prehabilitation Program

    A multidisciplinary prehabilitation program delivered during neoadjuvant therapy before planned high-risk abdominal oncologic surgery. The program includes physical therapy, nutrition, and health psychology support, with approximately monthly visits and at least two visits with each specialty before surgery. Physical therapy includes an individualized home strengthening and aerobic exercise program supported by resistance bands, a pedometer, and an exercise log. Nutrition includes individualized dietary counseling focused on maintaining weight and meeting protein needs, with oral nutritional supplementation when clinically indicated. Health psychology includes assessment, supportive care planning, and referral to additional psychosocial resources when needed. The intervention is completed before surgery; postoperative data collection is for follow-up only.

06

What researchers measure

Primary outcomes

  1. 30-Day Rate of Death or Serious Complications After Surgery

    Percentage of participants who experience death or at least one serious postoperative complication within 30 days after the index surgery, as defined by the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP). Outcomes in participants receiving the multidisciplinary prehabilitation program will be compared with outcomes in matched retrospective controls.

    Time frame: Within 30 days after surgery

Secondary outcomes

  1. 30-Day Death or Serious Complications by Surgical Cohort

    Incidence of 30-day death or serious complications (DSC) among participants undergoing partial or complete pancreatectomy, low anterior resection or abdominoperineal resection, esophagectomy or major gastrectomy, cystectomy, cytoreductive surgery with HIPEC, or other major oncologic procedures. Outcomes will be compared with matched retrospective controls.

    Time frame: 30 days after surgery

  2. Change in Physical Function, Nutritional Status, and Emotional Well-Being

    Assessment of the effect of prehabilitation on physical fitness, nutritional status, and emotional well-being, including grip strength, 30-second sit-to-stand test performance, gait speed or 2-minute walk test completion, resting heart rate, skeletal muscle mass-to-height ratio, body weight, Healthy Eating Index score assessed using Vioscreen, Patient Health Questionnaire-9 (PHQ-9) score, Generalized Anxiety Disorder-7 (GAD-7) questionnaire score, and Patient-Reported Outcomes Measurement Information System 29-item Profile (PROMIS-29) score.

    Time frame: Baseline through final preoperative evaluation (up to 6 months before surgery)

  3. Postoperative Surgical and Oncologic Outcomes

    Evaluation of postoperative outcomes including primary surgical admission length of stay, time to initiation of adjuvant therapy, and rate of completion of recommended adjuvant therapy compared with matched retrospective controls.

    Time frame: From surgery through 120 days after surgery

07

Study locations

1 of 1 sites recruiting
  • Fox Chase Cancer Center - Philadelphia
    Philadelphia, Pennsylvania 19111-2497, United States
    Recruiting
    • Henkel Valentine, PhD · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07638410
Responsible party
Sponsor
First posted
Jun 10, 2026
Start date
Jul 15, 2026
Primary completion
Dec 15, 2029 (estimated)
Completion
Mar 15, 2030 (estimated)
Last update
Sep 21, 2026

Study contacts

Stephanie Greco, MD
Contact
stephanie.greco@fccc.edu
2152143719
Henkel Valentine, PhD
Contact
henkel.valentine@fccc.edu
2678820820
Stephanie Gzreco, MD
principal investigator · Fox Chase Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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