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Esophageal CancerNCT06872515

Impact of Prehabilitation in Oncology Via Exercise- Esophageal (IMPROVE-Esophageal)

A study testing Exercise and Nutrition in people with Esophageal Cancer and Esophageal Carcinoma, run by University of Pittsburgh at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this study is to determine the feasibility of a prehabilitation exercise and nutrition program (exercise and nutrition before a medical treatment) in adults with esophageal cancer before surgery (esophagectomy). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer, Esophageal Carcinoma
What is being tested?
Exercise and Nutrition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
16 Jul 2025to 1 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women, age ≥ 18 years old
  • Diagnosed with esophageal cancer
  • Identified as esophagectomy surgery candidates at Hillman Cancer Center, UPMC Shadyside, or UPMC Passavant
  • ≥ 2 weeks until scheduled esophagectomy
  • ECOG Performance Status Scale score of ≤ 2
  • Ability to provide written informed consent
  • Ability to understand, speak, and read English.

Who cannot join

  • Evidence in the medical record of an absolute contraindication for exercise (e.g., Heart insufficiency > NYHA III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability)
  • Any other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist
  • Receiving non-esophagectomy related chemotherapy and/or radiotherapy
  • Active infections, hemorrhages, and cytopenias that could place surgical patients at risk for further adverse events, deemed by the exercise interventionist, physician, and/or nurse

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cara Battistella, MA contact

412-353-9102

battistellac@upmc.edu

United States1 site, 1 recruiting
  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15213

    Cara Battistella, 412-353-9102, battistellac@upmc.edu

    Recruiting

Other trials in United States

About this study

Official title: Impact of Prehabilitation in Oncology Via Exercise- Esophageal

The goal of this study is to determine the feasibility of a prehabilitation exercise and nutrition program (exercise and nutrition before a medical treatment) in adults with esophageal cancer before surgery (esophagectomy). The pre-surgery exercise and nutrition program will include resistance and aerobic training and nutrition supplementation during the weeks before surgery. We will also assess pre-surgical care needs in adults with esophageal cancer. Researchers will compare the exercise and nutrition intervention to usual care- which is standard medical care and post-surgery surveillance/follow-up to understand the impact of exercise and nutrition before surgery. We will follow-up with participants before surgery, and after surgery at 2 weeks, 6 weeks, and 4-months at appointments that coincide with clinical follow-ups.

The main questions of this trials are:

  • Is exercise and nutrition supplementation before surgery for esophageal cancer feasible and acceptable to patients?
  • How does exercise and nutrition supplementation before surgery change physical function and psychosocial health?
  • What are important pre-surgical needs for adults with esophageal cancer?
Being tested
Exercise and Nutrition, Usual Care Group
Keywords
Prehabilitation, Exercise, Esophageal cancer, Neoadjuvant chemotherapy, Pre-surgical exercise
Medical subject headings
Esophageal Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise and NutritionBehavioural

    The exercise and nutrition intervention will last up to 8 weeks and will include:

    • 3-5 times per week of resistance training and 3-5 times per week of aerobic training. The prescribed exercise will be personalized based on the participant's baseline functionality.
    • Ensure Complete nutrition supplement drinks: 2 per day starting on the same day the exercise begins, up until 5 days prior to surgery.
  • Usual Care GroupBehavioural

    The CONT group will not receive any intervention during study participation and undergo usual medical treatment and surveillance during the duration of the study.

Study groups in NCT06872515
Study groupRoleWhat they receive
Home-based prehabilitation exercise and nutrition (PRE)ExperimentalInterventions will include: * Up to 8 weeks of 3-5 times per week resistance training and 3-5 times per week of aerobic training. * Ensure Complete nutrition supplement drinks: 2 per day starting on the same day the exercise begins, up until 5 days prior to surgery.
Receives: Behavioral: Exercise and Nutrition
Usual Care (CONT)Active comparatorThe CONT group will not receive any intervention during study participation and undergo usual medical treatment and surveillance during the duration of the study.
Receives: Behavioral: Usual Care Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability of Intervention

    Acceptability is defined as the proportion of approached participants who agree to participate and complete the baseline assessments and be randomized.

    Measured: From enrollment through surgical admission, up to 8 weeks

  2. Adherence to Intervention

    Exercise adherence will be calculated as the proportion of completed exercise sessions over the number of prescribed sessions.

    Measured: From enrollment through surgical admission, up to 8 weeks

  3. Feasibility of Intervention

    The intervention will be considered feasible if 50% of participants complete approximately 70% of prescribed prehabilitation sessions prior to their surgical admission.

    Measured: From enrollment through surgical admission, up to 8 weeks

Secondary outcomes (23)
  1. Six-minute walk test (6MWT)

    Cardiorespiratory fitness will be measured using the six minute walk test. The 6MWT is an objective evaluation of functional exercise capacity. Its results are highly correlated with those of the 12-minute walk test from which it was derived and with those of cycle ergometer or treadmill-based exercise tests.

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  2. 2-Minute Step Test

    Cardiorespiratory fitness will be measured with the 2-minute step test. Participants will be marching in place for 2 minutes and are encouraged to use a chair for balance or do the assessment seated if standing is too difficult. They should be lifting their legs about 6 inches off the ground, as if they were stepping onto a curb from the road. The tester will count the number of times the participant raises their right leg off the ground.

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  3. 30-second chair stand test (30CST)

    Lower body strength will be evaluated using the 30 second chair stand test. The participant is seated in the middle of the chair, back straight, feet approximately shoulder width apart and placed on the floor. Arms are crossed at the wrists and held against the chest. At the signal "go," the participant rises to a full body stand and then returns to the initial seated position. The participant is encouraged to complete as many full stands as possible within 30 seconds.

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  4. Timed-Up-and-Go (TUG) test

    The TUG evaluates lower body strength, balance, and agility. The patient sits in a chair and on the command "go", the patient rises from the chair, walks 3 meters at a self-selected pace, turns around an obstacle, walks back to the chair and sits down. Test results may also be quantified assessing the time (seconds) needed to complete the assessment.

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  5. Frail Scale

    The FRAIL Scale is a short, five item assessment designed to identify frailty without face-to-face administration. The questions address Fatigue, Resistance, Ambulation, Illness, and Loss of weight (FRAIL). Scores range from 0 (robust heath status) to 5 (frail) with an intermediate category for pre-frail. Research has shown that within the geriatric fracture population, higher scores on this assessment have been shown to be associated with increased length of hospitalization, surgical complications, and more likely discharge to a rehabilitation facility rather than home making it a helpful short screen to gauge risk in the surgical population.

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  6. Handgrip assessment

    Maximum capacity to squeeze with each hand may be assessed using a hand grip dynamometer. Each hand may be assessed three times.

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  7. Short Physical Performance Battery (SPPB)

    The SPPB is a short battery of performance tests of lower extremity functioning. The tests measure gait speed, standing balance, and lower extremity strength and power. To test gait speed, patients are instructed to walk an 8-foot walking course at their usual pace with assistive devices if needed. Four progressively more challenging positions are used to test balance (bipedal [feet next to each other], semi-tandem [one foot slightly in front of the other], and full tandem [one foot in front of the other]). To test lower extremity strength, patients are asked to stand up and sit down five times as quickly as possible and are timed from the initial sitting position to the final standing position at the end of the fifth stand.

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  8. Actigraph accelerometry

    Physical activity may be measured objectively using wearable accelerometry. Accelerometer data will include estimated average metabolic equivalents expended daily and in hours/week as well as time in sedentary, low, moderate, and vigorous activity.

    Measured: Baseline, 2 Weeks post esophagectomy, and 4 Months post esophagectomy

  9. SARC-F Sarcopenia scale

    The SARC-F questionnaire is a short 5-item battery containing observational assessments that is a rapid diagnostic test for sarcopenia. There are 5 SARC-F components: Strength, Assistance with walking, Rise from a chair, Climb Stairs, and Falls.

    Min = 0; Max = 10; higher score = higher risk for sarcopenia

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  10. Carbon Monoxide (CO) assessment

    Expired carbon monoxide will be evaluated using a CO analyzer (coVita Smokerlyzer Breath CO Test). The CO assessment is a rapid and noninvasive method quantify CO in the blood and illustrate current smoking habits.

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  11. Edmonton Frail Scale (EDS)

    The Edmonton Frail Scale is a reliable measure for frailty that is easy to use, captures the multidimensional aspects of fatigue, and presents the level of frailty along a continuum so that change over time can be captured. The semi-structured interview collects data across 9 frailty domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance. Scores fall within one of 5 categories (not frail, vulnerable, mild frailty, moderate frailty, severe frailty) and range from 0 (not frail) to 17 (severe frailty).

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  12. Demographics

    Demographics may be collected at baseline via self-reported survey. These include date of birth, education, income, zip code, and household composition.

    Measured: Baseline

  13. Injury History Survey (EX Cohort only)

    Developed to assess injuries as well as discomfort from exercise. This survey will be administered to the EX cohort at the end of the intervention period at timepoint T1.

    Measured: Time of Admission

  14. EORTC QLQ-C30 Quality of Life (QoL)

    QoL may be assessed with the validated 30-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It includes five multi- item functional scales (physical, role, emotional, cognitive, and social function), three multi-item symptom scales (fatigue, pain, nausea/vomiting), and six single items assessing further symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) and financial difficulties. Scores are derived according to the EORTC scoring manual.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  15. Multidimensional Fatigue Inventory

    Fatigue may be assessed with the Multidimensional Fatigue Inventory (MFI) which is a 20-item, multidimensional self-assessment questionnaire. It covers five different dimensions of fatigue (general, physical, reduced activity, reduced motivation, and mental). Scores are derived by summing the answers (five-stage scale) of the appropriate items.

    Min = 20; Max = 100; higher score = less fatigue

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  16. Godin Leisure Time Exercise

    Physical activity patterns during a patient's leisure time may be assessed using the Godin Leisure Time Exercise questionnaire. The questionnaire asks patients to recall, during a seven-day period, the frequency to which they participated in strenuous, moderate, and mild exercise. The Godin questionnaire is short and easy to complete.

    Min = 0; Max = none; higher score = more activity

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  17. PROMIS Smoking Assessment

    Smoking history and habits may be assessed using the PROMIS smoking assessment questionnaires. The questionnaire asks patients about their smoking habits, quit attempts, health expectations, and coping expectations.

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  18. PROMIS Cognitive Function- Short Form

    Cognitive function may be measured by the 8-item PROMIS questionnaire. The questionnaire assesses patient-perceived cognitive deficits including mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions.

    Min = 8; Max = 40; higher score = better cognitive function

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  19. PG-SGA Nutrition Assessment- Short Form

    The Patient-Generated Subjective Global Assessment (PG-SGA) is a patient-reported instrument for assessment of nutrition status in patients with cancer. The PG-SGA short form is completed by patients and screens for nutritional risk and deficit.

    Min = 0, Max = 36; higher score = worse nutrition status

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  20. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials. The PRO-CTCAE item library contains 124 items representing 78 symptomatic toxicities. Specific items can be selected to create an individualized form specific to a disease or treatment group.

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  21. Healthcare utilization

    To assess the impact of NAT and esophagectomy on healthcare utilization, participants may complete a validated healthcare utilization form.

    Measured: Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

  22. Pre-Treatment Resources Assessment

    This assessment may collect information on participants' knowledge of available supportive care resources prior to treatment and information they receive from their healthcare providers.

    Measured: Baseline

  23. Brief Pain Inventory (BPI)

    The BPI is a 9-item, self-assessment questionnaire that has been largely validated. The BPI measures both the intensity of pain (sensory dimension) and interference of pain in the participant's life (reactive dimension). It also asks the participant about pain relief, pain quality, and participant perception of the cause of pain.

    Measured: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2025
  2. Study start16 Jul 2025
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06872515
Sponsor's protocol ID
STUDY24120028
Status last verified
May 2026
First submitted
3 Mar 2025
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Nutrition in people with Esophageal Cancer and Esophageal Carcinoma, run by University of Pittsburgh 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 7 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: looking for participants now, as of the sponsor's last update on 26 May 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cara Battistella, MA (412-353-9102, battistellac@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of Intervention (time frame: From enrollment through surgical admission, up to 8 weeks). The study lists 3 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 26 May 2026.

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