NCT06430346

Brief Summary

The purpose of the study is to examine the feasibility and acceptability of exercise "prehabilitation" for patients preparing for esophageal cancer resection (removal).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
May 2024May 2027

First Submitted

Initial submission to the registry

May 21, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

December 4, 2025

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

May 21, 2024

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Retention

    The number of participants who complete T0 and T1 measures.

    Up to 11 weeks

Secondary Outcomes (2)

  • Exploratory outcomes and changes

    Up to 17 weeks

  • Clinical and treatment outcomes

    Up to 17 weeks

Study Arms (1)

Exercise prehabilitation

EXPERIMENTAL

In this trial participants will participate in an exercise program for 5 to 17 weeks, varying with treatment plans. Participants will receive resistance training equipment and participate in resistance training sessions twice per week (approximately 30-45 minutes per session). A Fitbit device will be provided to monitor step counts.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Physical activity and resistance training

Exercise prehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy-proven locoregional esophageal cancer (LEC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Treatment plan including neoadjuvant chemoradiation therapy and surgical resection
  • Ability to read and speak English

You may not qualify if:

  • Regular engagement in resistance training (2x/week targeting all major muscle groups)
  • Screen failure for exercise safety based on PAR-Q
  • Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
  • Recent fracture or acute musculoskeletal injury that precludes ability to participate in resistance training safely
  • Numeric pain rating scale of 7 or more out of 10
  • Myopathic or rheumatologic disease that impacts physical function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nathan Parker, PhD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan Parker, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

May 28, 2024

Study Start

May 21, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

December 4, 2025

Record last verified: 2025-12

Locations