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ExeNTrO: Exercise During Neoadjuvant Chemoradiation Treatment to Improve Rectal and Esophageal Cancer Outcome - Pilot Trial

NCT05686213 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-02-08

No results posted yet for this study

Summary

The goals of this study is to 1) evaluate feasibility and fidelity of a three-arm RCT containing a twice-weekly exercise intervention supervised by a first-line (oncology) physiotherapist and a 5-day weekly in-hospital exercise intervention versus usual care in patients with rectal cancer or esophageal cancer receiving NCRT, and 2) generate preliminary data on the variability in exercise responses on immune function, immune infiltration, and vascularisation of the tumour.

Participants will be randomized in one of three study arms: 1) AE + RE - group; combined moderate-to-high intensity aerobic exercise (AE) and resistance exercise (RE) twice a week supervised by a specially trained first-line physiotherapist, and a home-based moderate intensity aerobic exercise session once a week; 2) ExPR - group; in-hospital exercise intervention consisting of 30 min moderate intensity aerobic exercise within one hour prior to every radiotherapy session (five times a week); and 3) UC - group; a control group that receives usual care.

The main study parameters will be the feasibility in terms of trial participation rate and attendance, and intervention fidelity (e.g. extend of and reasons for adaptations to the exercise intervention). The secondary study parameters are the average effect sizes and measures of variability on immune function, infiltration and vascularisation. Measurements will take place at baseline, directly after finishing NCRT, and within a week before surgery.

Conditions

Interventions

BEHAVIORAL

combined aerobic exercise + resistance exercise intervention (AE + RE)

The AE + RE intervention group will be offered a supervised exercise program which includes both aerobic and resistance exercise. Exercise sessions will take place twice a week with a duration of 60 minutes. The training load will be tailored to a patient's individual fitness level throughout the intervention. Patient will be asked to be physically active on an additional day in the week on their own (for at least 30 minutes at moderate intensity) according to the ACSM guidelines for patients with cancer.

BEHAVIORAL

Aerobic exercise prior to daily radiotherapy sessions (ExPR)

Patients in the ExPR in-hospital exercise intervention group will be offered an aerobic exercise program at moderate intensity. The exercise sessions will take place 5 days a week (only weekdays), and will have a duration of 30 minutes including a warming-up (5 min) and cooling-down (5 min). Total exercise volume will be aimed at 150 min per week. The sessions will take place within an hour before the daily radiotherapy session.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-03-01
Completion
2024-03-01

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05686213 on ClinicalTrials.gov