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

NCT05686213 | Unknown Phase 2 DMC

• 1 other identifier: NL81016.091.22
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Oncology

Outcome Measures

Primary Outcomes (4)

• Participation rate

  Participation will be assessed by calculating a rate between eligible patients and participating patients. An accrual rate lower than 20% will be defined as not feasible

  5 weeks (During intervention period)

• Exercise intervention attendance

  Attendance will be assessed dividing the number of attended sessions by the number of prescribed sessions. The information will be collected using questionnaires and exercise-logs registered by the physical therapists (AE+RT arm) and researcher (ExPR arm). These logs will be collected by the researcher.

  5 weeks (During intervention period)

• Intervention fidelity in terms of compliance

  Exercise intervention fidelity will be explored for both patient groups. Compliance will be evaluated by the session attendance.

  5 weeks (During intervention period)

• Exercise relative dose intensity (ExRDI)

  ExRDI will be determined as the ratio of total completed to total planned cumulative exercises dose, expressed as a percentage.

  5 weeks (During intervention period)

Secondary Outcomes (13)

• Body composition

  12-18 weeks (Baseline, post-intervention, pre-surgery)

• Estimated aerobic fitness

  12-18 weeks (Baseline, post-intervention, pre-surgery)

• Muscle strength

  12-18 weeks (Baseline, post-intervention, pre-surgery)

• Physical activity

  12-18 weeks (Baseline, post-intervention, pre-surgery)

• Health-related quality of life

  12-18 weeks (Baseline, post-intervention, pre-surgery)

Study Arms (3)

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

EXPERIMENTAL

Physical exercise during neaodjuvant chemoradiation

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

Aerobic exercise prior to daily radiotherapy sessions (ExPR)

EXPERIMENTAL

Physical exercise during neaodjuvant chemoradiation

Behavioral: Aerobic exercise prior to daily radiotherapy sessions (ExPR)

Usual care control (UC)

NO INTERVENTION

The control group will receive usual care and will be requested to maintain their usual daily physical activities.

Interventions

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

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.

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

Aerobic exercise prior to daily radiotherapy sessions (ExPR) BEHAVIORAL

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.

Aerobic exercise prior to daily radiotherapy sessions (ExPR)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with rectal or esophageal cancer
• Patients with rectal or esophageal cancer need to be scheduled for treatment with neoadjuvant chemoradiation therapy
• Oral capecitabine combined with concurrent radiotherapy (50 Gy in 25 fractions) for rectal cancer
• CROSS regimen (carboplatin, paclitaxel with concurrent 41.4 Gy in 23 fractions radiation) for esophageal cancer
• Aged \> 18 years
• Provided written informed-consent

You may not qualify if:

• Unable to perform basic activities of daily living such as walking or biking
• Presence of other disabling co-morbidity that might hamper or endanger physical exercise e.g. heart failure, chronic obstructive pulmonary disease, orthopaedic conditions and neurological disorders
• Presence of cognitive disorders or severe emotional instability (e.g., Schizophrenia, Alzheimer, alcohol addiction)
• Immunodeficiency (primary or secondary)
• Insufficient mastery of the Dutch language
• Participation in another exercise and/or dietary intervention study at the same time.
• Already participating in structured vigorous aerobic and/or resistance exercise ≥ 2 times per week comparable to our intervention and planning to continue this throughout the period of neoadjuvant chemoradiation.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud Institute for Health Science

Nijmegen, Gelderland, Netherlands

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: January 17, 2023
• Study Start: September 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2022-11

Locations

NL (1)