Online Exercise Program During Perioperative Treatment in Adults With Gastric Cancer (On4Cancer)

Online Exercise Program During Perioperative Treatment in Adults With Gastric Cancer (On4Cancer): Randomized Controlled Trial

Perioperative chemotherapy with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT4) is the standard perioperative treatment for resectable and advanced gastric adenocarcinoma. Although the FLOT4 regimen have shown increases in the overall survival, response rate, and progression-free survival, it is also associated with substantial toxicities. Prehabilitation is an effective strategy to improve physical fitness in cancer patients and reverse functional limitations and inadequate levels of physical activity that are associated with worse postoperative outcomes and treatment response. Therefore, the main objective of this study is to evaluate the effects of an online, supervised exercise-based prehabilitation program on the cardiorespiratory fitness level, functional fitness and quality of life among adults with gastric cancer undergoing neoadjuvant chemotherapy.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Behavioral: Exercise Training

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lia F Bahut, MSc; Phone Number: +351 22 986 6000; Email: lia.bahut@gmail.com
• Study Contact Backup: Name: Alberto Alves, PhD; Phone Number: +351 22 986 6000; Email: ajalves@ismai.pt

Study Locations

• Portugal
  • Vila Nova De Gaia, Portugal, 4434-502
    • Recruiting
    • Centro Hospitalar de Vila Nova de Gaia/Espinho
    • Contact: Sandra Custódio, MD; Email: sandraisabelcustodio@gmail.com
    • Contact: Andreia Capela, MD; Email: andreia.capela.marques@chvng.min-saude.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years.
• Willingness to participate in the study.
• Referral for surgical treatment for gastric cancer.
• Diagnosis of gastric cancer for curative intent - stage II/III
• Referall to the perioperative FLOT4 chemotherapy regimen
• ECOG PS 0-1.
• Receptiveness and availability to use the proposed technology for exercise sessions

Exclusion Criteria:

• Inability to provide informed consent
• Inability to engage in physical training or perform the baseline walking test
• Presence of distant metastatic disease
• History of previous or concurrent malignancy
• Diagnosis of heart failure, ischemic heart disease, or sinus node valvular disease
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The intervention group will participate in a supervised online exercise prehabilitation program that will extend throughout the chemotherapy until one week before the scheduled surgery. The exercise program will consist of three sessions per week, each lasting 60 minutes. The design of the prehabilitation program is based on exercise prescription recommendations for cancer survivors and will be tailored to each patient's initial functional capacity. The exercise sessions will be conducted at home through an online platform, enabling real-time interaction among groups of patients.	Behavioral: Exercise Training; The exercise program will consist of three sessions per week, each lasting 60 minutes. The aerobic exercise will gradually increase the duration throughout the program to 40 minutes and exercise intensity from 30% to 59% of heart rate reserve. The resistance training will include bodyweight functional exercises and resistance exercises using elastic bands. The intensity of resistance exercise will progressively increase according to levels of progressive length and resistance of the elastic bands. The volume of resistance training will start with one set of 8 repetions. It will then gradually increase alongside the program to 2 sets of 12 repetitions. Participants will also be guided to assess their subjective effort using the Borg scale (RPE 12-15).
No Intervention: Control Group; Participants from the control group will be offered optimal medical care, which includes general advice about healthy lifestyle including regular physical activity participation according to the current guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic capacity	Incremental Shuttle Walk Test (ISWT)	Change from baseline to 1 week before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic capacity	Incremental Shuttle Walk Test (ISWT)	Change from 1 week before surgery to 30 days post-surgery
Aerobic capacity	Incremental Shuttle Walk Test (ISWT)	Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Muscle strength	Digital hand dynamometer	Change from baseline to 1 week before surgery
Muscle strength	Digital hand dynamometer	Change from 1 week before surgery to 30 days post-surgery
Muscle strength	Digital hand dynamometer	Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Body composition	Bioelectrical impedance	Change from baseline to 1 week before surgery
Body composition	Bioelectrical impedance	Change from 1 week before surgery to 30 days post-surgery
Body composition	Bioelectrical impedance	Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Health-related quality of life	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The final scores will range from 0 to 100, with higher scores on the functional scales representing a high level of functioning and higher scores on the symptom scales implying a stronger symptom burden.	Change from baseline to 1 week before surgery
Health-related quality of life	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The final scores will range from 0 to 100, with higher scores on the functional scales representing a high level of functioning and higher scores on the symptom scales implying a stronger symptom burden.	Change from 1 week before surgery to 30 days post-surgery
Health-related quality of life	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The final scores will range from 0 to 100, with higher scores on the functional scales representing a high level of functioning and higher scores on the symptom scales implying a stronger symptom burden.	Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Gastric cancer specific health-related quality of life	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach (EORTC QLQ-STO22). The final scores will range from 0 to 100, with higher scores indicating worse symptomatic problems.	Change from baseline to 1 week before surgery
Gastric cancer specific health-related quality of life	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach (EORTC QLQ-STO22). The final scores will range from 0 to 100, with higher scores indicating worse symptomatic problems.	Change from1 week before surgery to 30 days post-surgery
Gastric cancer specific health-related quality of life	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach (EORTC QLQ-STO22). The final scores will range from 0 to 100, with higher scores indicating worse symptomatic problems.	Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Physical activity	Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA)	Change from baseline to 1 week before surgery
Physical activity	Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA)	Change from 1 week before surgery to 30 days post-surgery
Physical activity	Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA)	Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Calf circumference		Change from baseline to 1 week before surgery
Calf circumference		Change from 1 week before surgery to 30 days post-surgery
Calf circumference		Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Postoperative morbidity outcomes	Clavien-Dindo classification	Within 30 days after surgery
Treatment compliance	Relative dose intensity, calculated as the ratio of the delivered dose intensity to the standard dose intensity	Through chemotherapy completion
Adverse events	Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	During the treatment (neoadjuvant chemotherapy)
Number of hospitalizations		Within 30 days after surgery
Length of hospital stay		Within 30 days after surgery

Collaborators and Investigators

• Sponsor: University of Maia

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Gastric Cancer; Prehabilitation; Physical Exercise; Perioperative Cancer Treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: On4Cancer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No