Online Exercise Program During Perioperative Treatment in Adults With Gastric Cancer
On4Cancer
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable gastric-cancer
Started Mar 2022
Typical duration for not_applicable gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2022
CompletedFirst Submitted
Initial submission to the registry
January 23, 2024
CompletedFirst Posted
Study publicly available on registry
February 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 12, 2024
February 1, 2024
3.4 years
January 23, 2024
February 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Aerobic capacity
Incremental Shuttle Walk Test (ISWT)
Change from baseline to 1 week before surgery
Secondary Outcomes (25)
Aerobic capacity
Change from 1 week before surgery to 30 days post-surgery
Aerobic capacity
Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Muscle strength
Change from baseline to 1 week before surgery
Muscle strength
Change from 1 week before surgery to 30 days post-surgery
Muscle strength
Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
- +20 more secondary outcomes
Study Arms (2)
Intervention Group
EXPERIMENTALThe 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.
Control Group
NO INTERVENTIONParticipants 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Hospitalar de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, 4434-502, Portugal
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 23, 2024
First Posted
February 12, 2024
Study Start
March 23, 2022
Primary Completion
July 31, 2025
Study Completion
December 31, 2025
Last Updated
February 12, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share