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Trial Title:
Online Exercise Program During Perioperative Treatment in Adults With Gastric Cancer
NCT ID:
NCT06254300
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Physical Exercise
Gastric Cancer
Prehabilitation
Perioperative Cancer Treatment
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise Training
Description:
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).
Arm group label:
Intervention Group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centro Hospitalar de Vila Nova de Gaia/Espinho
Address:
City:
Vila Nova De Gaia
Zip:
4434-502
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Sandra Custódio, MD
Email:
sandraisabelcustodio@gmail.com
Contact backup:
Last name:
Andreia Capela, MD
Email:
andreia.capela.marques@chvng.min-saude.pt
Start date:
March 23, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University of Maia
Agency class:
Other
Source:
University of Maia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06254300
