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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho
RECRUITING
Vila Nova De Gaia
Contact Information
Primary
Lia F Bahut, MSc
lia.bahut@gmail.com
+351 22 986 6000
Backup
Alberto Alves, PhD
ajalves@ismai.pt
+351 22 986 6000
Time Frame
Start Date: 2022-03-23
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Maia

This content was sourced from clinicaltrials.gov

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