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

University of Maia

Status: Enrolling

Conditions: Gastric Cancer

Treatments: Behavioral: Exercise Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06254300

On4Cancer

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Training

Control Group

No Intervention group

Description:

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.