Clinical trial NCT06254300: Online Exercise Program During Perioperative Treatment in Adults With Gastric Cancer
Official title: Online Exercise Program During Perioperative Treatment in Adults With Gastric Cancer (On4Cancer): Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Keywords: Physical Exercise
Gastric Cancer
Prehabilitation
Perioperative Cancer Treatment
Lead sponsor: University of Maia
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Aerobic capacity
timeFrame: Change from baseline to 1 week before surgery
Secondary outcomes:
measure: Aerobic capacity
timeFrame: Change from 1 week before surgery to 30 days post-surgery
measure: Aerobic capacity
timeFrame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
measure: Muscle strength
timeFrame: Change from baseline to 1 week before surgery
measure: Muscle strength
timeFrame: Change from 1 week before surgery to 30 days post-surgery
measure: Muscle strength
timeFrame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
measure: Body composition
timeFrame: Change from baseline to 1 week before surgery
measure: Body composition
timeFrame: Change from 1 week before surgery to 30 days post-surgery
measure: Body composition
timeFrame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
measure: Health-related quality of life
timeFrame: Change from baseline to 1 week before surgery
measure: Health-related quality of life
timeFrame: Change from 1 week before surgery to 30 days post-surgery
measure: Health-related quality of life
timeFrame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
measure: Gastric cancer specific health-related quality of life
timeFrame: Change from baseline to 1 week before surgery
measure: Gastric cancer specific health-related quality of life
timeFrame: Change from1 week before surgery to 30 days post-surgery
measure: Gastric cancer specific health-related quality of life
timeFrame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
measure: Physical activity
timeFrame: Change from baseline to 1 week before surgery
measure: Physical activity
timeFrame: Change from 1 week before surgery to 30 days post-surgery
measure: Physical activity
timeFrame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
measure: Calf circumference
timeFrame: Change from baseline to 1 week before surgery
measure: Calf circumference
timeFrame: Change from 1 week before surgery to 30 days post-surgery
measure: Calf circumference
timeFrame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
measure: Postoperative morbidity outcomes
timeFrame: Within 30 days after surgery
measure: Treatment compliance
timeFrame: Through chemotherapy completion
measure: Adverse events
timeFrame: During the treatment (neoadjuvant chemotherapy)
measure: Number of hospitalizations
timeFrame: Within 30 days after surgery
measure: Length of hospital stay
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho
Study officials:
References: