Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT06254300
NCT06254300RecruitingNot Applicable

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

University of Maia2 sites in 1 country40 target enrollmentStarted: March 23, 2022Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
Aerobic capacity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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-
  • •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.

Outcomes

Primary Outcomes

Aerobic capacity

Time Frame: Change from baseline to 1 week before surgery

Incremental Shuttle Walk Test (ISWT)

Secondary Outcomes

  • Number of hospitalizations(Within 30 days after surgery)
  • Adverse events(During the treatment (neoadjuvant chemotherapy))
  • Length of hospital stay(Within 30 days after surgery)
  • Muscle strength(Change from 30 days post-surgery to 15 days after the conclusion of curative treatment)
  • Health-related quality of life(Change from 30 days post-surgery to 15 days after the conclusion of curative treatment)
  • Calf circumference(Change from 30 days post-surgery to 15 days after the conclusion of curative treatment)
  • Postoperative morbidity outcomes(Within 30 days after surgery)
  • Aerobic capacity(Change from 30 days post-surgery to 15 days after the conclusion of curative treatment)
  • Gastric cancer specific health-related quality of life(Change from 30 days post-surgery to 15 days after the conclusion of curative treatment)
  • Body composition(Change from 30 days post-surgery to 15 days after the conclusion of curative treatment)
  • Physical activity(Change from 30 days post-surgery to 15 days after the conclusion of curative treatment)
  • Treatment compliance(Through chemotherapy completion)

Investigators

Sponsor
University of Maia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lia Bahut

Principal Investigator

University of Maia

Study Sites (2)

Loading locations...

Similar Trials

Completed
Phase 2
Perioperative mFOLFOX-6 in Locally Advanced Gastric CancerAdvanced Gastric Cancer
NCT02142322Seoul National University Hospital52
Completed
Phase 2
A Study of Perioperative Chemotherapy Plus Panitumumab in Patients With Colorectal Cancer Liver MetastasesLiver MetastasesColorectal Cancer
NCT01260415University Health Network, Toronto11
Completed
Phase 3
Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the EsophagusEsophageal Adenocarcinoma (UICC TNM7)Adenocarcinoma of the Esophagogastric JunctionC15Malignant neoplasm of oesophagus
DRKS00008008niversity Hospital Schleswig-Holstein438
Active, not recruiting
Phase 1
Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the Esophagus - ESOPECHistologically proven adenocarcinoma of the esophagus according to the Union internationale contre le cancer (UICC) TNM7 definition. Both tumors of the esophagus and tumors of which the epicentre is within 5 cm of the esophagogastric junction and also extend into the esophagus can be included into the trial in case of adenocarcinomatous histology.MedDRA version: 21.1Level: LLTClassification code 10026180Term: Malignant neoplasm of oesophagusSystem Organ Class: 100000004864
EUCTR2015-001683-20-DEniversitätsklinikum Schleswig-Holstein, Campus Lübeck438
Active, not recruiting
Not Applicable
Perioperative chemotherapy with FOLFOX plus Cetuximab versus adjuvant FOLFOX plus Cetuximab for patients with resectable liver metastases of colorectal carcinoma - Panter-studyresectable liver metastases of colorectal carcinoma with proven K-RAS wildtype
EUCTR2008-005312-41-ATRWTH Aachen University430