Online Exercise Program During Perioperative Treatment in Adults With Gastric Cancer

Gastric Cancer Clinical Trial

— On4Cancer  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254300
• Other study ID #: On4Cancer
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: University of Maia
• Contact: Lia F Bahut, MSc
• Phone: +351 22 986 6000
• Email: lia.bahut[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Behavioral:
• Exercise Training
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).

Locations

Country	Name	City	State
Portugal	Centro Hospitalar de Vila Nova de Gaia/Espinho	Vila Nova De Gaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Maia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aerobic capacity	Incremental Shuttle Walk Test (ISWT)	Change from baseline to 1 week before surgery
Secondary	Aerobic capacity	Incremental Shuttle Walk Test (ISWT)	Change from 1 week before surgery to 30 days post-surgery
Secondary	Aerobic capacity	Incremental Shuttle Walk Test (ISWT)	Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Secondary	Muscle strength	Digital hand dynamometer	Change from baseline to 1 week before surgery
Secondary	Muscle strength	Digital hand dynamometer	Change from 1 week before surgery to 30 days post-surgery
Secondary	Muscle strength	Digital hand dynamometer	Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Secondary	Body composition	Bioelectrical impedance	Change from baseline to 1 week before surgery
Secondary	Body composition	Bioelectrical impedance	Change from 1 week before surgery to 30 days post-surgery
Secondary	Body composition	Bioelectrical impedance	Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Secondary	Health-related quality of life	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The final scores will range from 0 to 100, with higher scores on the functional scales representing a high level of functioning and higher scores on the symptom scales implying a stronger symptom burden.	Change from baseline to 1 week before surgery
Secondary	Health-related quality of life	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The final scores will range from 0 to 100, with higher scores on the functional scales representing a high level of functioning and higher scores on the symptom scales implying a stronger symptom burden.	Change from 1 week before surgery to 30 days post-surgery
Secondary	Health-related quality of life	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The final scores will range from 0 to 100, with higher scores on the functional scales representing a high level of functioning and higher scores on the symptom scales implying a stronger symptom burden.	Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Secondary	Gastric cancer specific health-related quality of life	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach (EORTC QLQ-STO22). The final scores will range from 0 to 100, with higher scores indicating worse symptomatic problems.	Change from baseline to 1 week before surgery
Secondary	Gastric cancer specific health-related quality of life	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach (EORTC QLQ-STO22). The final scores will range from 0 to 100, with higher scores indicating worse symptomatic problems.	Change from1 week before surgery to 30 days post-surgery
Secondary	Gastric cancer specific health-related quality of life	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach (EORTC QLQ-STO22). The final scores will range from 0 to 100, with higher scores indicating worse symptomatic problems.	Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Secondary	Physical activity	Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA)	Change from baseline to 1 week before surgery
Secondary	Physical activity	Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA)	Change from 1 week before surgery to 30 days post-surgery
Secondary	Physical activity	Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA)	Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Secondary	Calf circumference		Change from baseline to 1 week before surgery
Secondary	Calf circumference		Change from 1 week before surgery to 30 days post-surgery
Secondary	Calf circumference		Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Secondary	Postoperative morbidity outcomes	Clavien-Dindo classification	Within 30 days after surgery
Secondary	Treatment compliance	Relative dose intensity, calculated as the ratio of the delivered dose intensity to the standard dose intensity	Through chemotherapy completion
Secondary	Adverse events	Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	During the treatment (neoadjuvant chemotherapy)
Secondary	Number of hospitalizations		Within 30 days after surgery
Secondary	Length of hospital stay		Within 30 days after surgery