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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
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).
Centro Hospitalar de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Portugal
RECRUITINGAerobic capacity
Incremental Shuttle Walk Test (ISWT)
Time frame: Change from baseline to 1 week before surgery
Aerobic capacity
Incremental Shuttle Walk Test (ISWT)
Time frame: Change from 1 week before surgery to 30 days post-surgery
Aerobic capacity
Incremental Shuttle Walk Test (ISWT)
Time frame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Muscle strength
Digital hand dynamometer
Time frame: Change from baseline to 1 week before surgery
Muscle strength
Digital hand dynamometer
Time frame: Change from 1 week before surgery to 30 days post-surgery
Muscle strength
Digital hand dynamometer
Time frame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Body composition
Bioelectrical impedance
Time frame: Change from baseline to 1 week before surgery
Body composition
Bioelectrical impedance
Time frame: Change from 1 week before surgery to 30 days post-surgery
Body composition
Bioelectrical impedance
Time frame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
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.
Time frame: Change from baseline to 1 week before surgery
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.
Time frame: Change from 1 week before surgery to 30 days post-surgery
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.
Time frame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
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.
Time frame: Change from baseline to 1 week before surgery
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.
Time frame: Change from1 week before surgery to 30 days post-surgery
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.
Time frame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Physical activity
Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA)
Time frame: Change from baseline to 1 week before surgery
Physical activity
Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA)
Time frame: Change from 1 week before surgery to 30 days post-surgery
Physical activity
Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA)
Time frame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Calf circumference
Time frame: Change from baseline to 1 week before surgery
Calf circumference
Time frame: Change from 1 week before surgery to 30 days post-surgery
Calf circumference
Time frame: Change from 30 days post-surgery to 15 days after the conclusion of curative treatment
Postoperative morbidity outcomes
Clavien-Dindo classification
Time frame: Within 30 days after surgery
Treatment compliance
Relative dose intensity, calculated as the ratio of the delivered dose intensity to the standard dose intensity
Time frame: Through chemotherapy completion
Adverse events
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: During the treatment (neoadjuvant chemotherapy)
Number of hospitalizations
Time frame: Within 30 days after surgery
Length of hospital stay
Time frame: Within 30 days after surgery
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