Gastric Cancer
Conditions
Keywords
Physical Exercise, Gastric Cancer, Prehabilitation, Perioperative Cancer Treatment
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.
Interventions
BEHAVIORALExercise 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).
Sponsors
University of Maia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 0-1. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aerobic capacity | Change from baseline to 1 week before surgery | Incremental Shuttle Walk Test (ISWT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aerobic capacity | Change from 1 week before surgery to 30 days post-surgery | Incremental Shuttle Walk Test (ISWT) |
| Muscle strength | Change from baseline to 1 week before surgery | Digital hand dynamometer |
| Body composition | Change from baseline to 1 week before surgery | Bioelectrical impedance |
| Health-related quality of life | Change from baseline to 1 week before surgery | 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. |
| Gastric cancer specific health-related quality of life | Change from baseline to 1 week before surgery | 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. |
| Physical activity | Change from baseline to 1 week before surgery | Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA) |
| Calf circumference | Change from baseline to 1 week before surgery | — |
| Postoperative morbidity outcomes | Within 30 days after surgery | Clavien-Dindo classification |
| Treatment compliance | Through chemotherapy completion | Relative dose intensity, calculated as the ratio of the delivered dose intensity to the standard dose intensity |
| Adverse events | During the treatment (neoadjuvant chemotherapy) | Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) |
| Number of hospitalizations | Within 30 days after surgery | — |
| Length of hospital stay | Within 30 days after surgery | — |
Countries
Portugal
Contacts
Primary ContactLia F Bahut, MSc
Backup ContactAlberto Alves, PhD
Outcome results
None listed