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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The intervention group will participate in a supervised online exercise prehabilitation program that will extend throughout the chemotherapy until one week before the scheduled surgery. The exercise program will consist of three sessions per week, each lasting 60 minutes. The design of the prehabilitation program is based on exercise prescription recommendations for cancer survivors and will be tailored to each patient's initial functional capacity. The exercise sessions will be conducted at home through an online platform, enabling real-time interaction among groups of patients. |
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| Control Group | No Intervention | Participants from the control group will be offered optimal medical care, which includes general advice about healthy lifestyle including regular physical activity participation according to the current guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Training | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Aerobic capacity | Incremental Shuttle Walk Test (ISWT) | Change from baseline to 1 week before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Aerobic capacity | Incremental Shuttle Walk Test (ISWT) | Change from 1 week before surgery to 30 days post-surgery |
| Aerobic capacity | Incremental Shuttle Walk Test (ISWT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lia F Bahut, MSc | Contact | +351 22 986 6000 | lia.bahut@gmail.com | |
| Alberto Alves, PhD | Contact | +351 22 986 6000 | ajalves@ismai.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar de Vila Nova de Gaia/Espinho | Recruiting | Vila Nova de Gaia | 4434-502 | Portugal |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Change from 30 days post-surgery to 15 days after the conclusion of curative treatment |
| Muscle strength | Digital hand dynamometer | Change from baseline to 1 week before surgery |
| Muscle strength | Digital hand dynamometer | Change from 1 week before surgery to 30 days post-surgery |
| Muscle strength | Digital hand dynamometer | Change from 30 days post-surgery to 15 days after the conclusion of curative treatment |
| Body composition | Bioelectrical impedance | Change from baseline to 1 week before surgery |
| Body composition | Bioelectrical impedance | Change from 1 week before surgery to 30 days post-surgery |
| Body composition | Bioelectrical impedance | 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. | 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. | 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. | 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. | 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. | 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. | Change from 30 days post-surgery to 15 days after the conclusion of curative treatment |
| Physical activity | Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA) | Change from baseline to 1 week before surgery |
| Physical activity | Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA) | Change from 1 week before surgery to 30 days post-surgery |
| Physical activity | Accelerometer (wGT3X, ActiGraph LLC, Pensacola, FL, USA) | Change from 30 days post-surgery to 15 days after the conclusion of curative treatment |
| Calf circumference | Change from baseline to 1 week before surgery |
| Calf circumference | Change from 1 week before surgery to 30 days post-surgery |
| Calf circumference | Change from 30 days post-surgery to 15 days after the conclusion of curative treatment |
| Postoperative morbidity outcomes | Clavien-Dindo classification | Within 30 days after surgery |
| Treatment compliance | Relative dose intensity, calculated as the ratio of the delivered dose intensity to the standard dose intensity | Through chemotherapy completion |
| Adverse events | Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | During the treatment (neoadjuvant chemotherapy) |
| Number of hospitalizations | Within 30 days after surgery |
| Length of hospital stay | Within 30 days after surgery |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D001519 | Behavior |