Online Exercise Program During Perioperative Treatment in Adults With Gastric Cancer (On4Cancer): Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Aerobic capacity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Aerobic capacity
时间窗: Change from baseline to 1 week before surgery
Incremental Shuttle Walk Test (ISWT)
次要结局
- 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)
研究者
Lia Bahut
Principal Investigator
University of Maia