Comparative Effectiveness of Ginger-Mint and Cinnamon-Flavored Gum in Preventing Nausea and Vomiting Following Pressurized Intraperitoneal Aerosol Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in Nausea Intensity (Numeric Rating Scale, 0-10)
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effectiveness of chewing gum with different natural flavors in reducing postoperative nausea and vomiting (PONV) following Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC). Adult patients undergoing PIPAC will be randomly assigned to one of three groups: (1) ginger-mint flavored gum, (2) cinnamon flavored gum, or (3) control group with standard postoperative care only. Participants in the intervention arms will chew one piece of gum for 15 minutes in the post-anesthesia care unit (PACU). Nausea intensity (Numeric Rating Scale, 0-10) and the presence of vomiting or retching will be assessed at baseline and every 15 minutes for 2 hours.
The study hypothesizes that ginger-mint and cinnamon flavored chewing gums, both plant-based and certified vegan, will be effective, non-pharmacological, and safe methods to reduce nausea and vomiting after PIPAC. This research may contribute to enhanced postoperative comfort and faster recovery by supporting the principles of Enhanced Recovery After Surgery (ERAS).
详细描述
Postoperative nausea and vomiting (PONV) are common and distressing complications in the early postoperative period and remain a significant concern despite routine prophylactic antiemetic use. This problem is particularly relevant in patients undergoing Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC), a minimally invasive but physiologically demanding oncologic procedure associated with increased postoperative discomfort.
Chewing gum has been proposed as a simple, non-pharmacological intervention that may reduce postoperative nausea by stimulating salivation and activating the cephalic-vagal pathway, thereby modulating gastrointestinal function. Previous studies in various surgical populations suggest that gum chewing may contribute to improved postoperative comfort; however, evidence comparing different natural flavors and their potential sensory or acceptability-related effects remains limited.
This study evaluates the comparative effectiveness of ginger-mint-flavored versus cinnamon-flavored chewing gum as an adjunct to standard postoperative care in reducing PONV following PIPAC. By comparing two natural flavors within a controlled clinical setting, the trial aims to explore whether flavor-specific sensory stimulation influences nausea perception and patient experience in the immediate postoperative period.
The findings of this study are expected to contribute to the development of simple, low-cost, and patient-friendly supportive care strategies aligned with Enhanced Recovery After Surgery (ERAS) principles for high-risk surgical populations.
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
盲法说明
Because the intervention involves chewing flavored gum, blinding of participants, investigators, and care providers is not feasible. The study will therefore be conducted as an open-label randomized controlled trial.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older undergoing Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC).
- •Able to communicate, understand study instructions, and provide written informed consent.
- •No known allergy or intolerance to ginger, mint, or cinnamon.
- •Able and willing to chew gum for 15 minutes.
- •Apfel risk score ≥3 for postoperative nausea and vomiting.
排除标准
- •Postoperative complications requiring intensive care or reoperation.
- •Need for rescue antiemetic medication within the first 2 postoperative hours.
- •History of psychiatric disorder, neurological disease, or cognitive impairment affecting participation.
- •Anatomical or functional limitation preventing chewing (e.g., full dentures, jaw restriction, oral surgery).
- •Known phenylketonuria or metabolic intolerance to chewing gum ingredients.
- •Active chemotherapy, radiotherapy, or immunosuppressive therapy affecting gastrointestinal function.
结局指标
主要结局
Change in Nausea Intensity (Numeric Rating Scale, 0-10)
时间窗: From 0 to 120 minutes postoperatively (measured at baseline, 15, 30, 45, 60, 75, 90, 105, and 120 minutes)
Nausea intensity will be assessed using the Numeric Rating Scale (NRS, 0-10) where 0 indicates no nausea and 10 indicates the worst possible nausea. The primary endpoint is the change in nausea scores over time (T0-T8). Mean scores and area under the curve (AUC) values will be compared between groups.
次要结局
- Incidence of Vomiting or Retching(0 to 120 minutes postoperatively)
- Requirement for Rescue Antiemetic(0 to 120 minutes postoperatively)
- Patient Acceptability of Chewing Gum(4 hours postoperatively)
研究者
Cansu Mert
Lecturer
Fenerbahce University