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).
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.
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).
Parallel
Ginger-Mint Chewing Gum
Other interventionParticipants chew one piece of ginger-mint flavored, plant-based chewing gum (Simply Gum Inc., Brooklyn, NY, USA) for 15 minutes under supervision in the post-anesthesia care unit (PACU) immediately after regaining full consciousness and airway control.
Cinnamon Chewing Gum
Other interventionParticipants chew one piece of cinnamon-flavored, plant-based chewing gum (Simply Gum Inc., Brooklyn, NY, USA) for 15 minutes under supervision in the PACU immediately after regaining full consciousness and airway control.
Change in Nausea Intensity (Numeric Rating Scale, 0-10)
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.
Incidence of Vomiting or Retching
Presence or absence of vomiting or retching episodes recorded every 15 minutes (T1-T8).
Requirement for Rescue Antiemetic
Whether the participant required any rescue antiemetic medication during the 2-hour postoperative observation period (Yes/No).
Patient Acceptability of Chewing Gum
Participants' feedback on taste, comfort, and perceived benefit of the chewing gum, assessed using a brief structured questionnaire.
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Fenerbahce University
Lead sponsor
Istanbul University
Collaborator
Umraniye Education and Research Hospital
Collaborator
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