An interventional study of Ginger-Mint Chewing Gum and Cinnamon Chewing Gum in Postoperative Nausea and Vomiting (PONV), Peritoneal Metastases From Colorectal Cancer and Intraperitoneal Chemotherapy, sponsored by Fenerbahce University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Fenerbahce University · Not applicable, Interventional, and Supportive care
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).
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.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
This study's planned enrollment of 75 is below the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Fenerbahce University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants chew one piece of ginger-mint flavored, plant-based chewing gum for 15 minutes in the post-anesthesia care unit (PACU).
Other: Ginger-Mint Chewing Gum
Participants chew one piece of cinnamon-flavored, plant-based chewing gum for 15 minutes in the post-anesthesia care unit (PACU).
Other: Cinnamon Chewing Gum
Standard postoperative care, including routine antiemetic prophylaxis, is administered according to the institutional ERAS protocol and is not considered a study intervention.
Participants 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.
Participants 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.
Time frame: From 0 to 120 minutes postoperatively (measured at baseline, 15, 30, 45, 60, 75, 90, 105, and 120 minutes)
Incidence of Vomiting or Retching
Presence or absence of vomiting or retching episodes recorded every 15 minutes (T1-T8).
Time frame: 0 to 120 minutes postoperatively
Requirement for Rescue Antiemetic
Whether the participant required any rescue antiemetic medication during the 2-hour postoperative observation period (Yes/No).
Time frame: 0 to 120 minutes postoperatively
Patient Acceptability of Chewing Gum
Participants' feedback on taste, comfort, and perceived benefit of the chewing gum, assessed using a brief structured questionnaire.
Time frame: 4 hours postoperatively
Plan to share: No — Individual participant data will not be shared because this is a single-center, small-scale interventional study conducted with postoperative patients. The dataset includes sensitive clinical information and cannot be anonymized sufficiently to ensure participant confidentiality. Summary-level results will be made available in publications and upon reasonable request.
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Postoperative Nausea and Vomiting →
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