University of Health Sciences, Umraniye Training and Research Hospital
Istanbul, 34758, Turkey (Türkiye)
Location contact
CANSU MERT
CONTACT
Özgül DÜZGÜN, Asisst. Prof.
PRINCIPAL_INVESTIGATOR
Özgül DÜZGÜN, Assist. Prof.
CONTACT
NCT Number: NCT07315412
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).
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Istanbul, 34758, Turkey (Türkiye)
CANSU MERT
CONTACT
Özgül DÜZGÜN, Asisst. Prof.
PRINCIPAL_INVESTIGATOR
Özgül DÜZGÜN, Assist. Prof.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 0 to 120 minutes postoperatively
Presence or absence of vomiting or retching episodes recorded every 15 minutes (T1-T8).
Time frame: 0 to 120 minutes postoperatively
Whether the participant required any rescue antiemetic medication during the 2-hour postoperative observation period (Yes/No).
Time frame: 4 hours postoperatively
Participants' feedback on taste, comfort, and perceived benefit of the chewing gum, assessed using a brief structured questionnaire.
Contact information is provided by the study sponsor or research team.
Fenerbahce University
Other
Comparative Effectiveness of Ginger-Mint and Cinnamon-Flavored Gum in Preventing Nausea and Vomiting Following Pressurized Intraperitoneal Aerosol Chemotherapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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