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| Name | Class |
|---|---|
| Istanbul University | OTHER |
| Umraniye Education and Research Hospital | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginger-Mint Chewing Gum | Other | Participants chew one piece of ginger-mint flavored, plant-based chewing gum for 15 minutes in the post-anesthesia care unit (PACU). |
|
| Cinnamon Chewing Gum | Other | Participants chew one piece of cinnamon-flavored, plant-based chewing gum for 15 minutes in the post-anesthesia care unit (PACU). |
|
| Standard Postoperative Care | No Intervention | Standard postoperative care, including routine antiemetic prophylaxis, is administered according to the institutional ERAS protocol and is not considered a study intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginger-Mint Chewing Gum | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 0 to 120 minutes postoperatively (measured at baseline, 15, 30, 45, 60, 75, 90, 105, and 120 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Vomiting or Retching | Presence or absence of vomiting or retching episodes recorded every 15 minutes (T1-T8). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CANSU MERT, MSc. | Contact | +905365954172 | cansu.mert@fbu.edu.tr | |
| Emre KUĞU, MSc. | Contact | emre.kugu@fbu.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences, Umraniye Training and Research Hospital | Istanbul | 34758 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28353600 | Background | Ge B, Zhao H, Lin R, Wang J, Chen Q, Liu L, Huang Q. Influence of gum-chewing on postoperative bowel activity after laparoscopic surgery for gastric cancer: A randomized controlled trial. Medicine (Baltimore). 2017 Mar;96(13):e6501. doi: 10.1097/MD.0000000000006501. | |
| 32467512 | Background | Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833. |
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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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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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Participants will be randomly assigned in a 1:1:1 ratio to one of three groups (ginger-mint gum, cinnamon gum, or control). Each group receives its assigned intervention in parallel, without crossover.
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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.
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| Cinnamon Chewing Gum | Other | 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. |
|
| 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. | 4 hours postoperatively |
| 39476041 | Background | Darvall JN, De Silva AP, von Ungern-Sternberg B, Story DA, Davidson AJ, Allen ML, Tran-Duy A, Schultz-Ferguson C, Ha V, Braat S, Leslie K; CHEWY Trial Group and the ANZCA Clinical Trials Network. Chewing Gum to Treat Postoperative Nausea and Vomiting in Female Patients: A Multicenter Randomized Trial. Anesthesiology. 2025 Mar 1;142(3):454-464. doi: 10.1097/ALN.0000000000005283. Epub 2024 Oct 30. |
| 40052026 | Background | Mehrabian S, Tirgari B, Beitollahi M, Forouzi MA, Khandani BK. Effect of Cinnamon Essential Oil on the Chemotherapy-Induced Nausea and Vomiting of Cancer Patients. Iran J Nurs Midwifery Res. 2025 Jan 15;30(1):81-86. doi: 10.4103/ijnmr.ijnmr_163_23. eCollection 2025 Jan-Feb. |
| 35713447 | Background | da Silva RLM, da Silva TTM, Pessoa RL, Sarmento ACA, Medeiros KS, Dantas DV, Dantas RAN. Use of ginger to control nausea and vomiting caused by chemotherapy in patients with cervical cancer undergoing treatment: An experiment. Medicine (Baltimore). 2022 Jun 17;101(24):e29403. doi: 10.1097/MD.0000000000029403. |
| 33197662 | Background | Efe Erturk N, Tasci S. The Effects of Peppermint Oil on Nausea, Vomiting and Retching in Cancer Patients Undergoing Chemotherapy: An Open Label Quasi-Randomized Controlled Pilot Study. Complement Ther Med. 2021 Jan;56:102587. doi: 10.1016/j.ctim.2020.102587. Epub 2020 Oct 9. |
| 39447066 | Background | Cetin N, Kose G, Gokbel A. Examining the Effect of Peppermint Oil on Postoperative Nausea After Cervical Surgery. J Neurosci Nurs. 2024 Dec 1;56(6):203-208. doi: 10.1097/JNN.0000000000000790. Epub 2024 Oct 24. |
| 26023350 | Background | Jaafarpour M, Hatefi M, Najafi F, Khajavikhan J, Khani A. The effect of cinnamon on menstrual bleeding and systemic symptoms with primary dysmenorrhea. Iran Red Crescent Med J. 2015 Apr 22;17(4):e27032. doi: 10.5812/ircmj.17(4)2015.27032. eCollection 2015 Apr. |
| 34093719 | Background | Zobeiri M, Parvizi F, Shahpiri Z, Heydarpour F, Pourfarzam M, Memarzadeh MR, Rahimi R, Farzaei MH. Evaluation of the Effectiveness of Cinnamon Oil Soft Capsule in Patients with Functional Dyspepsia: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Evid Based Complement Alternat Med. 2021 May 13;2021:6634115. doi: 10.1155/2021/6634115. eCollection 2021. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |