Chewing Gum Flavors to Reduce Postoperative Nausea and Vomiting After PIPAC
NCT ID: NCT07315412
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
75 participants
INTERVENTIONAL
2025-12-10
2027-05-30
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Ginger-Mint Chewing Gum
Participants chew one piece of ginger-mint flavored, plant-based chewing gum for 15 minutes in the post-anesthesia care unit (PACU).
Ginger-Mint Chewing Gum
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.
Cinnamon Chewing Gum
Participants chew one piece of cinnamon-flavored, plant-based chewing gum for 15 minutes in the post-anesthesia care unit (PACU).
Cinnamon Chewing Gum
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.
Standard Postoperative Care
Standard postoperative care, including routine antiemetic prophylaxis, is administered according to the institutional ERAS protocol and is not considered a study intervention.
No interventions assigned to this group
Interventions
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Ginger-Mint Chewing Gum
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.
Cinnamon Chewing Gum
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Fenerbahce University
OTHER
Istanbul University
OTHER
Umraniye Education and Research Hospital
OTHER_GOV
Responsible Party
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Cansu Mert
Lecturer
Locations
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University of Health Sciences, Umraniye Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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99.2025fbu
Identifier Type: -
Identifier Source: org_study_id
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