Chewing Gum Flavors to Reduce Postoperative Nausea and Vomiting After PIPAC

NCT ID: NCT07315412

Last Updated: 2026-01-02

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2027-05-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Postoperative Nausea and Vomiting (PONV) Peritoneal Metastases From Colorectal Cancer Intraperitoneal Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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.

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).

Group Type OTHER

Ginger-Mint Chewing Gum

Intervention Type 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.

Cinnamon Chewing Gum

Participants chew one piece of cinnamon-flavored, plant-based chewing gum for 15 minutes in the post-anesthesia care unit (PACU).

Group Type OTHER

Cinnamon Chewing Gum

Intervention Type 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.

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.

Group Type NO_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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
* Apfel risk score ≥3 for postoperative nausea and vomiting.

Exclusion Criteria

* 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).
* Known phenylketonuria or metabolic intolerance to chewing gum ingredients.
* Active chemotherapy, radiotherapy, or immunosuppressive therapy affecting gastrointestinal function.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fenerbahce University

OTHER

Sponsor Role lead

Istanbul University

OTHER

Sponsor Role collaborator

Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Responsible Party

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Cansu Mert

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Health Sciences, Umraniye Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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CANSU MERT, MSc.

Role: CONTACT

+905365954172

Emre KUĞU, MSc.

Role: CONTACT

Facility Contacts

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CANSU MERT

Role: primary

05365954172

Özgül DÜZGÜN, Assist. Prof.

Role: backup

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.

Reference Type BACKGROUND
PMID: 28353600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32467512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39476041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40052026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35713447 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33197662 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39447066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26023350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34093719 (View on PubMed)

Other Identifiers

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99.2025fbu

Identifier Type: -

Identifier Source: org_study_id

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