Chewing Gum Flavors to Reduce Postoperative Nausea and Vomiting After PIPAC

NCT07315412 | Not Yet Recruiting

• 1 other identifier: 99.2025fbu
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Keywords

Chewing gum; ginger; cinnamon; postoperative neusea; vomiting; eras; supportive care

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Incidence of Vomiting or Retching

  0 to 120 minutes postoperatively

• Requirement for Rescue Antiemetic

  0 to 120 minutes postoperatively

• Patient Acceptability of Chewing Gum

  4 hours postoperatively

Study Arms (3)

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).

Other: Ginger-Mint Chewing Gum

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).

Other: Cinnamon Chewing Gum

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.

Interventions

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.

Ginger-Mint Chewing Gum

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.

Cinnamon Chewing Gum

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fenerbahce University: lead
• Istanbul University: collaborator
• Umraniye Education and Research Hospital: collaborator

Study Sites (1)

University of Health Sciences, Umraniye Training and Research Hospital

Istanbul, 34758, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 28353600 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.

  PMID: 32467512 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.

  PMID: 39476041 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.

  PMID: 40052026 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.

  PMID: 35713447 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.

  PMID: 33197662 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.

  PMID: 39447066 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.

  PMID: 26023350 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.

  PMID: 34093719 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms

Central Study Contacts

CANSU MERT, MSc.

CONTACT

+905365954172; cansu.mert@fbu.edu.tr

Emre KUĞU, MSc.

CONTACT

emre.kugu@fbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 2, 2026
• Study Start: December 10, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)