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Postoperative Nausea and Vomiting (PONV)NCT07315412

Chewing Gum Flavors to Reduce Postoperative Nausea and Vomiting After PIPAC

A study testing Ginger-Mint Chewing Gum and Cinnamon Chewing Gum in people with Postoperative Nausea and Vomiting (PONV) and Peritoneal Metastases From Colorectal Cancer, run by Fenerbahce University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Ginger-Mint Chewing Gum and Cinnamon Chewing Gum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Dec 2025to 30 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

CANSU MERT, MSc. contact

+905365954172

cansu.mert@fbu.edu.tr

Emre KUĞU, MSc. contact

emre.kugu@fbu.edu.tr

Turkey (Türkiye)1 site
  • University of Health Sciences, Umraniye Training and Research Hospital

    Istanbul, 34758

    CANSU MERT, 05365954172, cansu.mert@fbu.edu.tr

    Özgül DÜZGÜN, Assist. Prof., ozgulduzgun@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Comparative Effectiveness of Ginger-Mint and Cinnamon-Flavored Gum in Preventing Nausea and Vomiting Following Pressurized Intraperitoneal Aerosol Chemotherapy

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).

Read the detailed description

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.

Being tested
Ginger-Mint Chewing Gum, Cinnamon Chewing Gum
Keywords
Chewing gum, ginger, cinnamon, postoperative neusea, vomiting, eras, supportive care
Medical subject headings
Postoperative Nausea and Vomiting, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ginger-Mint Chewing GumOther

    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 GumOther

    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.

Study groups in NCT07315412
Study groupRoleWhat they receive
Ginger-Mint Chewing GumOtherParticipants chew one piece of ginger-mint flavored, plant-based chewing gum for 15 minutes in the post-anesthesia care unit (PACU).
Receives: Other: Ginger-Mint Chewing Gum
Cinnamon Chewing GumOtherParticipants chew one piece of cinnamon-flavored, plant-based chewing gum for 15 minutes in the post-anesthesia care unit (PACU).
Receives: Other: Cinnamon Chewing Gum
Standard Postoperative CareNo interventionStandard postoperative care, including routine antiemetic prophylaxis, is administered according to the institutional ERAS protocol and is not considered a study intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From 0 to 120 minutes postoperatively (measured at baseline, 15, 30, 45, 60, 75, 90, 105, and 120 minutes)

Secondary outcomes (3)
  1. Incidence of Vomiting or Retching

    Presence or absence of vomiting or retching episodes recorded every 15 minutes (T1-T8).

    Measured: 0 to 120 minutes postoperatively

  2. Requirement for Rescue Antiemetic

    Whether the participant required any rescue antiemetic medication during the 2-hour postoperative observation period (Yes/No).

    Measured: 0 to 120 minutes postoperatively

  3. Patient Acceptability of Chewing Gum

    Participants' feedback on taste, comfort, and perceived benefit of the chewing gum, assessed using a brief structured questionnaire.

    Measured: 4 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2026
  2. Study start10 Dec 2025 (estimated)
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07315412
Sponsor's protocol ID
99.2025fbu
Status last verified
Dec 2025
First submitted
4 Dec 2025
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 28353600
  • 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.

    PubMed 32467512
  • 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.

    PubMed 39476041
  • 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.

    PubMed 40052026
  • 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.

    PubMed 35713447
  • 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.

    PubMed 33197662
  • 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.

    PubMed 39447066
  • 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.

    PubMed 26023350
  • 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.

    PubMed 34093719

Questions about this trial

What is this clinical trial studying?

A study testing Ginger-Mint Chewing Gum and Cinnamon Chewing Gum in people with Postoperative Nausea and Vomiting (PONV) and Peritoneal Metastases From Colorectal Cancer, run by Fenerbahce University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact CANSU MERT, MSc. (+905365954172, cansu.mert@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Nausea Intensity (Numeric Rating Scale, 0-10) (time frame: From 0 to 120 minutes postoperatively (measured at baseline, 15, 30, 45, 60, 75, 90, 105, and 120 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07315412, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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