Intraperitoneal Chemotherapy, Peritoneal Metastases From Colorectal Cancer, Postoperative Nausea and Vomiting (PONV)
Conditions
Keywords
Chewing gum, ginger, cinnamon, postoperative neusea, vomiting, eras, supportive care
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).
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.
Interventions
OTHERGinger-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.
OTHERCinnamon 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.
Sponsors
Istanbul University
Umraniye Education and Research Hospital
Fenerbahce University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nausea Intensity (Numeric Rating Scale, 0-10) | From 0 to 120 minutes postoperatively (measured at baseline, 15, 30, 45, 60, 75, 90, 105, and 120 minutes) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Vomiting or Retching | 0 to 120 minutes postoperatively | Presence or absence of vomiting or retching episodes recorded every 15 minutes (T1-T8). |
| Requirement for Rescue Antiemetic | 0 to 120 minutes postoperatively | Whether the participant required any rescue antiemetic medication during the 2-hour postoperative observation period (Yes/No). |
| Patient Acceptability of Chewing Gum | 4 hours postoperatively | Participants' feedback on taste, comfort, and perceived benefit of the chewing gum, assessed using a brief structured questionnaire. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactCANSU MERT, MSc.
Backup ContactEmre KUĞU, MSc.
Outcome results
None listed