Chewing Gum Flavors to Reduce Postoperative Nausea and Vomiting After PIPAC

Fenerbahce University

Status: Not yet enrolling

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

Treatments: Other: Ginger-Mint Chewing Gum; Other: Cinnamon Chewing Gum

Study type: Interventional

Funder types: Other

Identifiers

NCT07315412

99.2025fbu

Details and patient eligibility

About

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).

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Ginger-Mint Chewing Gum

Other group

Description:

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

Treatment:

Other: Ginger-Mint Chewing Gum

Cinnamon Chewing Gum

Other group

Description:

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

Treatment:

Other: Cinnamon Chewing Gum

Standard Postoperative Care

No Intervention group

Description:

Standard postoperative care, including routine antiemetic prophylaxis, is administered according to the institutional ERAS protocol and is not considered a study intervention.