JRCT ID: jRCT1030250292
Registered date:14/08/2025
Investigation of a sensory masking method to improve the palatability of rebamipide mouthwash in patients with pharyngeal cancer
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Pharyngeal Neoplasms |
| Date of first enrollment | 21/08/2025 |
| Target sample size | 25 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Randomized allocation of sensory masking flavor agents added to rebamipide mouthwash. |
Outcome(s)
| Primary Outcome | Overall taste evaluation (VAS) |
|---|---|
| Secondary Outcome | Bitterness (VAS),Sweetness (VAS),Sourness (VAS), Astringency (VAS),Overall palatability (5-point scale),Acceptability of the formulation (5-point scale) |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | < 80age old |
| Gender | Both |
| Include criteria | Patients with pharyngeal cancer who visited the Department of Otolaryngology, University of Yamanashi Hospital, between the date of approval by the head of the research institution and September 30, 2028, and who had been continuously prescribed rebamipide mouthwash for at least 21 days. Patients who provided written informed consent to participate in this study by signing the consent form themselves. |
| Exclude criteria | Pregnant or lactating women. Patients who already have oral mucositis that affects their ability to eat. Patients with a history of allergy to rebamipide or the sensory masking agents. Patients unable to communicate due to cognitive impairment or other reasons. Any other individuals deemed inappropriate for inclusion by the principal investigator or co-investigators. |
Related Information
| Primary Sponsor | Suzuki Takaaki |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Non-industry-sponsored scholarship donation from the Department of Pharmacy, University of Yamanashi Hospital and Non-industry-funded resources, such as the Special Research Promotion Fund for Faculty Members at the University of Shizuoka |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Akihiro Nagai |
| Address | 1110 Shimokawato, Chuo, Yamanashi 409-3898, Japan Yamanashi Japan 409-3898 |
| Telephone | +81-54-273-1111 |
| nagaia@yamanashi.ac.jp | |
| Affiliation | Department of Pharmacy, University of Yamanashi Hospital, Yamanashi, Japan |
| Scientific contact | |
| Name | Takaaki Suzuki |
| Address | 1110 Shimokawato, Chuo, Yamanashi 409-3898, Japan Yamanashi Japan 409-3898 |
| Telephone | +81-54-273-1111 |
| takaaki.s@yamanashi.ac.jp | |
| Affiliation | Department of Pharmacy, University of Yamanashi Hospital, Yamanashi, Japan |