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A randomized, prospective trial of the addition of curcumin mouthwash for preventing and relieving oral mucositis in locally advanced head and neck squamous cell carcinoma (HNSCC) patients who undergo definitive concurrent chemo-radiotherapy

A randomized, prospective trial of the addition of curcumin mouthwash for preventing and relieving oral mucositis in locally advanced head and neck squamous cell carcinoma (HNSCC) patients who undergo definitive concurrent chemo-radiotherapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200820002
Enrollment
30
Registered
2020-08-20
Start date
2020-08-17
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

locally advanced head and neck squamous cell carcinoma (HNSCC) patients who undergo definitive concurrent chemo&#45

Interventions

Curcumin mouthwash was scientifically prepared under the expertise of Department of Pharmaceutics&#44
College of Pharmacy. Curcumin solutions were suggested to be used 5 gram of standard curcumin powder (orangish yellow colored powder) available from the Pharmacy Division&#44
Songklanagarind Hospital&#44
soaked in 100 milliliters of oil (coconut oil) continuously for 24 hours&#44
then filter out the waste and bottling.,Normal saline sollution (0.9%NaCl)which is traditional mouthwash in hospital
Experimental Drug,Active Comparator Drug
Curcumin mouthwash,Normal saline solution

Sponsors

Human Research Ethic Committee (HREC),Faculty of Medicine, Prince of songkla university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years 2.ECOG 0-1 3.Histologically confirmed, squamous cell carcinoma of head and neck stage III, IVa, IVb (AJCC Cancer Staging, Eighth Edition) 4.Adequate organ function 5.Suitable candidates for concurrent chemo-radiation with cisplatin regimen every 3 weeks. Patients with recurrence of cancer in the oral cavity were eligible. 6.Provide informed consent prior to any study procedure 7.Minimum radiation dose of 50 Gy

Exclusion criteria

Exclusion criteria: 1.Neoadjuvant / induction chemotherapy 2.Participants exposed to previous radiotherapy in head and neck area 3.Known hypersensitivity to study drugs 4.Pregnancy or lactating woman 5.Inability to communicate and comply with all study requirements 6.Terminally ill 7.Using any prophylactic or therapeutic mouthwash 8.Unable to comply with curcumin mouthwash as judged by the patient himself or investigator and confirmed by screening check list 9.Patient who had oral surgery within the previous 6 weeks. 10.Patients with poor oral hygiene and xerostomia 11.Patients with comorbid conditions (poorly controlled diabetes mellitus, hypertension, schizophrenia, bipolar disorders, severe depression) 12.The participants who are in the other research projects cannot be recruited

Design outcomes

Primary

MeasureTime frame
efficacy of curcumin mouthwash for preventing oral mucositis in locally advanced head and neck squam 9 weeks WHO oral mucositis grading scale—

Secondary

MeasureTime frame
Difference of severity of oral mucositis defined by other scoring system 9 weeks Oral mucositis grading scale by Sonis et al.—

Countries

Thailand

Contacts

Public ContactJakkapan Rongmuang

Oncology division, Internal medicine departmen, Faculty of Medicine, Prince of songkla university

jakkapan.rongmuang@outlook.com0872795586

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026