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

Phase 3

• Conditions: 4.curcumin; radiotherapy; 1.head and neck cancer; 3.mouthwash; locally advanced head and neck squamous cell carcinoma (HNSCC) patients who undergo definitive concurrent chemo- 2.definitive concurrent chemo&#45

• Registration Number: TCTR20200820002
• Lead Sponsor: Human Research Ethic Committee (HREC),Faculty of Medicine, Prince of songkla university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-20
• Study Completion: 2020-11-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy of curcumin mouthwash for preventing oral mucositis in locally advanced head and neck squam 9 weeks WHO oral mucositis grading scale

Secondary Outcome Measures

Name	Time	Method
Difference of severity of oral mucositis defined by other scoring system 9 weeks Oral mucositis grading scale by Sonis et al.