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Assessing the effect of nanomisel curcumin on prevention and treatment of nanomisel curcumin

Evaluation of the efficacy of nanomisel curcumin in preventing and treating oral candidiasis of patients undergoing head and neck radiation therapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180416039318N3
Enrollment
40
Registered
2018-06-02
Start date
2018-05-22
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

Oral Candidiasis. Candidal stomatitis/Oral thrush

Interventions

Intervention 1: Intervention group: nanocurcumin soft gel (containing 80 mg curcumin) are administrated orally once daily. Intervention 2: Control group: The control group: placebo tablets are adminis

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: the minimum age of 18 years, presence of head and neck cancer, radiation dose of 50-70 Gy, at least 50% of patient’s oral cavity in the field of radiation and patient satisfaction.

Exclusion criteria

Exclusion criteria: previous history of radiation therapy, patient dissatisfaction, history of allergy to turmeric, , in case of any oral lesions or complication resulting from radiation therapy other than candidiasis and mucositis, use of systemic or topical antifungal drugs for any reason, pregnancy or breastfeeding periods in women under treatment, presence of local and systemic conditions predisposing for candidiasis, such as the application of inhaled and topical steroids, presence of hyperkeratosis, use of immunosuppressive drugs, history of systemic antibiotic usage over the previous 2 weeks, the presence of CFU above 400/ml in the first culture or clinical evidence based on the presence of oral candidiasis.

Design outcomes

Primary

MeasureTime frame
Ccurrence of oral candidiasis. Timepoint: The first day of radiotherapy before radiation, every week until the end of the study. Method of measurement: Clinical examinations of oral lesion.;Candidate colony count in ml (colony forming unit = CFU). Timepoint: before the study, in the third week and the final week of radiotherapy. Method of measurement: Cultivation of oral lesions.

Secondary

MeasureTime frame
Type of oral Candidiasis. Timepoint: before the study, in the third week and the final week of radiotherapy. Method of measurement: germ tube test and cultivation of oral lesions.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSedigheh Modarres Mousavy

Mashhad University of Medical Sciences

ModarresMS921@mums.ac.ir+98 51 3882 9501

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026