A clinical trial to study the efficacy and safety of zinc in prevention of oral mucositis in children receiving chemotherapy

Efficacy and Safety of Zinc in the Prevention of Oral Mucositis in Children with Cancer receiving intensified Chemotherapy: A Randomized Double-Blind Placebo-Controlled Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031600

Enrollment

110

Registered

2021-02-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL] Health Condition 2: C920- Acute myeloblastic leukemia Health Condition 3: C801- Malignant (primary) neoplasm, unspecified Health Condition 4: C409- Malignant neoplasm of unspecifiedbones and articular cartilage of limb Health Condition 5: C851- Unspecified B-cell lymphoma

Interventions

Intervention1: Oral Zinc: Oral Zinc gluconate solution is prepared from marketed formulation of oral Zinc powder in the dose of 20mg/5ml and administered in dose of 1mg/kg/day. Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of 3-18 years of age with cancer receiving intensified chemotherapy 2.Informed consent 3.No any oral lesion at the time of enrollment

Exclusion criteria

Exclusion criteria: 1.Patient receiving intensified chemotherapy over a period of more than five days 2.If child received systematic zinc within last 14 days for any indication for a period of more than 5 days. 3.Any contra-indications to the use of oral zinc: 3.1 Any documented allergic reaction/hypersensitivity to oral zinc 3.2 Any patient who is vomiting excessively due to any cause.

Design outcomes

Primary

Measure	Time frame
Reduction in incidence of oral mucositis after oral zinc administration as compared to placeboTimepoint: 2 weeks	—

Secondary

Measure	Time frame
Adverse effect of Oral ZincTimepoint: 2 weeks;Duration of oral mucositisTimepoint: 2 weeks;Incidence of Febrile NeutropeniaTimepoint: 2 weeks;Mortality due to any causeTimepoint: 2 weeks;Need of In-patient CareTimepoint: 2 weeks	—

Countries

India

Contacts

Public ContactDinesh Shah

All India Institute Of Medical Sciences, New Delhi

shahdinesh965@yahoo.com8595791618

Outcome results

None listed

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