A study to assess the efficacy of Tablet Zinc on chemoradiotherapy induced oral mucositis in locally advanced head neck cancers

A randomized controlled trial to assess the efficacy of oral zinc sulphate on concurrent chemoradiotherapy induced oral mucositis in locally advanced head neck cancers - ZIROM trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/032106

Enrollment

Registered

2021-03-18

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: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Oral tablet Zinc 50 mg along with concurrent chemoradiotherapy: 60 cases of locally advanced carcinoma oropharynx, larynx and hypopharynx will be randomly allocated to use either oral t

Eligibility

Inclusion criteria

Inclusion criteria: 1. Suitable for definitive concurrent chemo-radiotherapy.2. Diagnosed cases of locally advanced carcinoma oropharynx, larynx and hypopharynx. 3. Biopsy proven Squamous cell carcinoma histology.

Exclusion criteria

Exclusion criteria: a)Recurrent disease b)Histology other than squamous cell carcinoma. c)Previous history of radiotherapy to head neck region

Design outcomes

Primary

Measure	Time frame
Primary Objectives: To compare incidence and severity of oral mucositis between study group (oral zinc) and control group (Placebo) Timepoint: During radiotherapy and at completion of radiotherapy	—

Secondary

Measure	Time frame
To compare the compliance of the chemoradiotherapy treatment between the study group and control group To compare incidence and severity of dysphagia between both the groups Timepoint: During radiotherapy and at completion of radiotherapy	—

Countries

India

Contacts

Public ContactDr Tej Prakash Soni

Bhagwan Mahaveer Cancer Hospital and Research Centre

drtejprakashsoni@yahoo.co.in91-141-2717777

Outcome results

None listed

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