Zinc-L-Carnosine Prevents Dysphagia in Breast Cancer Patients Undergoing Adjuvant Radiotherapy

Cynthia Aristei

Status and phase: Completed; Phase 3

Conditions: Dysphagia; Breast Cancer Female; Adjuvant Radiotherapy

Treatments: Device: Hepilor

Study type: Interventional

Funder types: Other

Identifiers

NCT03997188

003 (Hepilor)

Details and patient eligibility

About

Irradiation of level III and IV draining nodes in breast cancer patients is often associated with dysphagia, requiring treatment with FANS and/or steroids. The present randomized phase III trial determined whether Zinc-L-Carnosine ( Hepilor), prevents or delays the onset of dysphagia in these patients.

Full description

. This is a randomized phase III prospective placebo-controlled trial with patients recruited from one single university teaching hospital. Inclusion criteria were: age ≥18 years, breast cancer patients who were candidates for post-operative RT by means of HeT to the breast /chest wall and SC/IC nodes (III-IV levels).Exclusion criteria were: pregnancy or lactation, known or suspected hypersensitivity or allergy to ZLC or to any of the excipients in its oral solution.

All patients were randomized by a pre-determined computer code to two groups.

1. HEPILOR arm: patients received ZLC solution
2. Placebo arm: patients received a placebo solution Toxicity was assessed weekly in all patients immediately before or after the RT session. Acute toxicity was defined as occurring during RT or in 30 days after it ended and assessed using the Common Terminology Criteria for Adverse Events (CTCAE 4.0 scale). Dysphagia was assessed weekly by means of EAT 10, a self-administered questionnaire

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥18 years
• breast cancer patients who were candidates for post-operative RT by means of HeT to the breast /chest wall and SC/IC nodes (III-IV levels).

Exclusion criteria

• pregnancy or lactation
• known or suspected hypersensitivity or allergy to ZLC or to any of the excipients in its oral solution.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Hepilor arm

Experimental group

Description:

patients received ZLC solution. The prescribed dose was 10 ml, in the morning and evening, between meals.

Treatment:

Device: Hepilor

Placebo arm

Placebo Comparator group

Description:

Patients received a placebo solution. The prescribed dose was 10 ml, in the morning and evening, between meals

Treatment:

Device: Hepilor