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

Phase 3

Completed

• Conditions: Dysphagia; Breast Cancer Female; Adjuvant Radiotherapy
• Interventions: Device: Hepilor

• Registration Number: NCT03997188
• Lead Sponsor: Cynthia Aristei

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2015-12-21
• Primary Completion: 2017-11-14
• Study Completion: 2017-12-20
• Status Verified: 2019-06
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-22
• Last Update Submitted: 2019-06-22
• Study First Posted: 2019-06-25
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hepilor arm	Hepilor	patients received ZLC solution. The prescribed dose was 10 ml, in the morning and evening, between meals.
Placebo arm	Hepilor	Patients received a placebo solution. The prescribed dose was 10 ml, in the morning and evening, between meals

Primary Outcome Measures

Name	Time	Method
Zinc-L-Carnosine prevents dysphagia in breast cancer patients undergoing adjuvant radiotherapy: clinical outcome assessed by Eating Assessment Tool (EAT-10) questionaire	once a week during the radiotherapy and once at first month of follow-up	The Primary end-point was no dysphagia. The study aim is to assess whether the medical device is able to avoid or delay the onset of dysphagia. The patients were evaluated before the start of radiotherapy and weekly to identify the possible appearance of dysphagia. Dysphagia was assessed weekly by means of self-assessment EAT10 questionnaire that is a tool used to assess objectively the presence of dysphagia, in details (0 = No problem 4 = Severe problem): 1. My swallowing problem has caused me to lose weight; 2. My swallowing problem interferes with my ability to go out for meals; 3. Swallowing liquids takes extra effort; 4. Swallowing solids takes extra effort; 5. Swallowing pills takes extra effort; 6. Swallowing is painful; 7. The pleasure of eating is affected by my wallowing; 8. When I swallow food sticks in my throat; 9. I cough when I eat; 10. Swallowing is stressful.
Degree of dysphagia	only in the presence of dysphagia:once a week during the radiotherapy and once at first month of follow-up	The degree of dysphagia was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) 4.0 scale.; When the patient showed a score of the questionnaire greater than 3 the target was reached dysphagia was present and this was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Dysphagia =Grade 1: Symptomatic, able to eat regular diet. Grade 2: Symptomatic and altered eating/swallowing. Grade 3: Severely altered eating/swallowing; tube feeding or TPN or hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death.

Trial Locations

Locations (1)

University of Perugia; 🇮🇹 Perugia, Italy