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

NCT03997188 | Completed Phase 3

• 1 other identifier: 003 (Hepilor)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female; Dysphagia; Adjuvant Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Zinc-L-Carnosine prevents dysphagia in breast cancer patients undergoing adjuvant radiotherapy: clinical outcome assessed by Eating Assessment Tool (EAT-10) questionaire

  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.

  once a week during the radiotherapy and once at first month of follow-up

• Degree of dysphagia

  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.

  only in the presence of dysphagia:once a week during the radiotherapy and once at first month of follow-up

Study Arms (2)

Hepilor arm

EXPERIMENTAL

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

Device: Hepilor

Placebo arm

PLACEBO COMPARATOR

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

Device: Hepilor

Interventions

Hepilor DEVICE

ZLC oral suspension and placebo were both started on Day 1 of RT-HeT and ended when RT was completed or at the onset of dysphagia.

Also known as: Placebo

Hepilor arm; Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Cynthia Aristei: lead

Study Sites (1)

University of Perugia

Perugia, 06132, Italy

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Cynthia Aristei, MD

  University Of Perugia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: note Study Phase\* A medical device is a substance; whose purpose is comparable to the drug ( therapy, prevention, diagnosis, restoration of functions), but it is different from the drug because the drug acts with pharmacological, metabolic and immunological means, while the medical device acts through a mechanical action. Hepilor is a medical device in the form of a syrup with specific properties to protect and repair the gastro-intestinal mucosa. The functional substances of the medical device (Zinc-L-Carnosine and Sodium Alginate) thanks to their mucoadhesive properties act as a physical barrier protecting the damaged areas. In consideration of this we have designed a randomized phase III to to determine whether ZLC prevented or delayed esophagitis in breast cancer patients undergoing HeT to SC/IC lymph nodes and residual breast or chest wall.

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 25, 2019
• Study Start: December 21, 2015
• Primary Completion: November 14, 2017
• Study Completion: December 20, 2017
• Last Updated: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)