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

• Sponsor: Cynthia Aristei (Other)
• Overall Status: Completed
• CT.gov ID: NCT03997188
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female; Dysphagia; Adjuvant Radiotherapy	Device: Hepilor	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Study for the Evaluation of the Impact of HEPILOR on the Possible Delay in the Development of Dysphagia in Breast Cancer Patients Undergoing Adjuvant Radiotherapy on the Breast/Thoracic Wall and Lymph Node Drainage.
• Actual Study Start Date: Dec 21, 2015
• Actual Primary Completion Date: Nov 14, 2017
• Actual Study Completion Date: Dec 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hepilor arm patients received ZLC solution. The prescribed dose was 10 ml, in the morning and evening, between meals.	Device: Hepilor; 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.; Other Names: Placebo
Placebo Comparator: Placebo arm Patients received a placebo solution. The prescribed dose was 10 ml, in the morning and evening, between meals	Device: Hepilor; 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.; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Perugia	Perugia		Italy	06132

Sponsors and Collaborators

• Cynthia Aristei

Investigators

• Principal Investigator: Cynthia Aristei, MD, University Of Perugia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cynthia Aristei, Professor, University Of Perugia
• ClinicalTrials.gov Identifier: NCT03997188
• Other Study ID Numbers: 003 (Hepilor)
• First Posted: Jun 25, 2019
• Last Update Posted: Jun 25, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Deglutition Disorders

Study Results

No Results Posted as of Jun 25, 2019