Clinical trial NCT03997188: Zinc-L-Carnosine Prevents Dysphagia in Breast Cancer Patients Undergoing Adjuvant Radiotherapy
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer Female
Dysphagia
Adjuvant Radiotherapy
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Zinc-L-Carnosine prevents dysphagia in breast cancer patients undergoing adjuvant radiotherapy: clinical outcome assessed by Eating Assessment Tool (EAT-10) questionaire
timeFrame: once a week during the radiotherapy and once at first month of follow-up
measure: Degree of dysphagia
timeFrame: only in the presence of dysphagia:once a week during the radiotherapy and once at first month of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: University of Perugia
Study officials:
affiliation: University Of Perugia
name: Cynthia Aristei, MD
role: PRINCIPAL_INVESTIGATOR
References: