NCT03997188 is a Phase 3 clinical trial of Hepilor in Breast Cancer Female, sponsored by Cynthia Aristei.

Who is sponsoring NCT03997188?

NCT03997188 is sponsored by Cynthia Aristei.

What drugs are being tested in NCT03997188?

Interventions in NCT03997188: Hepilor.

What condition does NCT03997188 study?

NCT03997188 studies Breast Cancer Female, Dysphagia, Adjuvant Radiotherapy.

Is NCT03997188 still recruiting?

NCT03997188 is currently completed. Last updated 25 June 2019.

Last reviewed 2019-06-25 · How we verify

NCT03997188

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 25 June 2019

What this trial tests

Phase 3 trial testing Hepilor in Breast Cancer Female in 40 participants. Completed in 20 December 2017.

Timeline

21 December 2015

Primary endpoint
14 November 2017

20 December 2017

Quick facts

Lead sponsor	Cynthia Aristei
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	21 December 2015
Primary completion	14 November 2017
Estimated completion	20 December 2017
Sites	1 location across Italy

Drugs / interventions tested

Hepilor

Conditions studied

Breast Cancer Female — all drugs for Breast Cancer Female →
Dysphagia — all drugs for Dysphagia →
Adjuvant Radiotherapy — all drugs for Adjuvant Radiotherapy →

Sponsor

Cynthia Aristei

Who can join

18 and older, female only, with Breast Cancer Female or Dysphagia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Radiomitigators: Breakthroughs in Post-Radiation Recovery.
Obrador E, Estrela JM, López-Blanch R, Moreno-Murciano P, et al · · 2026 · PMID 41897526 · DOI 10.3390/antiox15030381

Verify or expand the search:

Other recruiting trials for Breast Cancer Female

Currently open trials in the same condition.

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NCT07331506 — Validation of the Oncoliq Test for the Early Detection of Breast Cancer. · recruiting
NCT07214883 — UCF MammoChat: Image Repository · recruiting
NCT07120100 — Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy in Breast and Gynecologic Cancer Surviv · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03997188 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cynthia Aristei
Last refreshed: 25 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03997188.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing