MedTrace Logo

Evaluation of Oncoxin-Viusid® in Cervical Cancer and Endometrial Adenocarcinoma.

NCT03540407 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-01-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of oral solution Oncoxin-Viusid in the reduction of acute toxicity of Radiotherapy (RTP) and Chemotherapy (QTP) in patients with histological diagnosis of cervical cancer and endometrial adenocarcinoma. This is a phase II, prospective, randomized and double blind clinical trial, which will include 66 patients assigned to 2 treatment arms: 33 patients will receive conventional treatment, plus a placebo of the nutritional supplement and another 33 patients will receive along with the conventional treatment the Oncoxin-Viusid nutritional supplement produced by the Catalysis Laboratories of Spain. Patients will receive oral treatment throughout the onco-specific treatment and up to 3 weeks after completion.

Conditions

  • Cervical Carcinoma Stage II
  • Cervical Carcinoma Stage III
  • Cervical Carcinoma Stage IV
  • Endometrial Adenocarcinoma Stage II
  • Endometrial Adenocarcinoma Stage III
  • Endometrial Adenocarcinoma Stage IV

Interventions

DIETARY_SUPPLEMENT

Oncoxin-Viusid®

Administration of the Oncoxin-Viusid® oral solution 25 mL three times a day during the concurrent Radiotherapy and Chemotherapy treatment and up to 3 weeks after the end of the onco-specific treatment

DIETARY_SUPPLEMENT

Placebo

Administration of the Oncoxin-Viusid® oral solution placebo 25 ml three times a day during the concurrent Radiotherapy and Chemotherapy treatment and up to 3 weeks after the end of the onco-specific treatment

Sponsors & Collaborators

  • Catalysis SL

    lead INDUSTRY

Principal Investigators

  • Raiza Ruiz Llorente, Dr. · Ramón González Coro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-07
Primary Completion
2019-02-01
Completion
2019-09-30

Countries

  • Cuba

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03540407 on ClinicalTrials.gov