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

Efficacy of the Oncoxin-Viusid® Oral Solution in Reducing the Adverse Reactions of Chemotherapy and Radiotherapy in Patients Diagnosed With Cervical Cancer and Endometrial Adenocarcinoma.

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.

Study Overview

• Status: Completed
• 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
• Intervention / Treatment: Dietary supplement: Oncoxin-Viusid®; Dietary supplement: Placebo

Detailed Description

Patients will be evaluated clinically and hematological at the beginning of the treatment, before each cycle of treatment with QTP / RTP, at month, two and three months after the end of the treatment with follow-up every three months for 1 year. The self-perceived quality of life related to health will be assessed by means of the EORTC questionnaires (QLQ-C30 and the specific questionnaire QLQ-CX24) at the beginning and a year after completing the treatment. The toxicity to the research product will be described according to Common Criteria of Terminology for the Report of Adverse Events (CTCAE version 4) and the tolerance to onco-specific treatment. It is expected that with the joint administration of the research product, the patients will have a better tolerance to the treatment of QTP / RTP with a decrease of the interruptions by toxicity in 25% and will preserve a better quality of life.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• Cuba
  • La Habana, Cuba, 10400
    • Ramón González Coro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients with histological confirmation of cervical cancer and adenocarcinoma of the endometrium that are treated with chemotherapy and ionizing radiation.
• Patient with age equal to or greater than 18 years and up to 80 years.
• Patients who do not present decompensated concurrent diseases at the time of diagnosis that prevent or contraindicate the application of treatment with chemo-radiotherapy.
• Informed consent to participate in the investigation.
• Patients with an ECOG <or equal to 3.

Exclusion Criteria:

• Patients with a history of renal failure that contraindicates the administration of cisplatin.
• Concomitant diseases unbalanced at the time of diagnosis or during the application of treatment.
• Patients with an ECOG> 3.
• Pregnant or lactating women.
• Patients who are receiving another research product.
• Patients who do not show consent to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oncoxin-Viusid®; will receive the Oncoxin-Viusid® (oral solution) concomitant to the onco-specific treatment.	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
PLACEBO_COMPARATOR: Placebo; will receive a Placebo concomitant to 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity of chemotherapy and radiotherapy in patients diagnosed with cervical cancer and endometrium adenocarcinoma.	Patients diagnosed with cervical cancer and adenocarcinoma of the endometrium usually have varying degrees of malnutrition and immunodeficiencies; they are carriers of oncogenic virus infections, and present deterioration of their general state, depression-anxiety and socio-economic dysfunctions. Oncospecific treatment's toxicity is measured according to Common Criteria of Terminology for the Report of Adverse Events (CTCAE version 4).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life	Self-perceived quality of life related to health through the EORTC test QLQ-C30 at the beginning and at the end of the treatment.	3 months
Reduce hospital costs	Reduce hospital costs by being unnecessary or decreasing, the use of concomitant support treatments that counteract the adverse effects caused by these, hospitalization for the treatment of complications secondary to the treatment of QTP / RTP and the use of antibiotics in cases of neutropenia / leukopenia and sepsis added, very frequent in these patients.	3 months
Quality of life	Self-perceived quality of life related to health through the EORTC test QLQ-CX24 at the beginning and at the end of the treatment	3 months

Collaborators and Investigators

• Sponsor: Catalysis SL
• Investigators: Principal Investigator: Raiza Ruiz Llorente, Dr., Ramón González Coro Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2015
• Primary Completion (ACTUAL): February 1, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (ACTUAL): May 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Antioxidant; Nutritional supplement; Cervical carcinoma; Endometrial adenocarcinoma; Oncoxin-Viusid
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Uterine Diseases; Carcinoma; Adenocarcinoma; Uterine Neoplasms
• Other Study ID Numbers: OOS-CANCER-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No