NCT03540407

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2015

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

4.1 years

First QC Date

May 3, 2018

Last Update Submit

January 22, 2020

Conditions

Cervical Carcinoma Stage IICervical Carcinoma Stage IIICervical Carcinoma Stage IVEndometrial Adenocarcinoma Stage IIEndometrial Adenocarcinoma Stage IIIEndometrial Adenocarcinoma Stage IV

Keywords

Cervical carcinomaEndometrial adenocarcinomaOncoxin-ViusidNutritional supplementAntioxidant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • quality of life

    3 months

  • Reduce hospital costs

    3 months

  • Quality of life

    3 months

Study Arms (2)

Oncoxin-Viusid®

EXPERIMENTAL

will receive the Oncoxin-Viusid® (oral solution) concomitant to the onco-specific treatment.

Dietary Supplement: Oncoxin-Viusid®

Placebo

PLACEBO COMPARATOR

will receive a Placebo concomitant to the onco-specific treatment

Dietary Supplement: Placebo

Interventions

Oncoxin-Viusid®DIETARY_SUPPLEMENT

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

Oncoxin-Viusid®
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramón González Coro Hospital

La Habana, 10400, Cuba

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Raiza Ruiz Llorente, Dr.

    Ramón González Coro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
A double blind
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 30, 2018

Study Start

January 7, 2015

Primary Completion

February 1, 2019

Study Completion

September 30, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

CU(1)