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

Primary Purpose

Cervical Carcinoma Stage II, Cervical Carcinoma Stage III, Cervical Carcinoma Stage IV

Status

Completed

Phase

Phase 2

Locations

Cuba

Study Type

Interventional

Intervention

Oncoxin-Viusid®

Placebo

About this trial

This is an interventional supportive care trial for Cervical Carcinoma Stage II focused on measuring Cervical carcinoma, Endometrial adenocarcinoma, Oncoxin-Viusid, Nutritional supplement, Antioxidant

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Ramón González Coro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oncoxin-Viusid®

Placebo

Arm Description

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

will receive a Placebo concomitant to the onco-specific treatment

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

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

Full Information

NCT ID

NCT03540407

First Posted

May 3, 2018

Last Updated

January 22, 2020

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT03540407

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

January 7, 2015 (Actual)

Primary Completion Date

February 1, 2019 (Actual)

Study Completion Date

September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Catalysis SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Cervical carcinoma, Endometrial adenocarcinoma, Oncoxin-Viusid, Nutritional supplement, Antioxidant

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

A double blind

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oncoxin-Viusid®

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

will receive a Placebo concomitant to the onco-specific treatment

Intervention Type

Dietary Supplement

Intervention Name(s)

Oncoxin-Viusid®

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Toxicity of chemotherapy and radiotherapy in patients diagnosed with cervical cancer and endometrium adenocarcinoma.

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

quality of life

Description

Self-perceived quality of life related to health through the EORTC test QLQ-C30 at the beginning and at the end of the treatment.

Time Frame

3 months

Title

Reduce hospital costs

Description

Time Frame

3 months

Title

Quality of life

Description

Self-perceived quality of life related to health through the EORTC test QLQ-CX24 at the beginning and at the end of the treatment

Time Frame

3 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raiza Ruiz Llorente, Dr.

Organizational Affiliation

Ramón González Coro Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ramón González Coro Hospital

City

La Habana

ZIP/Postal Code

10400

Country

Cuba

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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