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

NCT ID: NCT03540407

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-07
• Study Completion Date: 2019-09-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Oncoxin-Viusid®

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

Group Type: EXPERIMENTAL

Oncoxin-Viusid®

Intervention Type: 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

Placebo

will receive a Placebo concomitant to the onco-specific treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Catalysis SL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raiza Ruiz Llorente, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ramón González Coro Hospital

Locations

Ramón González Coro Hospital

La Habana, , Cuba

Countries

Cuba

Other Identifiers

OOS-CANCER-3

Identifier Type: -

Identifier Source: org_study_id