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

Catalysis SL

Status and phase

Completed

Phase 2

Conditions

Cervical Carcinoma Stage III

Endometrial Adenocarcinoma Stage III

Endometrial Adenocarcinoma Stage II

Endometrial Adenocarcinoma Stage IV

Cervical Carcinoma Stage II

Cervical Carcinoma Stage IV

Treatments

Dietary Supplement: Oncoxin-Viusid®

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03540407

OOS-CANCER-3

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No 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.