NCT03540407

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Catalysis SL · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2015-01-07
• Primary completion: 2019-02-01
• Completion: 2019-09-30
• First posted: 2018-05-30
• Last updated: 2020-01-23

Locations

1 site across 1 country: Cuba