NCT03562897

Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer

Efficacy of the Oncoxin-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced or Metastatic Ovarian Epithelial Cancer. Clinical Trial Phase II.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Catalysis SL · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.

Detailed description

General Objectives -To identify the efficacy of the nutritional supplement Ocoxin-viusid to increase the quality of life of patients with epithelial advanced or metastatic ovarian cancer. Specific Objectives - Identify the influence of the research product on the nutritional status and quality of life of patients. - Describe the toxicity of the research product. - Identify the adverse reactions to the chemotherapy scheme and quantify the interruptions to it by acute toxicity. Quality of life. It will be measured as: - EORTC Questionnaire QLQ-C30 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - EORTC Questionnaire QLQ-OV28 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - Karnofsky index (Score of 0-100 points at intervals of 10). Measurement time: at the beginning, in each cycle of QT and 3 weeks after the 3rd cycle of QT

Conditions

• Carcinoma
• Ovarian Neoplasm
• Endocrine Gland Neoplasm
• Urogenital Neoplasms
• Ovarian Diseases
• Adnexal Diseases
• Genital Diseases, Female
• Female Urogenital Diseases
• Female Urogenital Diseases and Pregnancy Complications
• Endocrine System Diseases
• Gonadal Disorders
• Genital Neoplasm, Female
• Neoplasms, Glandular and Epithelial

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ocoxin-Viusid	Ocoxin-Viusid group (Experimental): Oral solution Ocoxin-Viusid (30 ml vials) were used at a rate of 60ml / day (1 vial every 12 hours), preferably administered after breakfast and dinner. The treatment will start a week before start Chemotheray treatment (CT) and, It will maintenance until 3 weeks after finished the last cycle of CT (3 cycles of CT of Carboplatin/Paclitaxel or Cisplatin/ Paclitaxel with neoadjuvant intent).

Timeline

• Start date: 2018-10-25
• Primary completion: 2022-02-15
• Completion: 2022-06-15
• First posted: 2018-06-20
• Last updated: 2022-07-06

Locations

1 site across 1 country: Cuba