National Institute of Oncology and Radiobiology (INOR)
Havana, 10400, Cuba
NCT Number: NCT03562897
Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.
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Notify Me18 year and older
Female
Interventional
Phase 2
Havana, 10400, Cuba
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 4 months
It will measured by: - EORTC QLQ-C30 (Points of every item and final points)
Time frame: 4 months
Karnofsky index (Score of 0-100 points at intervals of 10)
Time frame: 4 months
EORTC QLQ-OV28 (Points of every item and final points)
Time frame: 4 months
Body mass index
Catalysis SL
Industry
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.
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