Evaluation of Oncoxin-Viusid® in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03543670|
Recruitment Status : Active, not recruiting
First Posted : June 1, 2018
Last Update Posted : June 5, 2018
A not randomized clinical survey was done in 25 pacients with histological diagnosis confirmed of a prostatic adenocarcinoma and hardy in hormonotherapy at the Calixto Garcia Hospital in Habana (2016-2018).
Researches had as identifying goal the efecctiveness study of Oncoxin-Viusid® nutritional supplement as a support to convencional treatment. The patient were treated with habitual doses of Docetacel and 75 mg per day of supplement during and fiften day after the quimiotherapy. The rest of numbers and severety of adverse reactions were determined as well as its influences on life quality when this co-therapy is performed, the evaluation of progresion spare survival and the porcentage of recurrences.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: Oncoxin-Viusid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficacy of Oncoxin-Viusin® Nutritional Supplement Related With the Onco-specific Treatments in Prostate Cancer Patients|
|Actual Study Start Date :||September 16, 2017|
|Actual Primary Completion Date :||April 12, 2018|
|Estimated Study Completion Date :||November 30, 2018|
Dietary Supplement: Oncoxin-Viusid
Support treatment with Oncoxin-Viusid (75mL/day) during chemotherapy/Radiotherapy until two weeks after (a total of 8 months).
- Quality of Life [ Time Frame: 12 months ]General quality of life (EORTC QLQ C30 questionnaire and specific for prostate cancer EORTC QLQ - PR25)
- Adverse events [ Time Frame: 12 months ]Toxicity (hematological, hemochemistry, clinical response) stablished by WHO
- Overal survival [ Time Frame: 12 months ]Global Survival Rate (GSR)
- Overal recurrences [ Time Frame: 12 months ]Progression-free survival - PFS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543670
|General Calixto García University Hospital|
|La Habana, Cuba, 10400|
|Principal Investigator:||Mercedes I. Fundora, Dr.||General Calixto García University Hospital|