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Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocoxin-ViusidĀ® | Experimental | Ocoxin-ViusidĀ® before, during and after the Chemotherapy treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocoxin-Viusid | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | It will measured by: - EORTC QLQ-C30 (Points of every item and final points) | 4 months |
| Quality of life | Karnofsky index (Score of 0-100 points at intervals of 10) | 4 months |
| Quality of life | EORTC QLQ-OV28 (Points of every item and final points) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional State | Body mass index | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Oncology and Radiobiology (INOR) | Havana | 10400 | Cuba |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22987944 | Background | Prat J. New insights into ovarian cancer pathology. Ann Oncol. 2012 Sep;23 Suppl 10:x111-7. doi: 10.1093/annonc/mds300. | |
| 21521830 | Background | Jelovac D, Armstrong DK. Recent progress in the diagnosis and treatment of ovarian cancer. CA Cancer J Clin. 2011 May-Jun;61(3):183-203. doi: 10.3322/caac.20113. Epub 2011 Apr 26. |
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|
| 25559415 | Background | Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5. |
| 18195328 | Background | Landen CN Jr, Birrer MJ, Sood AK. Early events in the pathogenesis of epithelial ovarian cancer. J Clin Oncol. 2008 Feb 20;26(6):995-1005. doi: 10.1200/JCO.2006.07.9970. Epub 2008 Jan 14. |
| 23945413 | Background | Fuchs-Tarlovsky V, Alvarez-Altamirano K, Turquie-Sacal D, Alvarez-Flores C, Hernandez-Steller H. Nutritional status and body composition are already affected before oncology treatment in ovarian cancer. Asia Pac J Clin Nutr. 2013;22(3):426-30. doi: 10.6133/apjcn.2013.22.3.12. |
| 19484479 | Background | Gupta D, Lis CG, Vashi PG, Lammersfeld CA. Impact of improved nutritional status on survival in ovarian cancer. Support Care Cancer. 2010 Mar;18(3):373-81. doi: 10.1007/s00520-009-0670-y. Epub 2009 May 31. |
| 20803205 | Background | Kathiresan AS, Brookfield KF, Schuman SI, Lucci JA 3rd. Malnutrition as a predictor of poor postoperative outcomes in gynecologic cancer patients. Arch Gynecol Obstet. 2011 Aug;284(2):445-51. doi: 10.1007/s00404-010-1659-y. Epub 2010 Aug 29. |
| 21843153 | Background | Madhok BM, Yeluri S, Haigh K, Burton A, Broadhead T, Jayne DG. Parenteral nutrition for patients with advanced ovarian malignancy. J Hum Nutr Diet. 2011 Apr;24(2):187-91. doi: 10.1111/j.1365-277X.2010.01127.x. |
| 24027084 | Background | Billson HA, Holland C, Curwell J, Davey VL, Kinsey L, Lawton LJ, Whitworth AJ, Burden S. Perioperative nutrition interventions for women with ovarian cancer. Cochrane Database Syst Rev. 2013 Sep 11;2013(9):CD009884. doi: 10.1002/14651858.CD009884.pub2. |
| 25216721 | Background | Lohsiriwat V. The influence of preoperative nutritional status on the outcomes of an enhanced recovery after surgery (ERAS) programme for colorectal cancer surgery. Tech Coloproctol. 2014 Nov;18(11):1075-80. doi: 10.1007/s10151-014-1210-4. Epub 2014 Sep 13. |
| 9713300 | Background | Andreyev HJ, Norman AR, Oates J, Cunningham D. Why do patients with weight loss have a worse outcome when undergoing chemotherapy for gastrointestinal malignancies? Eur J Cancer. 1998 Mar;34(4):503-9. doi: 10.1016/s0959-8049(97)10090-9. |
| 10559547 | Background | Lamson DW, Brignall MS. Antioxidants in cancer therapy; their actions and interactions with oncologic therapies. Altern Med Rev. 1999 Oct;4(5):304-29. |
| 11302780 | Background | Lamson DW, Brignall MS. Natural agents in the prevention of cancer, part two: preclinical data and chemoprevention for common cancers. Altern Med Rev. 2001 Apr;6(2):167-87. |
| 26905163 | Background | Al-Mahtab M, Akbar SM, Khan MS, Rahman S. Increased survival of patients with end-stage hepatocellular carcinoma due to intake of ONCOXIN(R), a dietary supplement. Indian J Cancer. 2015 Jul-Sep;52(3):443-6. doi: 10.4103/0019-509X.176699. |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D014565 | Urogenital Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005833 | Genital Neoplasms, Female |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000611825 | Ocoxin |
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