Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma

NCT03717298 | Completed Phase 2 DMC

• 1 other identifier: OOS-CANCER-6
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical Hospital. Phase II clinical trial, open, multicenter, nonrandomized.

Conditions

Adenocarcinoma of the Pancreas; Pancreatic Cancer; Advanced Cancer; Digestive System Neoplasms; Pancreatic Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Endocrine System Diseases; Pancreatic Diseases

Keywords

Nutritional supplement; Advanced Pancreatic adenocarcinoma; Ocoxin-Viusid; Oxidative stress; Antioxidant

Outcome Measures

Primary Outcomes (1)

• Quality of Life: EORTC QLQ-C30

  Life quality measurement through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (ORTC QLQ-C30): an integrated system for assessing the healthrelated quality of life (QoL) of cancer patients participating in international clinical trials. It's composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

  12 months

Secondary Outcomes (5)

• Nutritional Status of the patient during Chemotherapy

  12 months

• Adverse Events-AE during Chemotherapy Test

  12 months

• Hematology test

  12 months

• Blood Chemistry test

  12 months

• Compliance with the treatment with chemotherapy (CT) and Immunotherapy (IT) test

  12 months

Study Arms (1)

Ocoxin-Viusid

EXPERIMENTAL

It will be used at a rate of 60 ml daily (1 vial every 12 hours).

Dietary Supplement: Ocoxin-Viusid®

Interventions

Ocoxin-Viusid® DIETARY_SUPPLEMENT

An oral solution of Ocoxin-Viusid® (30 ml vials) will be used at a rate of 60 ml daily (1 vial every 12 hours), preferably administered after breakfast and lunch. It will be prescribed for a period of 2 weeks before starting the QT. The treatment with Ocoxin-Viusid® will continue in the possible periods of time of suspension of the chemotherapy treatment due to toxicities attributable to the oncospecific treatment. The treatment will be administered continuously from the inclusion of the patient in the study, up to one year.

Ocoxin-Viusid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years.
• Patients that meet the diagnostic criteria.
• Patients with general health according to Karnofsky ≥70 %.
• Life expectancy greater than or equal to 3 months.
• Patients eligible to receive chemotherapy.
• Patients who have signed the informed consent.
• Patients who have laboratory values in parameters that do not contraindicate the administration of chemotherapy:
• Hemoglobin ≥ 90 g / l.
• Total Leukocyte Count ≥ 3.0 x 109 / L.
• Absolute Neutrophil Count ≥1.5 x 109 / L.
• Platelet count ≥100 x 109 / L.
• Total bilirubin values ≤ 1.5 times the upper limit of the normal range established in the institution.
• TGO and TGP values ≤2.5 times the upper limit of the normal interval established in the institution.
• Creatinine values within the normal limits of the institution.

You may not qualify if:

• Pregnant or lactating patients.
• Patients with known hypersensitivity to any of the active ingredients of the chemotherapy used
• Patients who are receiving another product under investigation.
• Patients with decompensated intercurrent diseases, including: hypertension, diabetes mellitus, ischemic heart disease, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that at the discretion of the doctor puts their health at risk and his life during the study or his participation in the trial.
• Patients with brain metastases.
• Patients with mental disorders that may limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.
• It is planned to include a total of 30 patients in the study, taking into account 10% of losses.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

"Hermanos Ameijeiras" Surgical Clinical Hospital

La Habana, 10300, Cuba

Location

Related Publications (11)

• Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403.

  PMID: 9196156 BACKGROUND

• Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

  PMID: 21561347 BACKGROUND

• Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

  PMID: 24131140 BACKGROUND

• Tobita K, Kijima H, Dowaki S, Kashiwagi H, Ohtani Y, Oida Y, Yamazaki H, Nakamura M, Ueyama Y, Tanaka M, Inokuchi S, Makuuchi H. Epidermal growth factor receptor expression in human pancreatic cancer: Significance for liver metastasis. Int J Mol Med. 2003 Mar;11(3):305-9.

  PMID: 12579331 BACKGROUND

• Burris H 3rd, Rocha-Lima C. New therapeutic directions for advanced pancreatic cancer: targeting the epidermal growth factor and vascular endothelial growth factor pathways. Oncologist. 2008 Mar;13(3):289-98. doi: 10.1634/theoncologist.2007-0134.

  PMID: 18378539 BACKGROUND

• Ueda S, Ogata S, Tsuda H, Kawarabayashi N, Kimura M, Sugiura Y, Tamai S, Matsubara O, Hatsuse K, Mochizuki H. The correlation between cytoplasmic overexpression of epidermal growth factor receptor and tumor aggressiveness: poor prognosis in patients with pancreatic ductal adenocarcinoma. Pancreas. 2004 Jul;29(1):e1-8. doi: 10.1097/00006676-200407000-00061.

  PMID: 15211117 BACKGROUND

• Korc M, Meltzer P, Trent J. Enhanced expression of epidermal growth factor receptor correlates with alterations of chromosome 7 in human pancreatic cancer. Proc Natl Acad Sci U S A. 1986 Jul;83(14):5141-4. doi: 10.1073/pnas.83.14.5141.

  PMID: 3014534 BACKGROUND

• Immervoll H, Hoem D, Kugarajh K, Steine SJ, Molven A. Molecular analysis of the EGFR-RAS-RAF pathway in pancreatic ductal adenocarcinomas: lack of mutations in the BRAF and EGFR genes. Virchows Arch. 2006 Jun;448(6):788-96. doi: 10.1007/s00428-006-0191-8. Epub 2006 Apr 6.

  PMID: 16598499 BACKGROUND

• Lee J, Jang KT, Ki CS, Lim T, Park YS, Lim HY, Choi DW, Kang WK, Park K, Park JO. Impact of epidermal growth factor receptor (EGFR) kinase mutations, EGFR gene amplifications, and KRAS mutations on survival of pancreatic adenocarcinoma. Cancer. 2007 Apr 15;109(8):1561-9. doi: 10.1002/cncr.22559.

  PMID: 17354229 BACKGROUND

• Russo A, Rizzo S, Bronte G, Silvestris N, Colucci G, Gebbia N, Bazan V, Fulfaro F. The long and winding road to useful predictive factors for anti-EGFR therapy in metastatic colorectal carcinoma: the KRAS/BRAF pathway. Oncology. 2009;77 Suppl 1:57-68. doi: 10.1159/000258497. Epub 2010 Feb 2.

  PMID: 20130433 BACKGROUND

• da Cunha Santos G, Dhani N, Tu D, Chin K, Ludkovski O, Kamel-Reid S, Squire J, Parulekar W, Moore MJ, Tsao MS. Molecular predictors of outcome in a phase 3 study of gemcitabine and erlotinib therapy in patients with advanced pancreatic cancer: National Cancer Institute of Canada Clinical Trials Group Study PA.3. Cancer. 2010 Dec 15;116(24):5599-607. doi: 10.1002/cncr.25393. Epub 2010 Sep 7.

  PMID: 20824720 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Endocrine System Diseases; Pancreatic Diseases

Interventions

Ocoxin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 24, 2018
• Study Start: October 30, 2018
• Primary Completion: December 1, 2022
• Study Completion: January 20, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CU (1)