Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03717298|
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Pancreas Pancreatic Cancer Advanced Cancer Digestive System Neoplasms Pancreatic Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Endocrine System Diseases Pancreatic Diseases||Dietary Supplement: Ocoxin-Viusid®||Phase 2|
To assess the effect of Ocoxin-Viusid® on the quality of life of patients with advanced pancreatic adenocarcinoma.
To evaluate the effect of Ocoxin-Viusid® on the quality of life of patients. To evaluate the influence of Ocoxin-Viusid® on tolerance to onco-specific therapy.
Identify the changes that occur in the nutritional status of patients receiving the supplement.
To evaluate the toxicity of Ocoxin-Viusid® in combination with chemotherapy in patients with advanced pancreatic adenocarcinoma.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of the Effect of Ocoxin-Viusid® Nutritional Supplement in the Life Quality in Patients Diagnosed With Advanced Pancreatic Adenocarcinoma. Phase II|
|Actual Study Start Date :||October 30, 2018|
|Estimated Primary Completion Date :||October 30, 2019|
|Estimated Study Completion Date :||December 15, 2019|
It will be used at a rate of 60 ml daily (1 vial every 12 hours).
Dietary Supplement: Ocoxin-Viusid®
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.
- Quality of Life: EORTC QLQ-C30 [ Time Frame: 12 months ]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.
- Nutritional Status of the patient during Chemotherapy [ Time Frame: 12 months ]Variations in the patient's nutritional status will be considered, measured by body mass Index (a measure of body fat based on height and weight that applies to adult men and women)
- Adverse Events-AE during Chemotherapy Test [ Time Frame: 12 months ]
A test with the following questions:
Occurrence of an AE in the subject [Yes, No]; Description of the AE [Name of the event]; Duration of the AE [Difference between the start and end date of the event]; Intensity of the AE [According to CTCAE version 4 it will classify in Light, Moderate, Severe, Life-threatening consequences, Death related to AE]; Seriousness of the AE [serious or not serious], Attitude with respect to the treatment under study [No changes, dose modification, temporary or definitive interruption of the study treatment], Result of the AE [recovered, improved, persisted or sequelae], Causal relationship [According to WHO algorithm it will classify in very probable, probable, possible, improbable, unrelated, not evaluable]
- Hematology test [ Time Frame: 12 months ]Levels of Hemoglobin, Platelets, Hemogram with differential in blood extractions.
- Blood Chemistry test [ Time Frame: 12 months ]Measure levels of GPT, GOT, Creatinine, Glycemia, Bilirrubin, Alkaline Phosphatase, LDH in blood.
- Compliance with the treatment with chemotherapy (CT) and Immunotherapy (IT) test [ Time Frame: 12 months ]Test with the next parameters: if the administration of chemotherapy (CT) and Immunotherapy (IT) treatments will be considered at planned time, number of the cycle administered out of date, days elapsed since the previous cycle and, cause that caused the administration of the CT/IT outside the planned date. In the case of the dose, the medication in which it was modified will be taken into account, as well as the modified dose.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717298
|Contact: Ivis Mendoza Hernández, MSc||7 204 firstname.lastname@example.org|
|Contact: Yaima Muñoz Morejón, Dr.||7 204 email@example.com|
|"Hermanos Ameijeiras" Surgical Clinical Hospital||Recruiting|
|La Habana, Cuba, 10300|
|Contact: Mayté Lima Pérez, Dr. firstname.lastname@example.org|
|Contact: Juan L. Soriano García, Dr. email@example.com|
|Principal Investigator: Mayte Lima Pérez, Dr.|
|Principal Investigator: Jorge L. Soriano García, Dr.|
|Sub-Investigator: Vilma Fleites Calvo, Dr.|
|Sub-Investigator: Jorge Ortiz, Dr.|
|Sub-Investigator: María E. Suardiaz, MSc|
|Sub-Investigator: Yolanda Hernández García, NP|
|Sub-Investigator: Amarilis Grau Cascudo, NP|
|Sub-Investigator: Ivelisse Fleites, BSc|
|Sub-Investigator: Carlos Domínguez, Dr.|
|Sub-Investigator: Robin García Diéguez, BSc|
|Sub-Investigator: Angela Gutiérrez, Dr.|