Trials / Completed
CompletedNCT03717298
Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma
Evaluation of the Effect of Ocoxin-Viusid® Nutritional Supplement in the Life Quality in Patients Diagnosed With Advanced Pancreatic Adenocarcinoma. Phase II
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Catalysis SL · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-10-30
- Primary completion
- 2022-12-01
- Completion
- 2023-01-20
- First posted
- 2018-10-24
- Last updated
- 2023-03-28
Locations
1 site across 1 country: Cuba
Source: ClinicalTrials.gov record NCT03717298. Inclusion in this directory is not an endorsement.