Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC)

Study Overview
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Brief Summary
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Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma

Detailed Description
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To assess therapeutic efficacy and safety of Oncoxin in hepatocellular carcinoma To see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of Oncoxin To see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of Oncoxin To see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of Oncoxin To see if there is improved survival in hepatocellular carcinoma patients after administration of oncoxin

Official Title
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Study to Evaluate Safety and Therapeutic Efficacy of a Nutritional Supplement 'Oncoxin' in Patients With Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Dietary Supplement: Oncoxin
* Other: Supportive treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with HCC irrespective of etiology, age, gender and status of underlying liver disease. Patients with HCC who are not suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy. Patients with HCC who have evidence of tumor metastasis Patients with HCC who are voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy. Patients with HCC in whom all possible treatment options have been exhausted. Exclusion Criteria: Patients with HCC who are suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy. Patients with HCC who have no evidence of tumor metastasis Patients with HCC who are willing to take established modalities of treatment i.e. surgery and/or chemotherapy. Patients with HCC who are voluntarily unwilling to be included in the trial
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oncoxin will be administered orally<br>20 patients will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks | Dietary Supplement: Oncoxin<br>* 20 patients with hepatocellular carcinoma will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks<br>* Other names: Viusid;|
| Active Comparator: Supportive treatment<br>20 patients with hepatocellular carcinoma will receive supportive treatment only | Other: Supportive treatment<br>* patients will receive only supportive treatment. No chemotherapy, radiotherapy, tumor ablation or surgery will be performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who have prolonged survival after receiving Oncoxin | To study the number of participants who have prolonged survival after receiving Oncoxin for 24 weeks. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in serum alpha-fetoprotein level and decrease in tumor size | To see whether Oncoxin results in reduction in serum alpha-fetoprotein level and decrease in tumor size in hepatocellular carcinoma patients off treatment for 24 weeks, after receiving Oncoxin for 24 weeks. | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncoxin, Safety of Oncoxin, Therapeutic efficacy of Oncoxin, Improvement of quality of life with Oncoxin, Survival benefit with Oncoxin