Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01392131
• Other study ID #: OP1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: July 7, 2011
• Last updated: December 11, 2012
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: December 2012
• Source: Clinical Research Organization, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Directorate of Drug Administration
• Study type: Interventional

Clinical Trial Summary

Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Dietary Supplement:
• Oncoxin
20 patients with hepatocellular carcinoma will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks

Other:
• Supportive treatment
patients will receive only supportive treatment. No chemotherapy, radiotherapy, tumor ablation or surgery will be performed

Locations

Country	Name	City	State
Bangladesh	Farabi General Hospital	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Research Organization, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No