Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Clinical Research Organization, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:
NCT01392131
First received: July 7, 2011
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Hepatocellular Carcinoma
Dietary Supplement: Oncoxin
Other: Supportive treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Evaluate Safety and Therapeutic Efficacy of a Nutritional Supplement 'Oncoxin' in Patients With Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Clinical Research Organization, Dhaka, Bangladesh:

Primary Outcome Measures:
  • Number of patients who have prolonged survival after receiving Oncoxin [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    To study the number of participants who have prolonged survival after receiving Oncoxin for 24 weeks.


Secondary Outcome Measures:
  • Reduction in serum alpha-fetoprotein level and decrease in tumor size [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oncoxin will be administered orally
20 patients will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks
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 Name: Viusid
Active Comparator: Supportive treatment
20 patients with hepatocellular carcinoma will receive supportive treatment only
Other: Supportive treatment
patients will receive only supportive treatment. No chemotherapy, radiotherapy, tumor ablation or surgery will be performed

Detailed 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392131

Locations
Bangladesh
Farabi General Hospital
Dhaka, Bangladesh, 1205
Sponsors and Collaborators
Clinical Research Organization, Dhaka, Bangladesh
Investigators
Principal Investigator: Mamun A Mahtab, MSc MD FACG Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  More Information

No publications provided

Responsible Party: Clinical Research Organization, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT01392131     History of Changes
Other Study ID Numbers: OP1
Study First Received: July 7, 2011
Last Updated: December 11, 2012
Health Authority: Bangladesh: Directorate of Drug Administration

Keywords provided by Clinical Research Organization, Dhaka, Bangladesh:
Oncoxin
Safety of Oncoxin
Therapeutic efficacy of Oncoxin
Improvement of quality of life with Oncoxin
Survival benefit with Oncoxin

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on August 18, 2014