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Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC)

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
Bangladesh
Study Type
Interventional
Intervention
Oncoxin
Supportive treatment
Sponsored by
Clinical Research Organization, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Oncoxin, Safety of Oncoxin, Therapeutic efficacy of Oncoxin, Improvement of quality of life with Oncoxin, Survival benefit with Oncoxin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Farabi General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oncoxin will be administered orally

Supportive treatment

Arm Description

20 patients will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks

20 patients with hepatocellular carcinoma will receive supportive treatment only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 7, 2011
Last Updated
December 11, 2012
Sponsor
Clinical Research Organization, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT01392131
Brief Title
Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC)
Official Title
Study to Evaluate Safety and Therapeutic Efficacy of a Nutritional Supplement 'Oncoxin' in Patients With Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Research Organization, Dhaka, Bangladesh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Oncoxin, Safety of Oncoxin, Therapeutic efficacy of Oncoxin, Improvement of quality of life with Oncoxin, Survival benefit with Oncoxin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oncoxin will be administered orally
Arm Type
Active Comparator
Arm Description
20 patients will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks
Arm Title
Supportive treatment
Arm Type
Active Comparator
Arm Description
20 patients with hepatocellular carcinoma will receive supportive treatment only
Intervention Type
Dietary Supplement
Intervention Name(s)
Oncoxin
Other Intervention Name(s)
Viusid
Intervention Description
20 patients with hepatocellular carcinoma will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks
Intervention Type
Other
Intervention Name(s)
Supportive treatment
Intervention Description
patients will receive only supportive treatment. No chemotherapy, radiotherapy, tumor ablation or surgery will be performed
Primary Outcome Measure Information:
Title
Number of patients who have prolonged survival after receiving Oncoxin
Description
To study the number of participants who have prolonged survival after receiving Oncoxin for 24 weeks.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Reduction in serum alpha-fetoprotein level and decrease in tumor size
Description
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.
Time Frame
48 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mamun A Mahtab, MSc MD FACG
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Farabi General Hospital
City
Dhaka
ZIP/Postal Code
1205
Country
Bangladesh

12. IPD Sharing Statement

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Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC)

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