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


Phase 1/Phase 2
N/A
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of patients who have prolonged survival after receiving Oncoxin

Outcome Description:

To study the number of participants who have prolonged survival after receiving Oncoxin for 24 weeks.

Outcome Time Frame:

48 weeks

Safety Issue:

Yes

Principal Investigator

Mamun A Mahtab, MSc MD FACG

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Authority:

Bangladesh: Directorate of Drug Administration

Study ID:

OP1

NCT ID:

NCT01392131

Start Date:

July 2011

Completion Date:

July 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Oncoxin
  • Safety of Oncoxin
  • Therapeutic efficacy of Oncoxin
  • Improvement of quality of life with Oncoxin
  • Survival benefit with Oncoxin
  • Carcinoma
  • Carcinoma, Hepatocellular

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