Hepatocellular CarcinomaPhase 1/2NCT01392131
Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC)
A Phase 1/2 study testing Oncoxin and Supportive treatment in people with Hepatocellular Carcinoma, run by Clinical Research Organization, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Oncoxin and Supportive treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBangladesh
- Study dates
- Jul 2011to Jul 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Evaluate Safety and Therapeutic Efficacy of a Nutritional Supplement 'Oncoxin' in Patients With Hepatocellular Carcinoma
Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma
Read the 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
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Oncoxin, Supportive treatment
- Keywords
- Oncoxin, Safety of Oncoxin, Therapeutic efficacy of Oncoxin, Improvement of quality of life with Oncoxin, Survival benefit with Oncoxin
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoxinDietary supplement
Also called Viusid
20 patients with hepatocellular carcinoma will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks
Supportive treatmentOther
patients will receive only supportive treatment. No chemotherapy, radiotherapy, tumor ablation or surgery will be performed
| Study group | Role | What they receive |
|---|---|---|
| Oncoxin will be administered orally | Active comparator | 20 patients will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks Receives: Dietary Supplement: Oncoxin |
| Supportive treatment | Active comparator | 20 patients with hepatocellular carcinoma will receive supportive treatment only Receives: Other: Supportive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (1)
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.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Organization, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mamun A Mahtab, MSc MD FACG, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392131
- Sponsor's protocol ID
- OP1
- Status last verified
- Dec 2012
- First submitted
- 7 Jul 2011
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Safety and Therapeutic Efficacy of a Nutritional Supplement 'Oncoxin' in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01392131
- Acronym / sponsor ID
- OP1
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Oncoxin, Safety of Oncoxin, Therapeutic efficacy of Oncoxin, Improvement of quality of life with Oncoxin, Survival benefit with Oncoxin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinical Research Organization, Dhaka, BangladeshUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncoxin will be administered orally | Active comparator | Dietary Supplement: Oncoxin20 patients will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks |
| Supportive treatment | Active comparator | Other: Supportive treatment20 patients with hepatocellular carcinoma will receive supportive treatment only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OncoxinAlso: Viusid20 patients with hepatocellular carcinoma will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks | Dietary supplement | Oncoxin will be administered orally |
| Supportive treatmentpatients will receive only supportive treatment. No chemotherapy, radiotherapy, tumor ablation or surgery will be performed | Other | Supportive treatment |
Primary outcome
Number of patients who have prolonged survival after receiving Oncoxin
Time frame: 48 weeks
To study the number of participants who have prolonged survival after receiving Oncoxin for 24 weeks.
1 secondary outcome
Reduction in serum alpha-fetoprotein level and decrease in tumor size
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mamun A Mahtab, MSc MD FACG principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oncoxin and Supportive treatment in people with Hepatocellular Carcinoma, run by Clinical Research Organization, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who have prolonged survival after receiving Oncoxin (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.