Evaluate the effect of Nutraceutical Product (Onconeem) in patients with oral squamous cell carcinoma
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2022/12/048616
- Lead Sponsor
- isarga Biotech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients with histologically confirmed, locally advanced and/or metastatic OSCC who are candidate for palliative chemotherapy or palliative radiotherapy as approved by the investigator.
2.Patients with adequate organ system function.
3.ECOG performance status of 0-2.
4.Life expectancy of at least 12 weeks.
5.Males and females >= 18 years of age.
6.Ability to swallow and retain oral medication.
7.Women of child-bearing potential with a negative serum pregnancy test.
8.Male should consent to use effective method of contraception and abstain from donating sperm, throughout the study period and for 12 weeks after the last dose of study drug.
9. Willingness and ability to comply with trial and follow-up procedures.
10. Ability to understand the nature of this trial and give written informed consent.
1.Other cancer therapy such as immunotherapy or biologic therapy in the last 3 weeks or the last 5 T½ of the agent, whichever is shorter.
2.Patient has severe (Grade 3) adverse event of any previous cancer therapy.
3.Use of any investigational drug in the last 3 weeks or 5 T½ (whichever is shorter) prior to the first dose of study drug.
4. Known history of severe liver injury that includes drug-induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension.
5.Any severe and/or uncontrolled medical conditions or other conditions that in the opinion of Principal Investigator could affect their participation in the study.
6.Patient on any other alternative medications (ayurvedic, homeopathy or unani medicine). (There preparations/ medications should be discontinued 48 hours prior to first dose of study drug).
7.Presence of other active cancers at the time of enrollment.
8.Women who are pregnant or lactating.
9.Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
10.Concurrent condition that in the investigatorâ??s opinion would jeopardize compliance with the protocol.
11.Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method