Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma (OSCAT)
This study is currently recruiting participants.
Verified June 2011 by Tata Memorial Hospital
Sponsor:
Tata Memorial Hospital
Collaborator:
Pharmanza Herbals Pvt Limited (PHPL)
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00689195
First received: May 23, 2008
Last updated: June 22, 2011
Last verified: June 2011
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Purpose
Curcumin as well as the ashwagandha extract are ingredients from traditional indian medicine and have been shown to be potent anti-cancer compounds in laboratory as well as animal studies. This study will test the safety and efficacy of a curcumin formulation and the ashwagandha extract in high grade relapsed or metastatic osteosarcoma where no other second line chemotherapy is being given. The pharmacokinetics will be studied along with response as measured on CT scans and PET scans as well as the quality of life and any toxicity.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteosarcoma |
Dietary Supplement: Curcumin powder Dietary Supplement: Ashwagandha extract |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma" |
Resource links provided by NLM:
Further study details as provided by Tata Memorial Hospital:
Primary Outcome Measures:
- response, toxicity, disease progression [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: C
Curcumin
|
Dietary Supplement: Curcumin powder
oral capsules containing the investigational agent
Other Name: M3CX,
|
|
Experimental: A
Ashwagandha extract
|
Dietary Supplement: Ashwagandha extract
4.5% extract of ashwagandha
Other Names:
|
Detailed Description:
Eligibility criteria
- Osteosarcoma which has relapsed after treatment and for which no second line chemotherapy is planned and in which disease is not amenable to surgery.
- Patient should be able to follow-up 3 monthly for clinical and imaging assessment as well as biochemical tests
Eligibility| Ages Eligible for Study: | 8 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients (between the ages of 8 to 65 years) with histologically proven high grade osteosarcoma of the extremity and relapsed disease after primary line of treatment who are unsuitable or refuse secondary chemotherapy.
- Patients with advanced disease unable or unwilling to take primary conventional treatment
- Patients with early or non-metastatic disease who are unable or unwilling to take the standard chemotherapy.
- Adequate hepatic function defined by total bilirubin not more than 1.5 times the upper limit of normal (ULN) and SGOT and SGPT not more than 2.5 times the (ULN)
- Adequate renal function defined by the creatinine clearance greater than 50 ml/min, calculated by cockcroft-Gault formula
Exclusion Criteria:
- Patients who are suitable for second line chemotherapy and can afford it
- Age less than 8 years or greater than 65 years
- Pregnant or lactating women
- Patients who are unable or unwilling to provide blood samples for the drug assays.
- Low grade osteosarcoma
- Patient requiring treatment with CYP3A4 inducers or inhibitors (patients on treatment for epilepsy or tuberculosis)
- Participation in any investigational drug study within 28 days prior to study treatment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689195
Contacts
| Contact: Manish Agarwal, M.S(Orth), D.N.B(Orth) | 91-22-2444-7189 | mgagarwal@gmail.com |
| Contact: Vikram S Gota, M.D | 91-22-2417-7000 ext 4537 | vikramgota@gmail.com |
Locations
| India | |
| Tata Memorial Hospital | Recruiting |
| Mumbai, Maharashtra, India, 400012 | |
| Contact: Manish Agarwal, M.S(Orth) 91-22-2444-7189 mgagarwal@gmail.com | |
| Contact: Vikram S Gota, M.D 91-22-2417-7000 ext 4537 vikramgota@gmail.com | |
| Principal Investigator: Manish Agarwal, M.S(Orth) | |
Sponsors and Collaborators
Tata Memorial Hospital
Pharmanza Herbals Pvt Limited (PHPL)
More Information
No publications provided
| Responsible Party: | Dr Manish Agarwal, Tata Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00689195 History of Changes |
| Other Study ID Numbers: | 381 |
| Study First Received: | May 23, 2008 |
| Last Updated: | June 22, 2011 |
| Health Authority: | India: Drugs Controller General of India |
Keywords provided by Tata Memorial Hospital:
|
Curcumin Ashwagandha osteosarcoma Pharmacokinetics of curcumin and ashwagandha formulation response |
Additional relevant MeSH terms:
|
Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Curcumin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013