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Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma (OSCAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00689195
Recruitment Status : Unknown
Verified June 2011 by Tata Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : June 3, 2008
Last Update Posted : June 23, 2011
Pharmanza Herbals Pvt Limited (PHPL)
Information provided by:
Tata Memorial Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Osteosarcoma Dietary Supplement: Curcumin powder Dietary Supplement: Ashwagandha extract Phase 1 Phase 2

Detailed Description:

Eligibility criteria

  1. Osteosarcoma which has relapsed after treatment and for which no second line chemotherapy is planned and in which disease is not amenable to surgery.
  2. Patient should be able to follow-up 3 monthly for clinical and imaging assessment as well as biochemical tests

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"
Study Start Date : May 2008
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: C
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:
  • Withania somnifera,
  • Dunal,
  • Indian Ginseng

Primary Outcome Measures :
  1. response, toxicity, disease progression [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. quality of life [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689195

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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

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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)
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Responsible Party: Dr Manish Agarwal, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00689195    
Other Study ID Numbers: 381
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011
Keywords provided by Tata Memorial Hospital:
Pharmacokinetics of curcumin and ashwagandha formulation
Additional relevant MeSH terms:
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Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action