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. 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

May 23, 2008
June 3, 2008
June 23, 2011
May 2008
June 2013   (Final data collection date for primary outcome measure)
response, toxicity, disease progression [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00689195 on Archive Site
quality of life [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma
Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"
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.

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
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Dietary Supplement: Curcumin powder
    oral capsules containing the investigational agent
    Other Name: M3CX,
  • Dietary Supplement: Ashwagandha extract
    4.5% extract of ashwagandha
    Other Names:
    • Withania somnifera,
    • Dunal,
    • Indian Ginseng
  • Experimental: C
    Intervention: Dietary Supplement: Curcumin powder
  • Experimental: A
    Ashwagandha extract
    Intervention: Dietary Supplement: Ashwagandha extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2013
June 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
8 Years to 65 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dr Manish Agarwal, Tata Memorial Hospital
Tata Memorial Hospital
Pharmanza Herbals Pvt Limited (PHPL)
Not Provided
Tata Memorial Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP