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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Tata Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
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

May 23, 2008
June 22, 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 ClinicalTrials.gov 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
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteosarcoma
  • 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
    Curcumin
    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
24
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)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00689195
381
Yes
Not Provided
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