Clinical Trial: Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"
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.
Detailed Summary:
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
Sponsor: Tata Memorial Hospital
Current Primary Outcome: response, toxicity, disease progression [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: quality of life [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Tata Memorial Hospital
Dates:
Date Received: May 23, 2008
Date Started: May 2008
Date Completion: June 2013
Last Updated: June 22, 2011
Last Verified: June 2011
