NCT00689195

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"

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: All
• Age: 8 Years – 65 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Curcumin powder	oral capsules containing the investigational agent
DIETARY_SUPPLEMENT	Ashwagandha extract	4.5% extract of ashwagandha

Timeline

• Start date: 2008-05-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2008-06-03
• Last updated: 2011-06-23

Locations

1 site across 1 country: India