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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
oral capsules containing the investigational agent
4.5% extract of ashwagandha
Tata Memorial Hospital
Mumbai, Maharashtra, India
RECRUITINGresponse, toxicity, disease progression
Time frame: 2 years
quality of life
Time frame: 2 years
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