Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma

Conditions
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Osteosarcoma

Intervention / Treatment
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* Dietary Supplement: Curcumin powder
* Dietary Supplement: Ashwagandha extract


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C<br>Curcumin | Dietary Supplement: Curcumin powder<br>* oral capsules containing the investigational agent<br>* Other names: M3CX,;|
| Experimental: A<br>Ashwagandha extract | Dietary Supplement: Ashwagandha extract<br>* 4.5% extract of ashwagandha<br>* Other names: Indian Ginseng;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response, toxicity, disease progression |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curcumin, Ashwagandha, osteosarcoma, Pharmacokinetics of curcumin and ashwagandha formulation, response