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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00689195

Acronym

OSCAT

Enrollment

Registered

2008-06-03

Start date

2008-05-31

Completion date

2013-06-30

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteosarcoma

Keywords

Curcumin, Ashwagandha, osteosarcoma, Pharmacokinetics of curcumin and ashwagandha formulation, response

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 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

Interventions

DIETARY_SUPPLEMENTCurcumin powder

oral capsules containing the investigational agent

DIETARY_SUPPLEMENTAshwagandha extract

4.5% extract of ashwagandha

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
response, toxicity, disease progression	2 years

Secondary

Measure	Time frame
quality of life	2 years

Countries

India

Contacts

Primary ContactManish Agarwal, M.S(Orth), D.N.B(Orth)

mgagarwal@gmail.com91-22-2444-7189

Backup ContactVikram S Gota, M.D

vikramgota@gmail.com91-22-2417-7000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026