Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00689195
• Date of registration: 23/05/2008
• Prospective Registration: No
• Primary sponsor: Tata Memorial Hospital
• Public title: Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma OSCAT
• Scientific title: Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"
• Date of first enrolment: May 2008
• Target sample size: 24
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00689195
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

India

Contacts

• Name: Manish Agarwal, M.S(Orth)

• Name: Manish Agarwal, M.S(Orth), D.N.B(Orth)

Key inclusion & exclusion criteria

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.



Age minimum: 8 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Osteosarcoma

Intervention(s)

Dietary Supplement: Ashwagandha extract

Dietary Supplement: Curcumin powder

Primary Outcome(s)

response, toxicity, disease progression [Time Frame: 2 years]

Secondary Outcome(s)

quality of life [Time Frame: 2 years]

Secondary ID(s)

381

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pharmanza Herbals Pvt Limited (PHPL)