Pilot Study of Curcumin Formulation and Ashwagandha Extra... | NCT00689195

Studies
Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma

NCT00689195

Sponsor

Tata Memorial Hospital

Status

Unknown status

Last Update Posted

Jun 23, 2011Estimated

Enrollment

24Estimated

Phase

Phase 1Phase 2

Conditions

Osteosarcoma

Interventions

Curcumin powder
Ashwagandha extract

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Jun 2013Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

May 23, 2008

First Submission Date that Met QC Criteria

May 29, 2008

First Posted Date

Jun 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Name	Class
Pharmanza Herbals Pvt Limited (PHPL)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
C	Experimental	Curcumin	Dietary Supplement: Curcumin powder
A	Experimental	Ashwagandha extract	Dietary Supplement: Ashwagandha extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Curcumin powder	Dietary Supplement	oral capsules containing the investigational agent	C

Measure	Description	Time Frame
response, toxicity, disease progression		2 years

Measure	Description	Time Frame
quality of life		2 years

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Manish Agarwal, M.S(Orth), D.N.B(Orth)	Contact	91-22-2444-7189		mgagarwal@gmail.com
Vikram S Gota, M.D	Contact	91-22-2417-7000	4537	vikramgota@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tata Memorial Hospital	Recruiting	Mumbai	Maharashtra	400012	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41685666	Derived	Heo JU, Rao S, Newton HB, Dowlati A, Muzic RF Jr, Kardan A. Phase 1 Trial of Withania somnifera Leaf Extract (RH324) in Advanced Non-Small Cell Lung Cancer Including [18F]FDG PET/CT as a Short-Term Metabolic Biomarker to Assess Efficacy: A Novel Model for Assessment of Complimentary Therapies in Early Phase Human Clinical Trials. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251410182. doi: 10.1177/15347354251410182. Epub 2026 Feb 13.

ID	Term
D018213	Neoplasms, Bone Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type