OsteosarcomaPhase 1/2OSCATNCT00689195
Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma
A Phase 1/2 study testing Curcumin powder and Ashwagandha extract in people with Osteosarcoma, run by Tata Memorial Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 65 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Curcumin powder and Ashwagandha extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- May 2008to Jun 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Manish Agarwal, M.S(Orth), 91-22-2444-7189, mgagarwal@gmail.com
Vikram S Gota, M.D, 91-22-2417-7000 ext. 4537, vikramgota@gmail.com
About this study
Official title: Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"
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.
Read the 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
- Conditions
- Osteosarcoma
- Being tested
- Curcumin powder, Ashwagandha extract
- Keywords
- Curcumin, Ashwagandha, osteosarcoma, Pharmacokinetics of curcumin and ashwagandha formulation, response
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin powderDietary supplement
Also called M3CX,
oral capsules containing the investigational agent
Ashwagandha extractDietary supplement
Also called Withania somnifera,, Dunal,, Indian Ginseng
4.5% extract of ashwagandha
| Study group | Role | What they receive |
|---|---|---|
| C | Experimental | Curcumin Receives: Dietary Supplement: Curcumin powder |
| A | Experimental | Ashwagandha extract Receives: Dietary Supplement: Ashwagandha extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
response, toxicity, disease progression
Measured: 2 years
Secondary outcomes (1)
quality of life
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Collaborators
- Pharmanza Herbals Pvt Limited (PHPL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689195
- Sponsor's protocol ID
- 381
- Acronym
- OSCAT
- Status last verified
- Jun 2011
- First submitted
- 23 May 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41685666
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"
- ClinicalTrials.gov ID
- NCT00689195
- Acronym / sponsor ID
- OSCAT / 381
- Conditions
- Osteosarcoma
- Keywords
- Curcumin, Ashwagandha, osteosarcoma, Pharmacokinetics of curcumin and ashwagandha formulation, response
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Collaborators
- Pharmanza Herbals Pvt Limited (PHPL)
- Study start
- May 2008
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C | Experimental | Dietary Supplement: Curcumin powderCurcumin |
| A | Experimental | Dietary Supplement: Ashwagandha extractAshwagandha extract |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin powderAlso: M3CX,oral capsules containing the investigational agent | Dietary supplement | C |
| Ashwagandha extractAlso: Withania somnifera,, Dunal,, Indian Ginseng4.5% extract of ashwagandha | Dietary supplement | A |
Primary outcome
response, toxicity, disease progression
Time frame: 2 years
1 secondary outcome
quality of life
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Derived from this study: PubMed 41685666Heo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Curcumin powder and Ashwagandha extract in people with Osteosarcoma, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manish Agarwal, M.S(Orth), D.N.B(Orth) (91-22-2444-7189, mgagarwal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response, toxicity, disease progression (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00689195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011; AzTrials last refreshed its copy on 7 Nov 2026.