Clinical trial · Interventional
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"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ashwagandha extract | Dietary Supplement | — | UNRESOLVED |
| Curcumin powder | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- C
- description
- Curcumin
- interventionNames
- Dietary Supplement: Curcumin powder
- type
- EXPERIMENTAL
- label
- A
- description
- Ashwagandha extract
- interventionNames
- Dietary Supplement: Ashwagandha extract
Primary outcomes (1)
- measure
- response, toxicity, disease progression
- timeFrame
- 2 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHeo 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. PMID 41685666