Clinical trial · Interventional
To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer
Phase I Study of Safety and Feasibility of Ayurvedic Oral Cannabis Preparation in the Peri-operative Period in Breast and Oral Cavity Squamous Cell Cancer
NCT05969314CI-TRIAL-00088451active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Phase 1 study to assess the pharmacokinetic availability and safety and tolerability profile of one such ayurvedic preparation which contains 5 mg THC:CBD 1:1 preparation. Other than the PK profile, we will also be studying its effect on gene expression profiling of the breast and head neck oral cavity squamous cell carcinoma tissue.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cannabis capsules | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cannabis
- description
- Cannabis capsules containing 5 mg of THC and CBD each or 2.5 mg of THC and CBD each.
- interventionNames
- Drug: Cannabis capsules
Primary outcomes (1)
- measure
- To establish safe dose of oral cannabis preparation
- timeFrame
- From day 1 of IP dosing till 28 days .
- description
- Number of participants with treatment-related adverse events with respect to cardiovascular, central nervous system and psychotropic of cannabis as assessed by CTCAE v4.0
Secondary outcomes (2)
- measure
- Pharmacokinetic profiling
- timeFrame
- 1.Pre operative day 1 to 5 - one each day before cannabinoid dosing, after dosing 30 minutes, 1 hour, 2 hour and 8 hour. 2. On day of surgery - Before and after the surgery 3. Post operative day 1 , day 2, day 3 and day 14
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically proven patients of breast or oral cavity SCC 2. Age \> 18 and \< 65 3. Operable cancers planned to undergo upfront curative surgery 4. Patient fit for surgery (ASA Grade I / II) 5. Patient Voluntarily willing to give consent for study Exclusion Criteria: 1. Planned for any other pre or peri-operative intervention such as neoadjuvant chemotherapy or targeted therapy or radiation 2. Presence of medical disease such as pulmonary, renal, liver, gastro-intestinal disease which may interfere with any study specific procedure (deranged renal parameters \> 1.5 times normal range or deranged liver function tests such as \> 2.5 times raised liver enzymes) 3. History of substance abuse (including cannabis-related products) or alcohol abuse 4. Personal history of psychiatric disease or Significant family history of psychiatric disease 5. Pregnancy and/or lactation 6. Patients currently (within last 14 days before consenting) on other CNS depressants such as alcohol, barbiturates, benozodiazapines (like diazepam, alprazolam etc) 7. Patients on other medications which will likely have a drug interaction with cannabis- such as clozapine, duloxetine, naproxen, cyclobenzaprine, olanzapine, haloperidol, and chlorpromazine, macrolides, calcium channel blockers, benzodiazepines, cyclosporine, sildenafil (and other PDE5 inhibitors), antihistamines, haloperidol, antiretrovirals 8. Any other illness or abnormal laboratory investigations which the investigator considers as making the patients ineligible for the study 9. Any patient with positive HIV, HBsAg, HCV status
References
Publications (27)
- BACKGROUNDZuardi AW. History of cannabis as a medicine: a review. Braz J Psychiatry. 2006 Jun;28(2):153-7. doi: 10.1590/s1516-44462006000200015. Epub 2006 Jun 26. PMID 16810401
- BACKGROUNDElSohly MA, Radwan MM, Gul W, Chandra S, Galal A. Phytochemistry of Cannabis sativa L. Prog Chem Org Nat Prod. 2017;103:1-36. doi: 10.1007/978-3-319-45541-9_1. PMID 28120229
- BACKGROUNDBen Amar M. Cannabinoids in medicine: A review of their therapeutic potential. J Ethnopharmacol. 2006 Apr 21;105(1-2):1-25. doi: 10.1016/j.jep.2006.02.001. Epub 2006 Mar 15. PMID 16540272
- BACKGROUNDWhiting PF, Wolff RF, Deshpande S, Di Nisio M, Duffy S, Hernandez AV, Keurentjes JC, Lang S, Misso K, Ryder S, Schmidlkofer S, Westwood M, Kleijnen J. Cannabinoids for Medical Use: A Systematic Review and Meta-analysis. JAMA. 2015 Jun 23-30;313(24):2456-73. doi: 10.1001/jama.2015.6358. PMID 26103030
- BACKGROUNDBar-Sela G, Vorobeichik M, Drawsheh S, Omer A, Goldberg V, Muller E. The medical necessity for medicinal cannabis: prospective, observational study evaluating the treatment in cancer patients on supportive or palliative care. Evid Based Complement Alternat Med. 2013;2013:510392. doi: 10.1155/2013/510392. Epub 2013 Jul 16. PMID 23956774
- BACKGROUNDWaissengrin B, Urban D, Leshem Y, Garty M, Wolf I. Patterns of use of medical cannabis among Israeli cancer patients: a single institution experience. J Pain Symptom Manage. 2015 Feb;49(2):223-30. doi: 10.1016/j.jpainsymman.2014.05.018. Epub 2014 Jun 14. PMID 24937161
- BACKGROUNDVara D, Salazar M, Olea-Herrero N, Guzman M, Velasco G, Diaz-Laviada I. Anti-tumoral action of cannabinoids on hepatocellular carcinoma: role of AMPK-dependent activation of autophagy. Cell Death Differ. 2011 Jul;18(7):1099-111. doi: 10.1038/cdd.2011.32. Epub 2011 Apr 8.