NCT05969314Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 31 May 2022
- Start date
- 8 Jun 2022
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Tata Memorial Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT05969314
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- From 8 Jun 2022 to the primary completion date, 30 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned for any other pre or peri-operative intervention such as neoadjuvant chemotherapy or targeted therapy or radiation
- Patients currently (within last 14 days before consenting) on other CNS depressants such as alcohol, barbiturates, benozodiazapines (like diazepam, alprazolam etc)
Other illness
- 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)
- History of substance abuse (including cannabis-related products) or alcohol abuse
- Personal history of psychiatric disease or Significant family history of psychiatric disease
- Any patient with positive HIV, HBsAg, HCV status
Lab values
- 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
- Any other illness or abnormal laboratory investigations which the investigator considers as making the patients ineligible for the study
Other
- Pregnancy and/or lactation
Who the study is looking for
- Histopathologically proven patients of breast or oral cavity SCC
- Age \> 18 and \< 65
- Operable cancers planned to undergo upfront curative surgery
- Patient fit for surgery (ASA Grade I / II)
- Patient Voluntarily willing to give consent for study
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Tata Memorial Center Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.