To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer (NCT05969314) | Clinical Trial Compass
Active — Not RecruitingPhase 1
To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer
India12 participantsStarted 2022-06-08
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Planned for any other pre or peri-operative intervention such as neoadjuvant chemotherapy or targeted therapy or radiation
✕. 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
✕. Pregnancy and/or lactation
✕. Patients currently (within last 14 days before consenting) on other CNS depressants such as alcohol, barbiturates, benozodiazapines (like diazepam, alprazolam etc)
✕. 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
What they're measuring
1
To establish safe dose of oral cannabis preparation