To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer

NCT05969314 | Active Not Recruiting Phase 1 DMC

• 2 other identifiers: TMH Project No. 3386CTRI/2020/06/020649
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer; Oral Cancer

Outcome Measures

Primary Outcomes (1)

• To establish safe dose of oral cannabis preparation

  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

  From day 1 of IP dosing till 28 days .

Secondary Outcomes (2)

• Pharmacokinetic profiling

  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

• Biomarker analysis- Transcitpomics

  A baseline pre-cannabis tumor tissue sample will be collected before starting IP(day 0). Further blood and tumor as well as adjacent normal tissue samples will be collected during surgery (day6).

Study Arms (1)

Cannabis

EXPERIMENTAL

Cannabis capsules containing 5 mg of THC and CBD each or 2.5 mg of THC and CBD each.

Drug: Cannabis capsules

Interventions

Cannabis capsules DRUG

Cannabis capsules containing 5 mg of THC and CBD each or 2.5 mg of THC and CBD each.

Cannabis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Any other illness or abnormal laboratory investigations which the investigator considers as making the patients ineligible for the study
• Any patient with positive HIV, HBsAg, HCV status

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (2)

Tata Memorial Center

Mumbai, Maharashtra, 400012, India

Location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (27)

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MeSH Terms

Conditions

Breast Neoplasms; Mouth Neoplasms

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Head and Neck Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Rajendra A Badwe, MS

  Director, Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: To determine the maximum tolerated dose (MTD). First 3 patients will receive the study preparation once a day at 9 am (+/- 60 min) (i.e 5 mg of CBD and 5 mg of THC in a 400 mg capsule). Subsequent cohorts will be administered doses of 10 (10 mg of THC and CBD each), 20 (20+20) and 30 (30+30) mg in a classical 3+3 dose escalation study. Briefly, 3 patients will be enrolled at dose level. Dose escalation to the next dose level will continue as long no DLT is observed in 3 patients (the incidence of DLT is ≤ 1/6) In any cohort, if 1/3 patients develop DLT, then 3 more patients will be added at that dose. The dose level at which more than 1/6 patients develop DLT will be considered the MTD and no further escalation will be done beyond the MTD. One dose level below the MTD will be considered for future trials. If MTD is not achieved, the highest dose (30+30) will be considered for future trials. If toxicity is seen at 30 mg, then de-escalation to 25 mg may be considered.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: August 1, 2023
• Study Start: June 8, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)