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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05969314
• Other study ID #: TMH Project No. 3386
• Secondary ID: CTRI/2020/06/020
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 8, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: Tata Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The ancient Ayurvedic medicine obtained from Cannabis sativa plant has recently been re-explored for its anti-inflammatory and anti-cancer potential. Various laboratory and preclinical studies have proven its anti-cancer activity and its effect on all the hallmarks of cancer. Anecdotal clinical evidence has shown regression of tumours with ingestion of such medicinal cannabis. A randomized controlled trial in Glioblastoma Multiforme, a kind of brain tumour, shows improvement in disease free survival when temozolamide was combined with Cannabis spray called Sativex.

However, because of lack of systematic, large volume studies, the evidence is slow to emerge. We have previously seen changes related to NF-kb (inflammation) and AP1 (acute hypoxia/stress) pathway genes within the tumour tissue as assessed by transcriptomic analysis (Yet unpublished data). There is laboratory evidence to suggest that the changes induced in the AP1 pathway during surgery can be ameliorated by cannabis treatment. We intend to explore this anticancer potential of C sativa herbal preparation in the pre-operative setting in breast and head and neck cancer patients. Hence, we are proposing a 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Mouth Neoplasms
• Oral Cancer

Intervention

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

Locations

Country	Name	City	State
India	Tata Memorial Center	Mumbai	Maharashtra
India	Tata Memorial Hospital	Mumbai	Maharastra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

References & Publications (27)

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Vandrey R, Herrmann ES, Mitchell JM, Bigelow GE, Flegel R, LoDico C, Cone EJ. Pharmacokinetic Profile of Oral Cannabis in Humans: Blood and Oral Fluid Disposition and Relation to Pharmacodynamic Outcomes. J Anal Toxicol. 2017 Mar 1;41(2):83-99. doi: 10.1093/jat/bkx012. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetic profiling	Blood samples collected during the administration of the IP for 5 days and up to 72 hours after surgery.	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
Secondary	Biomarker analysis- Transcitpomics	Tumor and normal tissue samples.	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).