To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer
NCT ID: NCT05969314
Last Updated: 2025-04-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE1
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-06-08
Study Completion Date
2025-06-30
Brief Summary
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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.
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Detailed Description
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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and AP1 (acute hypoxia/stress) pathway genes within the tumour tissue as assessed by transcriptomic analysis (Yet unpublished data).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.
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.
Conditions
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Breast Cancer
Oral Cancer
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Cannabis
Cannabis capsules containing 5 mg of THC and CBD each or 2.5 mg of THC and CBD each.
Group Type
EXPERIMENTAL
Cannabis capsules
Intervention Type
DRUG
Cannabis capsules containing 5 mg of THC and CBD each or 2.5 mg of THC and CBD each.
Interventions
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Cannabis capsules
Cannabis capsules containing 5 mg of THC and CBD each or 2.5 mg of THC and CBD each.
Intervention Type
DRUG
Eligibility Criteria
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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
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
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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Tata Memorial Hospital
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Dr Rajendra A. Badwe
Doctor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Rajendra A Badwe, MS
Role: PRINCIPAL_INVESTIGATOR
Director, Tata Memorial Centre
Locations
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Tata Memorial Center
Mumbai, Maharashtra, India
Site Status
Tata Memorial Hospital
Mumbai, Maharashtra, India
Site Status
Countries
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India
References
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Zuardi 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.
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Caffarel MM, Moreno-Bueno G, Cerutti C, Palacios J, Guzman M, Mechta-Grigoriou F, Sanchez C. JunD is involved in the antiproliferative effect of Delta9-tetrahydrocannabinol on human breast cancer cells. Oncogene. 2008 Aug 28;27(37):5033-44. doi: 10.1038/onc.2008.145. Epub 2008 May 5.
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Badwe R, Hawaldar R, Parmar V, Nadkarni M, Shet T, Desai S, Gupta S, Jalali R, Vanmali V, Dikshit R, Mittra I. Single-injection depot progesterone before surgery and survival in women with operable breast cancer: a randomized controlled trial. J Clin Oncol. 2011 Jul 20;29(21):2845-51. doi: 10.1200/JCO.2010.33.0738. Epub 2011 Jun 13.
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Manini AF, Yiannoulos G, Bergamaschi MM, Hernandez S, Olmedo R, Barnes AJ, Winkel G, Sinha R, Jutras-Aswad D, Huestis MA, Hurd YL. Safety and pharmacokinetics of oral cannabidiol when administered concomitantly with intravenous fentanyl in humans. J Addict Med. 2015 May-Jun;9(3):204-10. doi: 10.1097/ADM.0000000000000118.
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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.
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Zuardi AW, Shirakawa I, Finkelfarb E, Karniol IG. Action of cannabidiol on the anxiety and other effects produced by delta 9-THC in normal subjects. Psychopharmacology (Berl). 1982;76(3):245-50. doi: 10.1007/BF00432554.
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Crippa JA, Zuardi AW, Garrido GE, Wichert-Ana L, Guarnieri R, Ferrari L, Azevedo-Marques PM, Hallak JE, McGuire PK, Filho Busatto G. Effects of cannabidiol (CBD) on regional cerebral blood flow. Neuropsychopharmacology. 2004 Feb;29(2):417-26. doi: 10.1038/sj.npp.1300340.
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Fusar-Poli P, Crippa JA, Bhattacharyya S, Borgwardt SJ, Allen P, Martin-Santos R, Seal M, Surguladze SA, O'Carrol C, Atakan Z, Zuardi AW, McGuire PK. Distinct effects of delta9-tetrahydrocannabinol and cannabidiol on neural activation during emotional processing. Arch Gen Psychiatry. 2009 Jan;66(1):95-105. doi: 10.1001/archgenpsychiatry.2008.519.
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Bhattacharyya S, Morrison PD, Fusar-Poli P, Martin-Santos R, Borgwardt S, Winton-Brown T, Nosarti C, O' Carroll CM, Seal M, Allen P, Mehta MA, Stone JM, Tunstall N, Giampietro V, Kapur S, Murray RM, Zuardi AW, Crippa JA, Atakan Z, McGuire PK. Opposite effects of delta-9-tetrahydrocannabinol and cannabidiol on human brain function and psychopathology. Neuropsychopharmacology. 2010 Feb;35(3):764-74. doi: 10.1038/npp.2009.184. Epub 2009 Nov 18.
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Schubart CD, Sommer IE, van Gastel WA, Goetgebuer RL, Kahn RS, Boks MP. Cannabis with high cannabidiol content is associated with fewer psychotic experiences. Schizophr Res. 2011 Aug;130(1-3):216-21. doi: 10.1016/j.schres.2011.04.017. Epub 2011 May 17.
Reference Type
BACKGROUND
Other Identifiers
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CTRI/2020/06/020649
Identifier Type: REGISTRY
Identifier Source: secondary_id
TMH Project No. 3386
Identifier Type: -
Identifier Source: org_study_id
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