Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06148038

CBD for Breast Cancer Primary Tumors

Led by Medical University of South Carolina · Updated on 2026-04-09

84

Participants Needed

1

Research Sites

144 weeks

Total Duration

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AI-Summary

What this Trial Is About

This is a randomized placebo controlled partially blinded window of opportunity trial. A maximum of 84 patients with invasive breast cancer will be enrolled. Patients will be randomized 2:2:1:1 to either CBD low dose, CBD high dose, matching low dose placebo, or matching high dose placebo using permuted block randomization with random block sizes of 6 or 12. The time window between CBD or placebo initiation and surgery will be between 5 and 56 days.

CONDITIONS

Official Title

CBD for Breast Cancer Primary Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients able to consent for surgery
  • Histologically confirmed invasive breast cancer (stages I, II, or III) with Ki67 proliferation rate ≥ 10%
  • Women 18 years or older at time of consent
  • Women of child-bearing potential must use approved birth control and have a negative pregnancy test before registration
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate blood and organ function based on recent laboratory tests
  • Ability and capacity to comply with study and follow-up procedures
  • Scheduled surgery between 5 and 56 days from planned start of study treatment
Not Eligible

You will not qualify if you...

  • Receiving neoadjuvant chemotherapy or endocrine therapy
  • Known allergy to sesame or compounds similar to CBD or placebo
  • Employment requiring THC drug testing (e.g., South Carolina State employees)
  • Taking drugs metabolized by cytochrome p450 including warfarin, amiodarone, levothyroxine, clobazam, lamotrigine, valproate, prednisolone, hydrocortisone, clarithromycin, itraconazole, erythromycin, fluconazole, clopidogrel, rifampin, sulfamethoxazole, opioids, and certain antiepileptics
  • Routine use of recreational or medicinal marijuana or CBD products (>4 times in last 30 days) or illicit drug use
  • Concurrent use of over-the-counter CBD oil, Marinol®, Delta-8 THC, or cannabis
  • History of epilepsy, recurrent seizures, or unexplained seizures within past 6 months
  • Uncontrolled cardiovascular disease within past 6 months
  • Psychiatric illness or symptoms preventing study participation or surgery
  • Pregnant or breastfeeding women
  • Use of blood thinners at registration (warfarin, rivaroxaban, clopidogrel, apixaban)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

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Research Team

H

HCC Clinical Trials Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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