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NCT06148038 · ClinicalTrials.gov registry record · Phase 1
CBD for Breast Cancer Primary Tumors
A Phase 1 study, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT06148038: Recruiting Phase 1 study, sponsored by Medical University of South Carolina.
NCT06148038 is a Phase 1 study that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06148038, a Phase 1 study, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
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.
Primary Outcome
To determine whether oral administration of cannabidiol (CBD) causes biological changes related to cell proliferation (using Ki67 expression as a marker) in primary tumors of breast cancer patients.
Interventions
- OTHER Control
- DRUG CBD Oral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2026-09-15 |
| Est. Completion | 2029-03-25 |
| Phase | Phase 1 |
What NCT06148038 shows while recruiting
NCT06148038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT06148038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06148038 about?
NCT06148038 is a clinical study titled "CBD for Breast Cancer Primary Tumors". 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 perm...
What is the current status of trial NCT06148038?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2026-09-15. Estimated completion is 2029-03-25.
What interventions are being tested in trial NCT06148038?
The interventions under investigation include: Control (OTHER), CBD Oral (DRUG).
Who is sponsoring clinical trial NCT06148038?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06148038's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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