Health TrialsbyHealthPanel

CBD for Breast Cancer Primary Tumors

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who are able to consent for surgery.

Histologically confirmed invasive breast cancer (stages I, II, or III) with Ki67 proliferation rate greater than or equal to 10%.

Women 18 years of age or older at time of consent.

Women of child-bearing potential (WOCBP) must agree to use an approved form of birth control and to have a negative pregnancy test result before registration. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes.

Disqualifiers

Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy.

Known allergy to sesame. Please note the study product contains sesame oil.

South Carolina State employees or anyone whose work requires THC drug testing.

Patients taking drugs metabolized by cytochrome p450 including warfarin, amiodarone, levothyroxine, clobazam, lamotrigine, valproate, prednisolone, hydrocortisone, clarithromycin, itraconazole, erythromycin, fluconazole, clopidogrel, rifampin, sulfamethoxazole, any opioids, and antiepileptic medications including carbamazapine, phenytoin, and valproic acid.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CBD Oral

    Drug

    CBD Oral 175mg or 350mg twice daily for 5 days-56 days

  • Control

    Other intervention

    Placebo Control

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: CBD OralExperimental treatment 1 intervention
Group B: Placebo controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

CBD and cell proliferation

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.

Time frame
2 months
2

CBD and apoptosis

To determine whether oral administration of cannabidiol (CBD) causes biological changes related to apoptosis (using Ki67 expression as a marker) in primary tumors of breast cancer patients.

Time frame
2 months

Secondary outcomes

1

Number of participants with treatment-related adverse events as assessed by CTCAE 5.0

To determine adverse event relationship to oral CBD extract in patients with breast cancer.

Time frame
2 months
2

GAD-7 anxiety level scoring at Pre and post CBD administration

To determine whether CBD administered in the period waiting for surgery reduces self-reported anxiety from baseline to time of surgery as measured by the GAD-7 patient reported outcomes scale.

Time frame
2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Source ClinicalTrials.gov
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