Is NCT06148038 recruiting in Charleston, SC?

Yes, NCT06148038 is currently recruiting participants at its Charleston, SC location. This breast cancer clinical trial is actively enrolling qualified participants.

How do I join the breast cancer clinical trial in Charleston?

To join this clinical trial in Charleston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Charleston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Breast Cancer Clinical Trial in Charleston, SC

About This Breast Cancer Study in Charleston

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.

Sponsor: Medical University of South Carolina

Who Can Participate

Inclusion Criteria

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.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to registration:

ANC ≥ 1.5 × 109/L

Platelet count ≥ 100 × 109/L

Hemoglobin ≥ 9 g/dL

Albumin ≥ 2.5 g/dL

Bilirubin ≤ 1.5 × the upper limit of normal (ULN)

AST, ALT, and alkaline phosphatase ≤ 3 × ULN

Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 40 mL/min on the basis of measured CrCl from a 24-hour urine collection or Cockcroft-Gault\

glomerular filtration rate estimation: (140-age) × (weight in kg) × (0.85 if female) 72 × (serum creatinine in mg/dL)

The Modification of Diet in Renal Disease (Levey et al. 2006) and the Chronic Kidney Disease Epidemiology Collaboration (Levey et al. 2009) formulas for estimation of glomerular filtration rate are also acceptable.

Self declared ability and capacity to comply with the study and follow-up procedures.

Subjects must be scheduled for surgery no less than 5 days from the planned start of day 1 and no more than 56 days from the planned start of day 1.

Exclusion Criteria

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.

Self reported routine use of recreational or medicinal marijuana products, including over-the-counter CBD oil, Marinol®, Delta-8 THC, or cannabis (defined as \> 4 times over last 30 days) or illicit drug use including opioids, cocaine, amphetamines, PCP, LSD.

Self reported concurrent use of over-the-counter CBD oil, Marinol®, Delta-8 THC, or cannabis.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to CBD or placebo.

Underlying history of epilepsy/ recurrent seizure disorder or unexplained seizure within past 6 months.

Patients with uncontrolled cardiovascular disease defined by myocardial infarction, stroke, or transient ischemic attack, or need for coronary stent placement within past six months.

Patients with a medical history of psychiatric illness or psychiatric symptoms that would prevent them from completing study procedures or would disqualify them from surgical intervention (e.g., untreated schizophrenia, bipolar disorder, or suicide ideation/attempt resulting in psychiatric hospitalization within the last 30 days).

Women who are pregnant or breastfeeding.

Use of blood thinners at the time of registration (warfarin, rivaroxaban, clopidogrel, and apixaban) .

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charleston?

Yes, this clinical trial (NCT06148038) has an active research site in Charleston, SC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Breast Cancer Treatment Options in Charleston, SC

If you're searching for breast cancer treatment options in Charleston, SC, this clinical trial (NCT06148038) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charleston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all breast cancer clinical trials near you to find additional studies recruiting in your area.

Breast Cancer Clinical Trial in Charleston, SC

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