Open Access Journal of Clinical Trials最新文献

Background: This is a Phase I trial demonstrating safety and tolerability of intravaginal curcumin for future use in women with cervical neoplasia.

Objective: The objective of this study was to assess the safety, tolerability, and pharmacokinetics of intravaginal curcumin in healthy women.

Study design: We conducted a 3+3 dose-escalation Phase I trial in a group of women aged 18-45 years. Thirteen subjects were given one of four doses of curcumin powder (500 mg, 1,000 mg, 1,500 mg, and 2,000 mg) packed in gelatin capsules, which was administered intravaginally daily for 14 days. The primary end point for this study was safety based on severe adverse events regarding laboratory toxicity, clinical findings, and colposcopic abnormalities. We administered an acceptability questionnaire to assess product experience and attributes.

Results: No dose-limiting toxicities (0/13) were experienced (95% confidence interval: 0.0%-22.8%) in this study. The pharmacokinetics data demonstrated that curcumin and curcumin conjugates were not measurable in the serum and negligible in the urine of the study participants. Although 23 adverse events occurred during the course of the trial, all events were grade I based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 and were resolved by the end of the study in an average of 9 days. Fifty-six percent of the adverse events were related to the study drug, which included genital pruritus (23% of subjects), vaginal discharge (100%), vaginal dryness (15%), abnormal prothrombin (23%), and hypokalemia (8%).

Conclusion: Intravaginal curcumin was well tolerated by all subjects and safe. In this Phase I trial, there were no severe adverse events observed at any of the administered dose levels. All adverse events were grade I and did not result in early termination of the study. There was no evidence of systemic absorption or significant local absorption of intravaginally administered curcumin.

Purpose: Older African Americans experience disproportionately higher incidence of morbidity and mortality related to chronic and infectious diseases, yet are significantly underrepresented in clinical research compared to other racial and ethnic groups. This study aimed to understand the extent to which social support, transportation access, and physical impediments function as barriers or facilitators to clinical trial recruitment of older African Americans.

Methods: Participants (N=221) were recruited from six African American churches in Atlanta and surveyed on various influences on clinical trial participation.

Results: Logistic regression models demonstrated that greater transportation mobility (odds ratio [OR]=2.10; p=0.007) and social ability (OR=1.77; p=0.02) were associated with increased intentions of joining a clinical trial, as was greater basic daily living ability (OR=3.25; p=0.03), though only among single participants. Among adults age ≥65 years, those with lower levels of support during personal crises were more likely to join clinical trials (OR=0.57; p=0.04).

Conclusion: To facilitate clinical trial entry, recruitment efforts need to consider the physical limitations of their potential participants, particularly basic physical abilities and disabilities. Crisis support measures may be acting as a proxy for personal health issues among those aged >65 years, who would then be more likely to seek clinical trials for the personal health benefits. Outreach to assisted living homes, hospitals, and other communities is a promising avenue for improved clinical trial recruitment of older African Americans.