Self-administered Artesunate Pessaries for Treatment of Cervical Precancer in Kenya
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- the type, frequency, severity and duration of adverse events
研究概览
简要总结
To investigate the use of self-administered artesunate vaginal pessaries as treatment for cervical precancer in low and middle-income countries (LMIC). The central hypothesis of this study is that self-administered intravaginal Artesunate will be safe, and result in a clinical response among both HIV-positive and HIV-negative women with cervical precancer in LMICs.
详细描述
Despite being preventable, cancer of the cervix is a leading cause of cancer death in Kenya and other low- and middle-income countries (LMIC). Cervical cancer can be prevented if early changes in the cervix, called cervical precancer, are detected through screening, and adequately treated. Cervical precancer treatment includes a surgical procedure called Loop Electrosurgical Excision Procedure (LEEP), which removed the involved area of the cervix.
In countries like Kenya, this LEEP procedure is only available in referral hospitals which have trained consultants, and hence is difficult to access for most women who live in rural areas and away from tertiary facilities. Additionally, the LEEP procedure also increases the chance of a woman not being able to carry a pregnancy to full term, because the cervix is shorter after the procedure. For these reasons, alternative treatments, including self-administered treatments such as Artesunate are being investigated as alternative cervical precancer treatment that can be self-administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cervical lesions referred for excision with CIN2/3 diagnosis on biopsy
- •Weight ≥50 kg
- •Agreement to use contraception (barriers or hormonal) through week 24 of the study if of childbearing age.
- •Ability and willingness to provide informed consent.
排除标准
- •Current pregnancy or breastfeeding status.
- •Current or past history of invasive cervical cancer.
- •History of total hysterectomy.
- •CD4 count less than 200 cells/mm
- •Presence of adenocarcinoma in situ on cervical biopsy
- •Currently receiving systemic chemotherapy or radiation therapy for another cancer
- •Current use of systemic immunosuppressants or steroids (>10 mg of prednisone or equivalent)
- •Have a medical comorbidity that in the opinion of the investigator would interfere with study participation.
- •Prior chemotherapy within 1 month prior to day 1 of study treatment
- •Male at birth
研究组 & 干预措施
Artesunate vaginal inserts/ pessaries
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
干预措施: Artesunate pessary (Drug)
Artesunate vaginal inserts/ pessaries
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
干预措施: Colposcopy (Procedure)
结局指标
主要结局
the type, frequency, severity and duration of adverse events
时间窗: From the first day of the study treatment to week 14 ( 8 weeks after artesunate use)
Safety will be assessed by evaluating the type, frequency, severity, and duration of adverse events (AEs) using the U.S National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0). The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
次要结局
- Adherence(From the first day of the study treatment to week 14 ( 8 weeks after artesunate use))
- Histologic regression(From the first day of the study treatment to week 24)
- Acceptability(At week 8)
- Change in lesion(From the first day of the study treatment to week 24)