Clinical trial NCT06165614: Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya
Official title: Self-administered Artesunate Pessaries for Treatment of Cervical Precancer in Kenya
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cervix Cancer
Cervix Neoplasm
Precancerous Conditions
Cervical Precancer
Keywords: vaginal pessaries
artesunate
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2023-12-11
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Cervical lesions referred for excision with CIN2/3 diagnosis on biopsy
2. Weight ≥50 kg
3. Agreement to use contraception (barriers or hormonal) through week 24 of the study if of childbearing age.
4. Ability and willingness to provide informed consent.

Exclusion Criteria:

1. Current pregnancy or breastfeeding status.
2. Current or past history of invasive cervical cancer.
3. History of total hysterectomy.
4. CD4 count less than 200 cells/mm3.
5. Presence of adenocarcinoma in situ on cervical biopsy
6. Currently receiving systemic chemotherapy or radiation therapy for another cancer
7. Current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent)
8. Have a medical comorbidity that in the opinion of the investigator would interfere with study participation.
9. Prior chemotherapy within 1 month prior to day 1 of study treatment
10. Male at birth

Primary outcomes:
measure: the type, frequency, severity and duration of adverse events
timeFrame: From the first day of the study treatment to week 14 ( 8 weeks after artesunate use)
Secondary outcomes:
measure: Adherence
timeFrame: From the first day of the study treatment to week 14 ( 8 weeks after artesunate use)
measure: Change in lesion
timeFrame: From the first day of the study treatment to week 24
measure: Histologic regression
timeFrame: From the first day of the study treatment to week 24
measure: Acceptability
timeFrame: At week 8
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Lumumba Sub-County Hospital
Study officials:
affiliation: Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
name: Chemtai Mungo, MD, MPH, FACOG
role: PRINCIPAL_INVESTIGATOR
References: