Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya

UNC Lineberger Comprehensive Cancer Center

Status and phase: Enrolling; Phase 1

Conditions: Precancerous Conditions; Cervical Precancer; Cervix Neoplasm; Cervix Cancer

Treatments: Procedure: Colposcopy; Drug: Artesunate pessary

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06165614

LCCC2236

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Artesunate vaginal inserts/ pessaries

Experimental group

Description:

Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.

Treatment:

Drug: Artesunate pessary

Procedure: Colposcopy