None listed
Conditions
Brief summary
World-wide cervical cancer is the fourth leading cause of cancer in women. Infection of the uterine cervix with human papillomavirus (HPV) is very common, with a small proportion of those infected progressing to cervical cancer. To date, no treatment of viral infection has been available and only the cell changes brought about by the virus relatively late in the infection are treated by one of the standard surgical methods which remove parts of the cervix affected by the virus. This proof of concept research is to trial application of iodine via a novel delivery device to the upper vaginal vault, ectocervix (outside of the cervix) and endocervical canal (passage that leads from the cervix to the uterus). Women who have persisting HPV despite standard surgical treatment to the cervix are to be recruited and treated as an outpatient procedure, the trial assessing the duration of treatment required for successful eradication of the virus. Should the treatment be found to be effective, women at long term risk of acquiring cervical cancer or adenocarcinoma as a consequence of persistent HPV infection will be offered treatment to eradicate the infection, the HPV vaccine if unvaccinated, then returned to normal follow up as mandated by the accepted guidelines. Health savings will be significant to the WA government by offering a treatment that eradicates an infection linked to potential cancer development (not currently possible) and the necessary follow up the infection entails.
Interventions
5% iodine solution will be applied to the cervix using a delivery device in a single outpatient treatment. Half of the recipients will have active treatment (iodine) and the other half placebo (saline Sodium Chloride injection 0.9% BP (90mg in 10mL) administered via the medical delivery device. The first 20 participants will receive the treatment for 10 minutes, the next 20 participants enrolled will receive the treatment for 15 minutes, and the final 20 participants will receive the treatmen
5% iodine solution will be applied to the cervix using a delivery device in a single outpatient treatment. Half of the recipients will have active treatment (iodine) and the other half placebo (saline Sodium Chloride injection 0.9% BP (90mg in 10mL) administered via the medical delivery device. The first 20 participants will receive the treatment for 10 minutes, the next 20 participants enrolled will receive the treatment for 15 minutes, and the final 20 participants will receive the treatment for 20 minutes. The treatment duration is only increased if a therapeutic response has not been demonstrated at an earlier time interval.. The treatment is to be administered by a gynaecologist in a hospital outpatient clinic. The treating gynaecologist determines the volume of iodine administered based on the size of the cervix, between 10ml and 30ml, The amount of iodine absorbed by each individual patient will depend on the size of the patients cervix and the patients individual diffusion rate for iodine. Assuming a 4-cm2 area saturated to a depth of 0.1mm the amount of iodine would be 0.002g. The delivery device consists of a tube with a balloon to be inserted into the endocervix. The balloon is then inflated to prevent solution entering the uterus and the solution is then delivered to the endocervix. A sponge saturated with additional iodine within a silicon cup is then applied to the outer cervix. Patients will be reminded of follow up appointments.
Sponsors
Jenny McClloskey
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women previously treated for CIN 2 - 3 with persistent HrHPV post treatment. Women Digene Hybrid Capture 2 positive (or other HPV test) Women 25 year or over
Exclusion criteria
Under the age of 25 Male Pregnancy, or planning to become pregnant Current thyroid disease Past history of thyroid disease Family history of thyroid disease History of allergy to iodine History of allergy to rubber History of anaphylaxis Untreated gonorrhoea, or chlamydia Current CIN 2 – 3 on cytology or biopsy HIV infection or other immune deficiency Impaired renal function Autoimmune disorders Systemic or topical steroid therapy IUCD in situ
Outcome results
None listed