Cryotherapy for Human Papillomavirus Clearance in Biopsy-confirmed Cervical Low-grade Squamous Intraepithelial Lesions

NCT00566579 | Terminated Results

• 1 other identifier: HE500830
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Persistent human papillomavirus (HPV) infections is the single necessary cause of cervical cancer. Cervical cancer is still the major health problem in the developing countries. It has been the first rank women's cancer in Thailand for many decades. Approximately 10-20% of Thai women have the high-risk HPV (HR-HPV) infections in their cervices. This will frequently lead to low-grade squamous intraepithelial lesions (LSILs) (10%), high-grade squamous intraepithelial lesions (HSILs) (0.8%), and finally, cervical cancers (0.16%) within 10-20 years. The treatment options for LSILs are either observation or ablative surgery. However, in our institute, cryotherapy, which is the one of ablative surgery, is more frequently used to comfort our women. It is not only effective but safe with only minimal side effects; watery leukorrhea for 2-4 weeks, and local cervical infection not more than 1%. Contraindication to this procedure are active cervical infection, lesion of 2 mm-larger than probe, lesion inside cervical os and suspected cervical cancer. Additionally, in developing countries such as Thailand, this treatment is safe, acceptable, feasible and effective. Patients with LSILs could also have this treatment in some rural area from the 10-days trained nurses. Fortunately, recent reports showed that cryotherapy has abilities not only in clearing LSILs but also clearing the HPV infections, its necessary cause. However, there are no randomized controlled trial compared its clearing ability between observation and cryotherapy. Therefore, a randomized controlled trial is needed to demonstrate that. Findings from this trial will contribute enormously to older women who already get infected by HPV. Aside from preventing cervical cancer in treated woman, cryotherapy could also give her relief from worrying about having a time-bomb like HPV infection in her cervix.

Conditions

Human Papillomavirus Clearance at 12 Months

Keywords

Human papillomavirus; Clearance; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Human Papillomavirus Clearance

  At 12 months after treatment, a patient with negative results for HPV testing of previous types was considered as a clearance.

  12 months

Study Arms (2)

A

EXPERIMENTAL

Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.

Procedure: Cryotherapy

B

NO INTERVENTION

Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.

Interventions

Cryotherapy PROCEDURE

Double freezing technique

Also known as: Cryosurgery

A

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-confirmed LSIL patients
• Age more than 30 years-old
• Baseline HPV testing is positive.
• Be able to give their informed consent to this study.

You may not qualify if:

• Having active cervical infection
• Having lesion of 2 mm-larger than probe
• Having lesion inside cervical os
• Having suspected cervical cancer lesion

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Muang, Changwat Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• Chumworathayi B, Thinkhamrop J, Blumenthal PD, Thinkhamrop B, Pientong C, Ekalaksananan T. Cryotherapy for HPV clearance in women with biopsy-confirmed cervical low-grade squamous intraepithelial lesions. Int J Gynaecol Obstet. 2010 Feb;108(2):119-22. doi: 10.1016/j.ijgo.2009.09.012. Epub 2009 Nov 4.

  PMID: 19892345 DERIVED

Related Links

• The Thailand Research Fund's website

MeSH Terms

Interventions

Cryotherapy; Cryosurgery

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Bandit Chumworathayi
• Organization: Department of OBGYN, Faculty of Medicine, Khon Kaen University, 40002, THAILAND

bunchu@kku.ac.th

66818733327

Study Officials

• Bandit Chumworathayi, MD

  Gynecologic Oncology Division, OBGYN Department, Faculty of Medicine, Khon Kaen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 3, 2007
• Study Start: December 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 10, 2010
• Results First Posted: August 2, 2010

Record last verified: 2007-12

Locations

TH (1)