Folic Acid Clinical Trial for the Prevention of Cervical Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00703196
First received: June 20, 2008
Last updated: August 19, 2014
Last verified: January 2014
  Purpose

RATIONALE: Supplements, such as folic acid, may stop or delay the development of cervical cancer in women infected with human papillomavirus.

PURPOSE: This phase II trial is studying how well folic acid supplements work in preventing cancer in women infected with human papillomavirus.


Condition Intervention Phase
Cervical Cancer
Precancerous Condition
Dietary Supplement: folic acid
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: HPV Clearance by Folic Acid Supplementation (FACT for HPV)

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2 [ Time Frame: One Year ] [ Designated as safety issue: No ]

Enrollment: 368
Study Start Date: March 2007
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral folic acid pill once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.
Dietary Supplement: folic acid
Given orally once daily
Placebo Comparator: Arm II
Patients receive oral placebo once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.
Other: placebo
Given orally once daily

Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the effects of folic acid supplementation on clearance of human papilloma virus (HPV) 16 and other specific types of HR-HPV and on prevention of the progression of ≤ cervical intraepithelial neoplasia (CIN) 1 lesions (not true preneoplastic lesions) to CIN ≥ 2 (true neoplastic lesions) by conducting a 12-month double-blind randomized placebo-controlled trial with 5 mg of folic acid/day.

Secondary

  • Evaluate whether the clearance of HPV 16 and other specific HR-HPV types and the progression of cervical lesions (≤ CIN 1 to CIN ≥ 2) is modified by lower levels of circulating and/or cervical cell folate, presence of micronuclei or global DNA hypomethylation in cervical cells, presence of integrated vs episomal HPV 16, or a high HPV 16 viral load in cervical cells at the enrollment.

OUTLINE: This is a single center study. Patients are stratified according to multivitamin use (yes vs no) and smoking status (smoker vs nonsmoker). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral folic acid pill once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.
  • Arm II: Patients receive oral placebo once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.

All patients complete a diet, physical activity, and a risk factor questionnaire at the enrollment visit (0-month) and at 4, 8, and 12 month visits (a total of 4 visits). Fasting blood samples for assessing circulating concentrations of micronutrients (folate, vitamins B12, A, E, C, and total carotenes) and exfoliated cervical cell samples for assessing HPV are collected at all 4 visits. Anthropometric measures are taken at all study visits. A colposcopically directed biopsy is taken at the 0-month visit and at the 12-month visit to assess the histological diagnoses of cervical lesions.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Received care at the Health Departments in Alabama and with an abnormal pap result, including any of the following:

    • Atypical squamous cells of undetermined significance (ASCUS)
    • ASCUS, cannot exclude high-grade lesion (ASCUS-H)
    • Low-grade squamous intraepithelial lesion
    • High-grade squamous intraepithelial lesion
  • Referred to University of Alabama at Birmingham (UAB) Highlands Clinic for further colposcopic examination by Ob/Gyn physicians
  • Tested positive for human papilloma virus (HPV) 16 and diagnosed with ≤ cervical intraepithelial neoplasia (CIN) 1 lesions at the 0-month visit

    • With or without concurrent infections with other HR (High Risk) HPV types (HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68)
  • Not diagnosed with true preneoplastic lesions of the cervix based on a colposcopically directed biopsy

PATIENT CHARACTERISTICS:

  • Not pregnant
  • Willing to take study pills, keep scheduled follow-up study visits, or communicate with study personnel about changes in contact information during the study period
  • No prior diagnosis or treatment for colon polyps or breast lumps

PRIOR CONCURRENT THERAPY:

  • No prior treatment for cervical cancer or precancerous condition
  • No prior surgeries involving the cervix
  • No concurrent antifolate medications such as methotrexate, sulfasalazine or phenytoin
  • No concurrent or planned consumption of 400 μg or more of a folic acid supplement on a regular basis
  • Not involved in any other clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703196

Locations
United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Study Chair: Chandrika J. Piyathilake, PhD, MPH University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00703196     History of Changes
Other Study ID Numbers: CDR0000579360, UAB-F060511015, UAB-IRB0000196
Study First Received: June 20, 2008
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
cervical cancer
human papilloma virus infection
low-grade squamous intraepithelial lesion
high-grade squamous intraepithelial lesion
atypical squamous cells of undetermined significance
cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Neoplasms
Precancerous Conditions
Genital Diseases, Female
Uterine Diseases
Folic Acid
Vitamin B Complex
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on October 20, 2014