Cervical CancerPhase 2NCT00703196
Folic Acid Clinical Trial for the Prevention of Cervical Cancer
A Phase 2 study testing folic acid in people with Cervical Cancer and Precancerous Condition, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 120 years, women only
- Conditions the study is for
- Cervical Cancer, Precancerous Condition
- What is being tested?
- folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294
About this study
Official title: HPV Clearance by Folic Acid Supplementation (FACT for HPV)
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.
Read the 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.
- Conditions
- Cervical Cancer, Precancerous Condition
- Being tested
- folic acid, placebo
- Keywords
- 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
- Medical subject headings
- Uterine Cervical Neoplasms, Precancerous Conditions, Papillomavirus Infections, Squamous Intraepithelial Lesions, Atypical Squamous Cells of the Cervix, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acidDietary supplement
Given orally once daily
placeboOther
Given orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral folic acid pill once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects. Receives: Dietary Supplement: folic acid |
| Arm II | Placebo comparator | Patients receive oral placebo once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startMar 2007
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Chandrika J. Piyathilake, PhD, MPH, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703196
- Sponsor's protocol ID
- CDR0000579360
- Other IDs
- UAB-F060511015, UAB-IRB0000196
- Status last verified
- Jan 2014
- First submitted
- 20 Jun 2008
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Clearance by Folic Acid Supplementation (FACT for HPV)
- ClinicalTrials.gov ID
- NCT00703196
- Acronym / sponsor ID
- CDR0000579360
- Conditions
- Cervical Cancer, Precancerous Condition
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2007
- Primary completion
- May 2014 (actual)
- First posted
- 23 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Dietary Supplement: folic acidPatients receive oral folic acid pill once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects. |
| Arm II | Placebo comparator | Other: placeboPatients receive oral placebo once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects. |
Who may qualify
- Ages
- 19 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| folic acidGiven orally once daily | Dietary supplement | Arm I |
| placeboGiven orally once daily | Other | Arm II |
Primary outcome
Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandrika J. Piyathilake, PhD, MPH study chair
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing folic acid in people with Cervical Cancer and Precancerous Condition, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2 (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.