Plain English Summary
Background and study aims
Cervical carcinoma (cervical cancer) is one of the major public health problems in the world; in Mexico it is the second leading cause of death in women. Almost all cases of cervical cancer are caused by the human papilloma virus (HPV). It is a very common virus that can be passed on by sexual contact. It usually takes many years to develop. Before the cancer actually develops, the cells of the cervix often show changes known as cervical intraepithelial neoplasia (CIN). Patients with CIN1 cells are unlikely to develop cancer and the abnormal cells will often disappear without treatment. However, they can also progress to CIN2 or CIN3, at which point, the risk of developing cervical cancer increases. Removing the cells at these stages is usually recommended. Some 50% of adolescents and young adults can be infected with HPV within the first few years of starting a sex life. 90-95% of infections are resolved thanks to the immune system. However, in certain cases some infected women become long-term infected (viral persistence) and suffer from chronic cervical inflammation, which increases the risk of cervical intraepithelial neoplasia and cancer. It is, therefore, very important to provide timely treatment for women with precancerous lesions (CIN), including the use of immunotherapies that enable the proper functioning of the immune system against viral persistence. Dialyzable leukocyte extract (DLE) can activate the immune response against infections or neoplasias. The main objective of this work was to document the effect of DLE immunotherapy on the immune response of patients with cervical lesions.
Who can participate?
Women diagnosed with CIN1.
What does the study involve?
First of all, participants undergo a medical history, assessment of clinical symptoms, cervical cytology, colposcopy and cervical biopsy. They are then randomly allocated to one of two groups. Those in group 1 are given DLE for one month. Those in group 2 are given a placebo (dummy treatment) for one month. After the months treatment is complete, each participant undergoes another assessment of their clinical symptoms, a colposcopy and a cervical biopsy.
What are the possible benefits and risks of participating?
Possible benefits to participating in this study include almost total remission of the clinical symptoms particularly those associated with cervicitis (inflammation of the cervix) and abdominal pain, remission of cervical lesions and free treatment.
Where is the study run from?
The National Polytechnic Institute, Clinic of Gynecology and Obstetrics, Hospital General de Milpa Alta, Center for Research and Advanced Studies and Laboratory Farmainmune (Mexico City, Mexico)
When is the study starting and how long is it expected to run for?
January 2013 to December 2013
Who is funding the study?
National Council of Science and Technology, Mexico
Who is the main contact?
Dr Guillermo Perez Ishiwara
ishiwaramx@yahoo.com.mx
Trial website
Contact information
Type
Scientific
Primary contact
Dr Guillermo Perez Ishiwara
ORCID ID
http://orcid.org/0000-0001-9368-3717
Contact details
Escuela Nacional de Medicina y Homeopatía-IPN
239 Guillermo Massieu Helguera Street
La Escalera
Mexico City
07320
Mexico
+52 (01) 5729 6300 Ext. 55534.
ishiwaramx@yahoo.com.mx
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The dialyzable leukocyte extract activates cervical innate immunity in HPV-infected patients with CIN 1
Acronym
Study hypothesis
If the dialyzable leukocyte extract (DLE) has an anti-inflammatory effect, the DLE treatment of HPV infected patients with preneoplasic lesions would regulate the cervical immune response, modifying the clinical and histopathological signs of the disease.
Ethics approval
Ethics Committee of the National School of Medicine and Homeopathy from National Polytechnic Institute (Mexico), 11/01/2015, ref: 0152013
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Low-grade cervical intraepithelial neoplasia (CIN-1)
Intervention
A total of 54 Mexican women patients with cervical cytological diagnosis of CIN 1 were included in this study. After signing the consent form, patients were evaluated by clinical signs and symptoms. Then, colposcopy and biopsy were taken to confirm the Intraepithelial Low-Grade Lesion (CIN 1). Patients were randomly divided into two groups: placebo group and DLE-treatment group. Each group was treated in a double blind random way using 3 units of placebo or DLE per week, during one month. Then, patients were clinically evaluated and explored again by colposcopy. Cervical samples were taking for both, histopathological and immuno-histochemical assays. HPV genotyping were done from biopsy samples obtained before treatment.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
1. The colposcopical characteristics of cervical lesions using the iodine test, qualitatively measuring the cervical localization and extension of the lesions
2. Evaluation of clinic signs and symptoms considering the Mexican NOM-014-SSA2-1994 for the prevention, detection, diagnosis, control and treatment of Cu CA
Measured before and after one month of treatment.
Secondary outcome measures
1. Histopathological characterization of biopsies lesions
2. Immunohistochemical evaluation of immunological markers related to innate immune response
Measured before and after one month of treatment.
Overall trial start date
01/01/2013
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women between 20 and 60 years old with cytological CIN 1 diagnosis.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
54
Participant exclusion criteria
1. Women under 20 and over 60 years old
2.Pregnant.
3. Diabetic
4. With autoimmune or infectious diseases
5. Patients with cervicitis under treatment
6. Diagnosed with cervical cancer in situ or invasive
7. With pre-malignant CIN III lesions whose biopsy shows positive margins
8. With pre-malignant lesions of cervical cancer that have been treated with invasive methods
Recruitment start date
02/01/2013
Recruitment end date
20/12/2013
Locations
Countries of recruitment
Mexico
Trial participating centre
National Polytechnic Institute (Instituto Politécnico Nacional)
Guillermo Massieu H. 239
Colonia La Escalera
Gustavo A. Madero
Mexico City
07320
Mexico
Trial participating centre
Clinic of Gynecology and Obstetrics
Carlota Armero 5 B -20
Colonia CTM Culhuacan
Delegacion Coyoacán
Mexico City
04480
Mexico
Trial participating centre
Hospital General de Milpa Alta
Blvd. José López Portillo 386
Colonia Santa Cruz Milpa Alta
Mexico City
12000
Mexico
Trial participating centre
Center for Research and Advanced Studies
Department of Genetics and Molecular Biology
Av. Instituto Politécnico Nacional 2508
Colonia San Pedro Zacatenco
Mexico City
07360
Mexico
Trial participating centre
Laboratory Farmainmune
Naranjos 129
Colonia Petrolera
Delegacion Azacapotzalco
Mexico City
02480
Mexico
Sponsor information
Organisation
National School of Medicine and Homeopathy from National Polytechnic Institute (Mexico).
Sponsor details
Escuela Nacional de Medicina y Homeopatía-IPN
239 Guillermo Massieu Helguera Street
La Escalera
Mexico City
07320
Mexico
+52 (01) 5729 6300 Ext. 55534.
vejimenez_sanchez@hotmail.com
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Consejo Nacional de Ciencia y Tecnología
Alternative name(s)
National Council of Science and Technology, Mexico, CONACYT
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Mexico
Results and Publications
Publication and dissemination plan
The relevance of this work is to report the immunological and histopathological findings related to the reduction of cervical lesions as well as the remission of inflammation due the administration of DLE. We plan to publish it as soon as possible in the Journal of Immunology Research.
Intention to publish date
31/03/2016
Participant level data
Available on request
Basic results (scientific)
Publication list