Effect of Alpha-lipoic Acid on Regression of Low-grade Squamous Intraepithelial Lesions (LSIL)

NCT05485259 | Completed

• 1 other identifier: ALA-SIL-1719
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

Low-grade squamous intraepithelial lesions (LSIL) are premalignant changes on the cervix that can lead to malignant changes, i. e. cervical cancer. Alpha-lipoic acid is a fatty acid that is naturally found in food, and due to its proven antioxidant and anti-inflammatory effects, it is increasingly used as a dietary supplement, most often to alleviate the symptoms of various neuropathic conditions. The purpose of this study was to demonstrate efficiency, safety, and clinical benefit of alpha lipoic acid (ALA) in inducing regression of LSIL. The hypothesis is based on the proven role of oxidative stress and inflammation in formation of LSIL and anti-inflammatory and antioxidative efficiency of ALA. The study was designed as randomized, double-blind, two-arm, placebo-control trial recruiting 100 female patients with diagnosed LSIL. Patients received 600 mg/day of ALA or placebo for 3 months. Progression/regression of LSIL has been defined as primary outcome of the study; inflammation markers and oxidative stress parameters have been defined as secondary outcomes of the study.

Conditions

Low-Grade Squamous Intraepithelial Lesions

Keywords

alpha-lipoic acid; low-grade squamous intraepithelial lesions; LSIL; CIN; cervical intraepithelial neoplasia.

Outcome Measures

Primary Outcomes (1)

• Regression of Low-Grade Squamous Intraepithelial Lesions (LSIL)

  LSIL will be confirmed by cytological screening, colposcopic examination of the cervix and targeted biopsy and histological confirmation of cytological-colposcopic diagnosis at the study baseline and after 3 months the intervention (day 0 and day 90). The findings of cytological screenings will be qualified according to the internationally recognized form "Zagreb 2002". The colposcopic form "Rio de Janeiro-Zagreb 2011" will be used to classify the colposcopic findings. Uterine tissue samples obtained by targeted colposcopic biopsy will be processed by a standard histological method. Assessment of the pathological diagnosis will be done as blindness by a single experienced pathologist at baseline and after the 3 months of intervention. The classification of premalignant and invasive cervical squamous epithelial lesions will be determined according to the WHO Tumour Classification.

  baseline to week 12

Secondary Outcomes (3)

• Change of oxidative stress parameters (serum antioxidant status)

  baseline to week 12

• Change of inflammation markers

  baseline to week 12

• Change of lipid parameters (lipoprotein profile)

  baseline to week 12

Study Arms (2)

DL-alpha lipoic acid

EXPERIMENTAL

600 mg (2x300 mg) of DL-alpha lipoic acid in capsules, per os daily for 3 months

Dietary Supplement: DL-alpha lipoic acid

Placebo

PLACEBO COMPARATOR

600 mg (2\*300 mg) of placebo (rice starch) in capsules, per os, daily for 3 months

Other: placebo (rice starch)

Interventions

DL-alpha lipoic acid DIETARY_SUPPLEMENT

Treatment group recieves 600 mg of DL-alpha lipoic acid daily, per os, for 3 months.

DL-alpha lipoic acid

placebo (rice starch) OTHER

Placebo group recieves 600 mg (2x300 mg) of placebo (rice starch) daily, per os, for 3 months

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• histological confirmation of a low degree of LSIL,
• sexually active women.

You may not qualify if:

• pregnancy
• malignant diseases
• diabetes
• chronic inflammatory diseases
• hysterectomy
• destructive therapy of the cervix
• abortion
• HPV vaccination
• menopause

Sponsors & Collaborators

• University of Zagreb: lead
• University Clinical Center Tuzla: collaborator

Study Sites (2)

University Clinical Center Tuzla

Tuzla, Bosnia and Herzegovina

Location

University of Zagreb

Zagreb, Dep. of Food Chemistry, 10000, Croatia

Location

MeSH Terms

Conditions

Squamous Intraepithelial Lesions; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Dubravka Vitali Čepo, prof

  University of Zagreb, Faculty of Pharmacy and Biochemistry

  PRINCIPAL INVESTIGATOR

• Zinaida Karasalihović, prof

  University Clinical Center Tuzla

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 3, 2022
• Study Start: January 15, 2020
• Primary Completion: January 15, 2022
• Study Completion: June 15, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1); CR (1)