Comparing the effects of N-acetylcysteine administration and placebo on clinical status and metabolic profiles in overweight or obese women with fibrocystic changes of breast

The aim of this study is to determine the effects of N-acetylcysteine administration on clinical status and metabolic profiles in overweight or obese women with fibrocystic changes of breast.

Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive N-acetylcysteine (n=37) or placebo (n=37).

Among overweight or obese women with fibrocystic changes of breast who are referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, 74 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Drugs and placebos are similar. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. intervention period: 12 weeks

Inclusion criteria: Patients aged 18-45 years diagnosed with fibrocystic breast disease, having moderate or severe cyclic mastalgia, BMI ≥ 25. Exclusion criteria: Malignant breast diseases, taking medicines for reducing pain (such as danazol, tamoxifen, bromocriptine) over the past three months, menopause women, pregnant or breastfeeding women, psychological diseases, Unwillingness to cooperate

Intervention group: Tab N-acetylcysteine 600 mg three times a day (Osve Pharmaceutical Co., Tehran, Iran), for 12 weeks orally. Control group: Tab Placebo three times a day (Osve Pharmaceutical Co., Tehran, Iran), for 12 weeks orally.

hs-CRP (primary outcome) and Breast Pain Severity, biomarkers of oxidative stress, parameters of mental health, glucose and lipid metabolism indices (secondary outcomes)

Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 74 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.

Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the general surgery clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of drugs. Drugs and placebos are in the same packaging at the Osve pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of drug. After analyzing the data, pocket codes will be decoded. Participants, investigators or the assessors of the outcomes are unaware of the study groups.