A clinical trial to study the effects of two drugs, Centchroman versus Tamoxifen in patients with breast pain and non-cancerous breast lumps.
- Conditions
- Health Condition 1: null- Breast pain and breast lump that are FNAC or biopsy proven benign breast lump less than 2.5cm.
- Registration Number
- CTRI/2016/05/006905
- Lead Sponsor
- Intra Mural Grant from All India Institute of Medical Sciences New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 200
1. All women (18years and older) with mastalgia with VAS score > 3 lasting for more than 3 months
2.Clinical, radiographic and histological (breast lump / sonological visible lesion) diagnosis of benign breast disease.
3.Benign breast disease such as adenosis, cyst, duct ectasia, fibrocystic disease, fibro-adenoma ( < 3cm), fibrosis, hyperplasia and metaplasia.
4.Normal liver function test, complete blood count, renal function test.
5.No deep vein thrombosis or No pulmonary embolus or No cerebral vascular accident, transient ischemic attack, atrial fibrillation, or uncontrolled hypertension
6.No history of prior malignancy within the past 5 years
7.No clinical depression, psychiatric condition, or addictive disorder
1.Age less than 18 years or more than 65 years
2.Benign breast lesions which require surgery for Cosmesis.
3.Fibro adenoma more than or equal to 2.5 cm.
4.Acute Inflammatory breast lesions which are amenable to antibiotic therapy or surgical drainage
5.Past history of breast carcinoma or family history of breast carcinoma
6.Patients with polycystic ovarian diseases and cervical hyperplasia / chronic cervicitis
7.Oligomenorrhoea and irregular menstrual bleeding
8.Tuberculosis, renal disease and hypersensitivity to centchroman or tamoxifen
9.Pregnancy or planning to conceive.
10.Lactation of initial 6 months duration
11.Patients unwilling to undergo treatment or not willing to consent for the study
12.High risk breast lesions like epitheliosis, atypia or atypical hyperplasia or evidence of malignancy on histopathology or susceptible lesions prone to develop malignancy on ultrasonography
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method is to determine the efficacy of regimens in the participants in each group <br/ ><br>1 Reduction of mastalgia cyclical and non-cyclical or heaviness discomfort by 80 per cent reduction of pain to less than or equal to 3 on VAS <br/ ><br>2 Reduction in Lump Size or nodularity by 50 percent documented by Ultrasonography of the breast for quantitative analysis of FNAC or biopsy proven non-malignant or benign lesion of breast <br/ ><br>Timepoint: 4 weeks <br/ ><br>8 weeks <br/ ><br>12 weeks <br/ ><br>24 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Tolerability means the toxic effects or side effect or Adverse drug reactions of regimens in the participants in each group <br/ ><br>2. Cost effectiveness means saving of time and money by reduction in Number of OPD visits or reduction in cost or saving of time <br/ ><br>Timepoint: 24 Weeks