Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer

Benign Breast Disease Clinical Trial

Official title:

A Single Blinded Randomized Controlled Trial of the Comparative Effects of Tamoxifen and Evening Primrose Oil in Premenopausal Non-high Risk Patients With Benign Breast Disease With Respect to the Estrogen Receptor Status.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999921
• Other study ID #: MSVP-107/08
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2009
• Last updated: April 28, 2015
• Start date: January 2008
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Medical College and Hospital Kolkata
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the efficacy and relapse rate of low dose, short duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with respect to etiology and estrogen receptor status and to realize its side-effects and cost of therapy.

To do a comparative analysis of the results with evening primrose oil which is one of the first line management in benign breast disease.

Description:

Benign breast disease is frequently encountered in female patients, a significant proportion of who are premenopausal women. Established methods of treatment do not yield significant results. This is not only a social burden but also entails high economic cost. As such the quality of life of these patients is a matter of concern for both the patients and their families and to attending physicians. Reported effects of tamoxifen on benign breast disease in premenopausal non high risk patients are scarce. Moreover published data has not yet revealed association of estrogen receptors in different benign breast lesions.The variability of response and its relation with estrogen receptor status is still a field of active investigation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Clinical, Radiographic and Histological diagnosis of Benign Breast Disease.

• Benign Breast disease amenable to hormonal therapy.

Exclusion Criteria:

• Postmenopausal women.

• Premenopausal women with pregnancy or other contraindications to tamoxifen.

• Girls less than 16 years.

• Very large lesions which require surgery for cosmesis.

• High risk breast lesions like epitheliosis, atypia or atypical hyperplasia on histopathology or susceptible lesions prone to develop malignancy.

• Lesions like duct ectasia where hormone therapy is not likely to be of benefit.

• Inflammatory lesions which are amenable to antibiotic therapy or surgical drainage for treatment.

• Patients unwilling to undergo treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Breast Disease
• Breast Diseases
• Cystic Fibrosis
• Fibroadenoma
• Fibrocystic Disease of Breast
• Mastalgia

Intervention

Drug:
• Tamoxifen
Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.
• Evening Primrose Oil
Evening Primrose Oil is given at 1000 mg two times daily for 3 months.

Locations

Country	Name	City	State
India	Department of Surgery, Medical College, Kolkata	Kolkata	West Bengal

Sponsors (1)

Lead Sponsor	Collaborator
Medical College and Hospital Kolkata

Country where clinical trial is conducted

India, 

References & Publications (4)

Allegra JC, Lippman ME, Green L, Barlock A, Simon R, Thompson EB, Huff KK, Griffin W. Estrogen receptor values in patients with benign breast disease. Cancer. 1979 Jul;44(1):228-31. — View Citation

Hurst JL, Mega JF, Hogg JP. Tamoxifen-induced regression of breast cysts. Clin Imaging. 1998 Mar-Apr;22(2):95-8. — View Citation

Srivastava A, Mansel RE, Arvind N, Prasad K, Dhar A, Chabra A. Evidence-based management of Mastalgia: a meta-analysis of randomised trials. Breast. 2007 Oct;16(5):503-12. Epub 2007 May 16. — View Citation

Tan-Chiu E, Wang J, Costantino JP, Paik S, Butch C, Wickerham DL, Fisher B, Wolmark N. Effects of tamoxifen on benign breast disease in women at high risk for breast cancer. J Natl Cancer Inst. 2003 Feb 19;95(4):302-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)	Ultrasonography of the breast was used to ascertain the lump size at the beginning of therapy and a repeat Ultrasonography of breast was done after 3 months at the end of the proposed therapy to record the posttreatment lump size by the same operator. The difference between the two findings were recorded and noted and a 60% or more reduction in the size of the lump was considered as a satisfactory response.	3 months	No
Primary	Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).	All patients were categorized as Grade 0 for no pain, grade 1 for mild pain, grade 2 for moderate pain, Grade 3 for severe pain. Therapeutic response to mastalgia was expressed in terms of Cardiff Breast Pain Score (CBS) where CBS I = excellent response with no pain, CBS II = substantial response, CBS III = poor response and CBS IV = no response	3 months	No
Secondary	Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)	All patients who had an increase in breast pain in the "perimenstrual period" were designated as having cyclical mastalgia. Response was assessed following treatment in terms of either persistence of cyclical mastalgia after 3 months of treatment or disappearance of cyclical mastalgia	3 months	No