Effects of Tamoxifen in Women With Benign Breast Disease Not Having Any Risks of Developing Breast Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Benign Breast Disease Fibrocystic Disease of Breast Fibroadenoma Mastalgia	Drug: Tamoxifen Drug: Evening Primrose Oil	Phase 4

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer cystic fibrosis

MedlinePlus related topics: Breast Diseases Cancer Cystic Fibrosis

Drug Information available for: Tamoxifen Tamoxifen citrate

U.S. FDA Resources

Further study details as provided by Medical College and Hospital Kolkata:

Primary Outcome Measures:

Reduction of Lump Size. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Reduction in Mastalgia (Cardiff Breast Pain Score). [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response of Cyclical Mastalgia. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	256
Study Start Date:	January 2008
Study Completion Date:	October 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

Detailed 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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999921

Locations

India
Department of Surgery, Medical College, Kolkata
Kolkata, West Bengal, India, 700073

Sponsors and Collaborators

Medical College and Hospital Kolkata

Investigators

Principal Investigator:	Md. Tanveer Adil	Resident, Department of Surgery, Medical College and Hospital, Kolkata
Study Chair:	Utpal De	Associate Professor, Department of Surgery, Medical College and Hospital, Kolkata
Study Director:	Rupesh Kumar	Resident, Department of Surgery, Medical College and Hospital, Kolkata
Study Director:	Pradipta Guha	Resident, Department of Medicine, Medical College and Hospital, Kolkata
Study Director:	Soumen Das	Resident, Department of Surgery, Medical College and Hospital, Kolkata
Study Director:	Sudip Sarkar	Resident, Department of Surgery, Medical College and Hospital, Kolkata

More Information

Publications:

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.

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.

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

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.

Responsible Party:	Md. Tanveer Adil, Resident, Department of Surgery, Medical College and Hospital, Kolkata
ClinicalTrials.gov Identifier:	NCT00999921 History of Changes
Other Study ID Numbers:	MSVP-107/08
Study First Received:	October 21, 2009
Last Updated:	November 19, 2009
Health Authority:	India: Ministry of Health

Keywords provided by Medical College and Hospital Kolkata:

Fibrocystic Breast Disease
Fibroadenoma
Mastalgia

Additional relevant MeSH terms:

Breast Diseases
Cystic Fibrosis
Fibrocystic Breast Disease
Fibroadenoma
Skin Diseases
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Tamoxifen
Efamol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013