Effects of Tamoxifen in Women With Benign Breast Disease Not Having Any Risks of Developing Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Medical College and Hospital Kolkata
ClinicalTrials.gov Identifier:
NCT00999921
First received: October 21, 2009
Last updated: November 19, 2009
Last verified: November 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Mastodynia
Fibroadenoma
Skin Diseases
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Tamoxifen
Efamol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014