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Completed

NCT Number: NCT00999921

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

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.

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Key information

Conditions

Benign Breast Disease Breast Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Fibroadenoma Fibrocystic Breast Disease Fibrocystic Disease of Breast Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Mastalgia Mastodynia Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Glandular and Epithelial Neurologic Manifestations Pain Pancreatic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Surgery, Medical College, Kolkata

Kolkata, West Bengal, 700073, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tamoxifen

Drug

Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.

Evening Primrose Oil

Drug

Evening Primrose Oil is given at 1000 mg two times daily for 3 months.

Primary outcomes

  1. Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)

    Time frame: 3 months

    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.

  2. Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).

    Time frame: 3 months

    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

Secondary outcomes

  1. Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

Medical College and Hospital Kolkata

Other

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2014
Study completion
2015
First posted
Oct 22, 2009
Registry last updated
May 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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