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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00999921
Recruitment Status : Completed
First Posted : October 22, 2009
Results First Posted : April 29, 2015
Last Update Posted : May 18, 2015
Information provided by (Responsible Party):
Md Tanveer Adil, Medical College and Hospital Kolkata

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : January 2008
Actual Primary Completion Date : August 2014
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: Tamoxifen
10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
Drug: Tamoxifen
Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.

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

Primary Outcome Measures :
  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 Outcome Measures :
  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

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00999921

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Department of Surgery, Medical College, Kolkata
Kolkata, West Bengal, India, 700073
Sponsors and Collaborators
Medical College and Hospital Kolkata
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Principal Investigator: Md Tanveer Adil Resident, Department of Surgery, Medical College and Hospital, Kolkata
Study Director: Rumana Rahman Resident, Department of Gynaecology and Obstetrics, 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
Study Director: Rupesh Kumar Resident, Department of Surgery, Medical College and Hospital, Kolkata
Study Chair: Utpal De Professor, Department of Surgery, Medical College and Hospital, Kolkata

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Responsible Party: Md Tanveer Adil, Resident, Medical College and Hospital Kolkata Identifier: NCT00999921     History of Changes
Other Study ID Numbers: MSVP-107/08
First Posted: October 22, 2009    Key Record Dates
Results First Posted: April 29, 2015
Last Update Posted: May 18, 2015
Last Verified: April 2015
Keywords provided by Md Tanveer Adil, Medical College and Hospital Kolkata:
Fibrocystic Breast Disease
Additional relevant MeSH terms:
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Cystic Fibrosis
Breast Diseases
Fibrocystic Breast Disease
Skin Diseases
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neurologic Manifestations
Signs and Symptoms
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Evening primrose oil
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents