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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Md Tanveer Adil, Medical College and Hospital Kolkata
ClinicalTrials.gov Identifier:
NCT00999921
First received: October 21, 2009
Last updated: April 28, 2015
Last verified: April 2015
  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:
  • Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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


Enrollment: 256
Study Start Date: January 2008
Study Completion Date: January 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Tamoxifen
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.
Other Name: Evening Primrose Oil

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 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
  More Information

Publications:
Responsible Party: Md Tanveer Adil, Resident, 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
Results First Received: November 15, 2010
Last Updated: April 28, 2015
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
Fibroadenoma
Fibrocystic Breast Disease
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Respiratory Tract Diseases
Skin Diseases
Efamol
Tamoxifen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimetabolites
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Bone Density Conservation Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 01, 2015