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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.


Phase 4
16 Years
N/A
Not Enrolling
Female
Benign Breast Disease, Fibrocystic Disease of Breast, Fibroadenoma, Mastalgia

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Trial Information

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.


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Reduction of Lump Size.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Md. Tanveer Adil

Investigator Role:

Principal Investigator

Investigator Affiliation:

Resident, Department of Surgery, Medical College and Hospital, Kolkata

Authority:

India: Ministry of Health

Study ID:

MSVP-107/08

NCT ID:

NCT00999921

Start Date:

January 2008

Completion Date:

October 2009

Related Keywords:

  • Benign Breast Disease
  • Fibrocystic Disease of Breast
  • Fibroadenoma
  • Mastalgia
  • Fibrocystic Breast Disease
  • Fibroadenoma
  • Mastalgia
  • Breast Diseases
  • Cystic Fibrosis
  • Fibrocystic Breast Disease
  • Fibroadenoma

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