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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen | Experimental | 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months |
|
| Evening Primrose Oil | Experimental | 1000 mg daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | 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. | 3 months |
| Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). | 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Md Tanveer Adil | Resident, Department of Surgery, Medical College and Hospital, Kolkata | Principal Investigator |
| 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 Director |
| Utpal De | Professor, Department of Surgery, Medical College and Hospital, Kolkata | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Medical College, Kolkata | Kolkata | West Bengal | 700073 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17509880 | Background | Srivastava A, Mansel RE, Arvind N, Prasad K, Dhar A, Chabra A. Evidence-based management of Mastalgia: a meta-analysis of randomised trials. Breast. 2007 Oct;16(5):503-12. doi: 10.1016/j.breast.2007.03.003. Epub 2007 May 16. | |
| 455247 | Background | Allegra JC, Lippman ME, Green L, Barlock A, Simon R, Thompson EB, Huff KK, Griffin W. Estrogen receptor values in patients with benign breast disease. Cancer. 1979 Jul;44(1):228-31. doi: 10.1002/1097-0142(197907)44:13.0.co;2-0. |
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Postmenopausal women, premenopausal women with pregnancy or other contraindications to tamoxifen, girls less than 15 years, very large lesions, high risk patients with epitheliosis, atypia or atypical hyperplasia or prone to develop malignancy and patients unwilling to undergo treatment were excluded from the study
Premenopausal women with Benign Breast Disease and who belong to non-high risk group for breast cancer were included in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamoxifen | Tamoxifen 10 mg OD from 5th day to 25th day of menstrual cycle for 3 months |
| FG001 | Evening Primrose Oil | Evening Primrose Oil 1000 mg daily for 3 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Evening Primrose Oil | Drug | Evening Primrose Oil is given at 1000 mg two times daily for 3 months. |
|
| 3 months |
| 9543585 | Background | Hurst JL, Mega JF, Hogg JP. Tamoxifen-induced regression of breast cysts. Clin Imaging. 1998 Mar-Apr;22(2):95-8. doi: 10.1016/s0899-7071(97)00076-4. |
| 12591986 | Background | Tan-Chiu E, Wang J, Costantino JP, Paik S, Butch C, Wickerham DL, Fisher B, Wolmark N. Effects of tamoxifen on benign breast disease in women at high risk for breast cancer. J Natl Cancer Inst. 2003 Feb 19;95(4):302-7. doi: 10.1093/jnci/95.4.302. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamoxifen | Tamoxifen was administered at a dose of 10 mg once daily ffrom 5th day to 25 th day of menstrual cycle for 3 months |
| BG001 | Evening Primrose Oil | Evening Primrose Oil was administered at a dose of 1000 mg daily for 3 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | 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. | 102(out of 127) patients receiving Tamoxifen and 99(out of 129) receiving Evening Primrose Oil were assessed for reduction in lump size. The remaining patients had mastalgia with no lump, hence were excluded from this assessment. A 60% or more reduction in lump size after completion of the therapy was considered as a satisfactory response. | Posted | Number | participants | 3 months |
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| Primary | Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). | 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 | 88 patients treated with Tamoxifen and 47 patients treated with Evening Primrose Oil were assessed for Cardiff Breast Pain Score. Patients with fibroadenomas and those with Grade 0 pain at the beginning of therapy were excluded from this analysis. | Posted | Number | participants | 3 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | 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 | 114 patients were identified as having cyclical mastalgia of whom 58 patients(37 fibroadenosis, 3 fibroadenonomas and 18 mastalgias with no lump) received Tamoxifen and 56 (36 fibroadenosis, 3 fibroadenomas and 17 mastalgias with no lump) received Evening Primrose Oil for 3 months. Good response was defined as disappearance of cyclical mastalgia. | Posted | Number | participants | 3 months |
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Adverse Events were assessed at 3 months after completion of therapy, after a 3 month followup and at 6 month followup
Major adverse effect = Menstrual Irregularity,
Minor adverse effects = 1) Hot flushes 2) Nausea and vomiting 3) Mood changes
Presence of major or minor adverse effect at any period of followup was considered as an adverse effect of the total number of participants in the respective arm of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tamoxifen | Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months | 0 | 127 | 82 | 127 | ||
| EG001 | Evening Primrose Oil | Evening Primrose Oil at a dose of 1000 mg once daily for 3 months | 0 | 129 | 0 | 129 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot Flushes | Skin and subcutaneous tissue disorders | Hot Flushes | Non-systematic Assessment | Hot flushes was objectively assessed as a feeling of intense heat with or without sweating and rapid heart beat |
|
| Nausea | Gastrointestinal disorders | Nausea | Non-systematic Assessment | Nausea was noted as a feeling of discomfort in upper abdomen with an involuntary urge to vomit |
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| Mood Changes | Psychiatric disorders | Mood Changes | Non-systematic Assessment | Mood changes were defined as rapid or extreme change in mood |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Md Tanveer Adil | Medical College and Hospital Kolkata | 0091-9830154566 | tanveer.cmc@gmail.com |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D005348 | Fibrocystic Breast Disease |
| D018226 | Fibroadenoma |
| D059373 | Mastodynia |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018225 | Neoplasms, Fibroepithelial |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| C028498 | evening primrose oil |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| >=65 years |
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| Male |
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| Fibroadenosis (less than 60% reduction in size) |
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| Fibroadenoma (total number) |
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| Fibroadenoma (60% or more reduction in size) |
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| Fibroadenoma (less than 60% reduction in size) |
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