Benign Breast Disease, Fibroadenoma, Fibrocystic Disease of Breast, Mastalgia
Conditions
Keywords
Fibrocystic Breast Disease, Fibroadenoma, Mastalgia
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.
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.
Interventions
DRUGTamoxifen
Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.
Evening Primrose Oil is given at 1000 mg two times daily for 3 months.
Sponsors
Medical College and Hospital Kolkata
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | 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. |
| Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | 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 |
Countries
India
Participant flow
Recruitment details
Premenopausal women with Benign Breast Disease and who belong to non-high risk group for breast cancer were included in the study
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 127 |
| Evening Primrose Oil Evening Primrose Oil was administered at a dose of 1000 mg daily for 3 months | 129 |
| Total | 256 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 19 |
Baseline characteristics
| Characteristic | Evening Primrose Oil | Tamoxifen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 127 Participants | 124 Participants | 251 Participants |
| Age, Continuous | 25.16 years STANDARD_DEVIATION 3.8 | 25.38 years STANDARD_DEVIATION 4.2 | 25.27 years STANDARD_DEVIATION 4 |
| Region of Enrollment India | 129 participants | 127 participants | 256 participants |
| Sex: Female, Male Female | 129 Participants | 127 Participants | 256 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 82 / 127 | 0 / 129 |
| serious Total, serious adverse events | 0 / 127 | 0 / 129 |
Outcome results
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tamoxifen | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | Fibroadenosis (total number) | 63 participants |
| Tamoxifen | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | Fibroadenosis (60% or more reduction in size) | 54 participants |
| Tamoxifen | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | Fibroadenosis (less than 60% reduction in size) | 9 participants |
| Tamoxifen | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | Fibroadenoma (total number) | 39 participants |
| Tamoxifen | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | Fibroadenoma (60% or more reduction in size) | 4 participants |
| Tamoxifen | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | Fibroadenoma (less than 60% reduction in size) | 35 participants |
| Evening Primrose Oil | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | Fibroadenoma (60% or more reduction in size) | 0 participants |
| Evening Primrose Oil | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | Fibroadenosis (total number) | 61 participants |
| Evening Primrose Oil | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | Fibroadenoma (total number) | 38 participants |
| Evening Primrose Oil | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | Fibroadenosis (60% or more reduction in size) | 14 participants |
| Evening Primrose Oil | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | Fibroadenoma (less than 60% reduction in size) | 38 participants |
| Evening Primrose Oil | Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | Fibroadenosis (less than 60% reduction in size) | 47 participants |
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
Time frame: 3 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tamoxifen | Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). | CBS I (excellent response) | 71 participants |
| Tamoxifen | Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). | CBS II (substantial response) | 13 participants |
| Tamoxifen | Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). | CBS III (poor response) | 3 participants |
| Tamoxifen | Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). | CBS IV (no response) | 1 participants |
| Evening Primrose Oil | Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). | CBS IV (no response) | 11 participants |
| Evening Primrose Oil | Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). | CBS I (excellent response) | 10 participants |
| Evening Primrose Oil | Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). | CBS III (poor response) | 11 participants |
| Evening Primrose Oil | Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). | CBS II (substantial response) | 15 participants |
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
Time frame: 3 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tamoxifen | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Fibroadenosis (good response) | 30 participants |
| Tamoxifen | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Fibroadenoma (poor response) | 0 participants |
| Tamoxifen | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Fibroadenoma (total number) | 3 participants |
| Tamoxifen | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Mastalgia with no lump (total number) | 18 participants |
| Tamoxifen | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Fibroadenosis (poor response) | 7 participants |
| Tamoxifen | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Mastalgia with no lump (good response) | 17 participants |
| Tamoxifen | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Fibroadenoma (good response) | 3 participants |
| Tamoxifen | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Mastalgia with no lump (poor response) | 1 participants |
| Tamoxifen | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Fibroadenosis(total number) | 37 participants |
| Evening Primrose Oil | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Mastalgia with no lump (poor response) | 14 participants |
| Evening Primrose Oil | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Fibroadenosis(total number) | 36 participants |
| Evening Primrose Oil | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Fibroadenosis (good response) | 11 participants |
| Evening Primrose Oil | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Fibroadenosis (poor response) | 25 participants |
| Evening Primrose Oil | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Fibroadenoma (total number) | 3 participants |
| Evening Primrose Oil | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Fibroadenoma (good response) | 1 participants |
| Evening Primrose Oil | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Fibroadenoma (poor response) | 2 participants |
| Evening Primrose Oil | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Mastalgia with no lump (total number) | 17 participants |
| Evening Primrose Oil | Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | Mastalgia with no lump (good response) | 3 participants |