PREMATURE OVARIAN FAILURE IN BREAST CANCER PATIENTS
PREMATURE OVARIAN FAILURE IN BREAST CANCER PATIENTS
批准号:
2667950
负责人:
CHARLES L. SHAPIRO
金额:
$4.29万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1994
资助国家:
美国
项目状态:
已结题
起止时间:
1994-03-01 至 1998-08-31
关键词:
antineoplastics bone density breast neoplasms calcitonin calcium cancer complication chemoprevention clinical trials dietary supplements drug adverse effect estradiol female homeostasis human subject human therapy evaluation longitudinal human study menopause neoplasm /cancer chemotherapy nutrition related tag osteoporosis ovary disorder photon absorptiometry progesterone radioimmunoassay tamoxifen
中文摘要
辅助化疗可降低乳腺癌妇女的死亡率
癌 因为许多乳腺癌患者的生存期延长
在辅助治疗后,
辅助化疗是重要的评估。 卵巢
约70%的绝经前乳腺癌患者会发生绝经失败(绝经)。
接受辅助化疗的癌症患者。 所得
乳腺癌妇女雌激素缺乏与过早绝经
可能会导致骨骼加速流失,
骨折(骨质疏松症)。 为了研究乳腺癌是否
化疗导致卵巢早衰的患者
在特定目标#1中,我们将
前瞻性检查骨密度和生化指标,
绝经前乳腺癌患者骨骼稳态
化疗引起的卵巢早衰 具体目标#2
将测试鼻腔喷雾降钙素,一种骨抑制剂,
吸收,防止这些女性的骨质流失。 绝经前乳腺
将招募具有0-3个腋窝淋巴结转移的癌症患者,
参与这项研究。 100名这样的妇女将接受
月经状态、促卵泡激素的基线评价
(FSH)雌二醇(E2)和孕酮(P),生育史
问卷,活动问卷,抑郁自评
问卷调查,3天膳食评价,定量测量,
腰椎和股骨近端的骨矿物质密度,以及
骨骼稳态的生化指标(血清离子钙,
甲状旁腺激素和骨钙素)。 (DEXA)方法。 后
基线评估将给予辅助化疗。 的
然后在6、12和24个月时重复基线测量。 在
化疗引起卵巢功能衰竭妇女12个月评估
(约70%的参与者)将被随机分配到
一年的降钙素鼻喷雾剂(200 IU/天)加1500 mg口服
每日钙摄入或鼻喷雾安慰剂加每日1500 mg口服
钙摄入量的双盲安慰剂对照试验。 三苯氧胺可以
还防止骨丢失和抑制骨吸收。 具体目标#3
我们将测试三苯氧胺是否能预防乳腺癌患者的骨质流失,
化疗导致卵巢衰竭的患者。 在这
观察性研究42例绝经前乳腺癌患者,
接受辅助化疗和他莫昔芬的腋窝淋巴结转移
将在第6、12和14天接受基线评价和研究评价,
24个月 这些在绝经前乳腺癌女性中进行的前瞻性研究
癌症将提供对化疗自然史的深入了解-
诱发卵巢功能衰竭和骨质流失,以及鼻喷剂的作用
降钙素和他莫昔芬在防止加速骨丢失,
妇女
英文摘要
Adjuvant chemotherapy reduces mortality rates in women with breast
cancer. Because many breast cancer patients have prolonged survival
after adjuvant treatment the long term health effects associated with
adjuvant chemotherapy are important to evaluate. Premature ovarian
failure (menopause) occurs in approximately 70% of premenopausal breast
cancer patients who receive adjuvant chemotherapy. The resulting
estrogen deficiency and premature menopause in women with breast cancer
may result in accelerated loss of bone, and the risk for subsequent
skeletal fractures (osteoporosis). To investigate whether breast cancer
patients who develop chemotherapy-induced premature ovarian failure
experience accelerated bone loss, in Specific Aim #1 we will
prospectively examine bone mineral density and biochemical indices of
skeletal homeostasis in premenopausal breast cancer patients who develop
chemotherapy-induced premature ovarian failure. In Specific Aim #2 we
will test whether nasal spray calcitonin, an inhibitor of bone
resorption, prevents bone loss in these women. Premenopausal breast
cancer patients with 0-3 axillary nodal metastases will be recruited to
participate in this research study. One-hundred such women will undergo
baseline evaluations of menstrual status, follicle-stimulating hormone
(FSH), estradiol (E2), and progesterone, (P), reproductive history
questionnaire, activity questionnaire, self-rating depression
questionnaire, 3-day dietary evaluation, quantitative measurements of
bone mineral density of the lumbar spine and proximal femur, and
biochemical indices of skeletal homeostasis (serum ionized calcium,
parathyroid hormone, and osteocalcin). (DEXA) method. Following the
baseline evaluation adjuvant chemotherapy will be administered. The
baseline measurements will then be repeated at 6, 12, and 24 months. At
the 12 month evaluation women with chemotherapy-induced ovarian failure
(approximately 70% of participants) will be randomly allocated to either
one year of nasal spray calcitonin (200 IU/day) plus 1500 mg of oral
daily calcium intake or nasal spray placebo plus 1500 mg of oral daily
calcium intake in a double-blind placebo-controlled trial. Tamoxifen may
also prevent bone loss and inhibit bone resorption. In Specific Aim #3
we will test whether tamoxifen prevents bone loss in breast cancer
patients with chemotherapy-induced ovarian failure. In this
observational study 42 premenopausal breast cancer patients with 0-3
axillary nodal metastases who receive adjuvant chemotherapy and tamoxifen
will undergo the baseline evaluation and study evaluations at 6, 12, and
24 months. These prospective studies in premenopausal women with breast
cancer will provide insights into the natural history of chemotherapy-
induced ovarian failure and bone loss, and the effects of nasal spray
calcitonin and tamoxifen in preventing the accelerated bone loss in these
women.
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批准号:2376883
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财政年份:1994
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负责人:CHARLES L. SHAPIRO
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PREMATURE OVARIAN FAILURE IN BREAST CANCER PATIENTS
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批准号:2100657
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财政年份:1994
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负责人:CHARLES L. SHAPIRO
-
依托单位:
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-
批准号:2100658
-
项目类别:
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资助金额:$9.01万
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财政年份:1994
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依托单位:
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-
批准号:2100656
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资助金额:$10.19万
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财政年份:1994
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依托单位:
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资助金额:$4.72万
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依托单位:
海外基金