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临床试验/EUCTR2015-005147-14-IT
EUCTR2015-005147-14-IT进行中(未招募)1 期

The effect of low dietary glycemic index, excercise and vitamin D on breast cancer recurrence in women - DEDiCa

ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE0 个研究点目标入组 506 人开始时间: 2020年10月6日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
506

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • 1. Women with primary diagnosis of histologically confirmed breast cancer (stages I-III, Table 1), without metastasis, within 12 months from histological diagnosis.
  • 2. Age = 30 and < 75 years.
  • 3. Patients who are able to comprehend and are willing to sign the consent form and are able to adhere to the protocol including scheduled clinic visits and assigned treatment. The consent form has to be obtained before any protocol procedure.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 400
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 106

排除标准

  • 1.Patients who do not possess the inclusion criteria for this study.
  • 2.Patients with sarcoidosis or other granulomatous diseases or with hypercalcemia (Ca>11mg/dL)
  • 3.Patients with any previous or with current concomitant other malignant cancer
  • 4.Patients with diagnosis of AIDS
  • 5.Pregnant or lactating women
  • 6.Patients with severe renal insufficiency
  • 7.Patients with kidney stones (nephrocalcinnosis or nephrolithiasis)
  • 8.Patients participating in other lifestyle clinical trials

研究者

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