A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women With BRCA 1/2 Mutations (STICs and STONEs)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 117
- 试验地点
- 17
- 主要终点
- Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test
研究概览
简要总结
While ASA is not a cancer medication, research suggests that taking ASA reduces the probability of getting many types of cancer because of its anti-inflammatory action. Inflammation in the ovaries during ovulation is thought to contribute to the development of ovarian cancer, and, because ASA is an anti-inflammatory medication, it may help to prevent it.
详细描述
The standard or usual treatment for women with a high risk gene mutation, BRCA1 or BRCA2, is to have risk-reducing surgery to remove the fallopian tubes and ovaries (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) after they have decided not to have more children naturally.
Acetylsalicylic Acid (ASA) is a safe, well tolerated drug taken by mouth. ASA has been available for over 100 years and has been used mainly to relieve fever and pain, but also as an anti-inflammatory medication in order to reduce inflammation (swelling).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Previously documented germline BRCA1/2 pathogenic mutation or likely pathogenic variant based on the ACMG 2015 guidelines
- •Risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) scheduled for within 6 months to 2 years after the date of randomization as standard of care, for women who have completed their families
- •ECOG performance status 0 or 1
- •Age ≥ 18 years old
- •Subject is able (i.e. sufficiently literate) and willing to complete the Credibility/Expectancy questionnaire in English or French.
- •Subject consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each subject must sign a consent form prior to enrollment in the trial to document their willingness to participate
- •Subjects must be accessible for treatment and follow up. Subjects randomized on this trial must be treated and followed at the participating centre.
- •In accordance with CCTG policy, protocol treatment is to begin within 2 working days after subject randomization
- •Women of childbearing potential must have agreed to use a highly effective contraceptive method for the duration of the study treatment and for 30 days post last dose of study medication
排除标准
- •Subjects with history of other malignancies, except:
- •adequately treated non-melanoma skin cancer;
- •curatively treated in-situ cancer of the cervix;
- •previously diagnosed (at any point) breast cancer, treated with curative intent; prior chemotherapy is allowed and the last dose must be ≥ 12 months prior to randomization; endocrine therapy for breast cancer is allowed at any time.
- •other solid tumours curatively treated with no evidence of disease for > 5 years.
- •Subjects who have been treated with any PARP-inhibitors (e.g. olaparib) at any time.
- •Subjects with active bleeding or bleeding diathesis.
- •Subjects with active peptic ulcer.
- •Subjects with renal, hepatic or congestive heart failure.
- •Subjects with concurrent use of anti-coagulants and/or anti-platelet agents.
- •Subjects with prior bilateral salpingectomy.
- •Subjects with history of chronic daily use of ASA or NSAIDs.
- •Subjects with intolerance of ASA including subjects with a history of asthma induced by salicylates or substances with a similar action, notably non-steroidal-anti-inflammatory drugs.
- •Ongoing or planned pregnancy.
- •Subjects who are breastfeeding.
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Acetylsalicylic Acid (ASA)
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test
时间窗: 5 years
次要结局
- Acceptance of the ASA intervention from the self-report Credibility/Expectancy Questionnaire(5 years)
- Compliance of taking ASA by serum monitoring(5 years)