JPRN-jRCTs051210039招募中2 期
Randomized Double-Blind Placebo-Controlled Trial on the Effect of Reduced Coenzyme Q10 (CoQ10) for Diarrhea During Radiotherapy for Gynecological Cancer. - PORT Q10
Sasaki Ryohei0 个研究点目标入组 60 人开始时间: 2021年6月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1. Those who are pathologically diagnosed with any of the following gynecologic tumors.
- •Cervical cancer
- •Endometrial cancer
- •Vaginal cancer
- •2. Those who are scheduled for any of the following treatments.
- •Radiotherapy
- •Postoperative radiotherapy
- •3. Women who are 20 years of age or older at the time of obtaining consent.
- •4. Those who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at the time of obtaining consent.
- •5. Those who can fill out the consent form about participation in this clinical research by themselves.
排除标准
- •1. Those who have active multiple cancers.
- •2. Those who have a history or complication of scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis.
- •3. Those who are receiving continuous systemic administration (oral or intravenously) of steroids (prednisolone equivalent 20 mg or more) or immunosuppressive drugs.
- •4. Those who have received radiotherapy for pelvic tumors in the past.
- •5. Those who have taken medication for intestinal disorders such as inflammatory bowel disease.
- •6. Those who are pregnant, may become pregnant, within 28 days after giving birth, or are breastfeeding.
- •7. Those who are allergic to the ingredients of the test drug.
- •8. Those who are taking warfarin.
- •9. Those who take supplements or medicines containing reduced / oxidized CoQ10 as the main ingredient on a daily basis and cannot stop taking them during the entire protocol treatment period.
- •10. Those who have artificial anus.
- •11. Those who are judged by the examiner to be inappropriate for participation in the examination.
研究者
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