EUCTR2020-004442-11-DK进行中（未招募）1 期
The effect of Melatonin in patients with Low Anterior Resection Syndrome - MELLARS trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
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
- All
入选标准
- •1. Patients should have major LARS (LARS score >29)
- •2. Patients should have undergone bowel continuity restoring surgery between the last 3 to 24 months
- •3. Participants should be 18 years or older.
- •4. Participants must sign an informed consent form
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Known allergic reaction to melatonin
- •2. Dementia as determined by mini mental state examination score (MMSE) < 24
- •3. Participation in another pharmacological intervention trial at the point of inclusion
- •4. Completed any adjuvant oncological treatment within the last three months
- •5. Ongoing oncological treatment
- •6. Rotor or Dubin-Johnson syndrome, epilepsy, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), Parkinson’s disease, spinal cord injury, and multiple sclerosis
- •7. Severe liver disease defined as transaminases above 3 times the normal levels, and severe kidney disease defined as eGFR below 40 ml/min
- •8. Daily ongoing hypnotic treatment
- •9. Pre-existing medical sleep disorder diagnosed before the diagnosis of rectal cancer (i.e sleep apnea, restless legs, narcolepsy.)
- •10. Work involving nightshifts
- •11. Daily alcohol consumption above 5 units of alcohol (1 unit = 12 g alcohol)
- •12. Predictable poor compliance (due to pre-existing psychiatric disease, dementia or not able to read or speak sufficient Danish)
- •13. Pregnant or breastfeeding
- •14. Severe, life-threatening medical condition, that implies that the patient cannot participate in the study course. (e.g. metastatic disease, local recurrence, stroke, AMI)
- •15. Females not in menopause (defined as no menstruation during the last 12 months) should not be pregnant. Furthermore, reproductive females should use a secure birth control (intrauterine devices, hormonal contraceptives including – oral pills, patches, vaginal rings and injections) during the entire period of the trial
研究者
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