The Effect of Melatonin in Patients With Low Anterior Resection Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Low Anterior Resection Syndrome Score
研究概览
简要总结
The primary objective of the study is to investigate whether treatment with melatonin has an alleviating effect on Low Anterior Resection Syndrome (LARS) symptoms. Secondarily, the effect of the treatment on bowel movements, other patient reported symptoms, quality of life, depression, anxiety, sleep disturbances, motilin levels, and microscopic changes in rectal mucosa will be investigated.
详细描述
This trial which will be conducted in two phases.
The first part of the study will be conducted as an internal feasibility test. Three patients with major LARS will be included. Patients will be recruited from the Department of Surgery, Zealand University Hospital. These patients will not be randomized nor blinded. They will receive a 4-week treatment with 25 mg melatonin and will undergo the same questionnaires and tests before and after treatment as in the randomized clinical trial. The preliminary results from the internal feasibility test will allow us to assess potential difficulties related to the administration or design, which then will be able to be corrected before the randomization part is initiated.
The second part of the will be conducted as a randomized, blinded, placebo-controlled, crossover study and will be testing whether treatment with melatonin has an alleviating effect on Low Anterior Resection Syndrome (LARS) symptoms.
Patients will be randomized to receive 4 weeks of treatment with melatonin, followed by a 4 week wash out period, and then 4 weeks of treatment with placebo (M-P) or 4 weeks of treatment with placebo, followed by a 4 week wash out period, and then 4 weeks of treatment with melatonin (P-M). Both participants and investigators will be blinded.
Patients will be given questionnaires before and after each treatment period to assess outcomes. Blood samples and rectal biopsies will be taken after each treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should have major LARS (LARS score >29).
- •Patients should have undergone bowel continuity restoring surgery between the last 3 to 24 months.
- •Participants should be 18 years or older.
- •Participants must sign an informed consent form.
排除标准
- •Known allergic reaction to melatonin.
- •Dementia as determined by mini mental state examination score (MMSE) <
- •Participation in another pharmacological intervention trial at the point of inclusion.
- •Completed any adjuvant oncological treatment within the last three months.
- •Ongoing oncological treatment.
- •Rotor or Dubin-Johnson syndrome, epilepsy, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), Parkinson's disease, spinal cord injury and multiple sclerosis.
- •Severe liver disease defined as transaminases above 3 times the normal levels, and severe kidney disease defined as eGFR below 40 ml/min.
- •Daily ongoing hypnotic treatment.
- •Pre-existing medical sleep disorder diagnosed before the diagnosis of rectal cancer (i.e sleep apnea, restless legs, narcolepsy.)
- •Work involving nightshifts.
- •Daily alcohol consumption above 5 units of alcohol (1 unit = 12 g alcohol)
- •Predictable poor compliance (due to pre-existing psychiatric disease, dementia or not able to read or speak sufficient Danish)
- •Pregnant or breastfeeding.
- •Severe, life-threatening medical condition, that implies that the patient cannot participate in the study course. (e.g. metastatic disease, local recurrence, stroke, AMI).
- •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.
研究组 & 干预措施
Melatonin-Placebo sequence
50% of the included patients will receive 4 weeks of treatment with melatonin, followed by a 4 week wash out period, and then 4 weeks of treatment with placebo. The treatments are blinded.
干预措施: Melatonin (Drug)
Melatonin-Placebo sequence
50% of the included patients will receive 4 weeks of treatment with melatonin, followed by a 4 week wash out period, and then 4 weeks of treatment with placebo. The treatments are blinded.
干预措施: Placebo (Drug)
Placebo-Melatonin sequence
50% of the included patients will receive 4 weeks of treatment with placebo, followed by a 4 week wash out period, and then 4 weeks of treatment with melatonin. The treatments are blinded.
干预措施: Melatonin (Drug)
Placebo-Melatonin sequence
50% of the included patients will receive 4 weeks of treatment with placebo, followed by a 4 week wash out period, and then 4 weeks of treatment with melatonin. The treatments are blinded.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Low Anterior Resection Syndrome Score
时间窗: 4 weeks
The LARS Score questionnaire is filled out by the participants before and after each treatment period.
次要结局
- Self-reported quality of life(4 weeks)
- Other patient reported symptoms(4 weeks)
- Daily bowel function(4 weeks)
- Anxiety(4 weeks)
- Multiplex gene assay - NanoString nCounter® Inflammation Panel analysis in blood(4 weeks)
- Depression(4 weeks)
- Sleep(4 weeks)
- Melatonin(4 weeks)
- Insomnia(4 weeks)
- Incidence of treatment-emergent Adverse Effects [Safety and reactions](4 weeks)
- Motilin(4 weeks)
- Pathological assessment of inflammation(4 weeks)
- Multiplex gene assay - NanoString nCounter® Inflammation Panel analysis in biopsies(4 weeks)
- Motilin receptors(4 weeks)
研究者
Ismail Gögenur
Professor
Zealand University Hospital