Low anterior resection syndrome MedDRA version: 20.1 Level: PT Classification code 10080023 Term: Low anterior resection syndrome System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: Melatonin
Product Code: Melatonin
Pharmaceutical Form: Enema
INN or Proposed INN: Melatonin
CAS Number: 73-31-4
Other descriptive name: MELATONIN
Concentration unit: mg milligram(s)
Conc
Sponsors
Zealand University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: After 4 weeks of treatment;Main Objective: The primary objective of the study is to investigate whether treatment with melatonin has an alleviating effect on LARS symptoms. ;Secondary Objective: The secondary objective of the study is to investigate how treatment with melatonin affects movements, other patient reported symptoms, quality of life, depression, anxiety, sleep disturbances, motilin levels, and microscopic changes in rectal mucosa. ;Primary end point(s): The LARS Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Daily registration of bowel function • Quality of life measured by EORTC Quality of Life Questionnaire (QLQ-C30 & QLQ-CR29) • Measure Yourself Medical Outcome Profile (MYMOP) • Anxiety measured by Hospital Anxiety and Depression Scale (HADS-A) • Depression measured by Hospital Anxiety and Depression Scale (HADS-D) • Sleep and circadian outcomes measured by actigraphy. • Insomnia severity measured by Insomnia Severity Index (ISI) • Sleep diary • Safety, adverse events, and reactions and compliance by a standardized interview • Blood tests measuring melatonin and difference in gene expression by nanoString • Pathological assessment of the rectal mucosa • Differences in gene expression of the rectal mucosa by NanoString • Assessment of levels of motilin and motilin receptors ;Timepoint(s) of evaluation of this end point: During the 4 weeks of treatment: • Daily registration of bowel function, actigraphy, and sleep diary After 4 weeks of treatment • All other end-points | — |
Countries
Denmark
Contacts
Public ContactCenter For Surgical Science
Zealand University Hospital
Outcome results
None listed