The Effect of Melatonin in Patients With Low Anterior Resection Syndrome

NCT05042700 | Unknown Phase 2

• 2 other identifiers: REG-140-20202020-004442-11
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Low Anterior Resection Syndrome Score

  The LARS Score questionnaire is filled out by the participants before and after each treatment period.

  4 weeks

Secondary Outcomes (14)

• Daily bowel function

  4 weeks

• Self-reported quality of life

  4 weeks

• Other patient reported symptoms

  4 weeks

• Anxiety

  4 weeks

• Depression

  4 weeks

Study Arms (2)

Melatonin-Placebo sequence

EXPERIMENTAL

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.

Drug: Melatonin; Drug: Placebo

Placebo-Melatonin sequence

EXPERIMENTAL

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.

Drug: Melatonin; Drug: Placebo

Interventions

Melatonin DRUG

Enema with 25 mg melatonin

Melatonin-Placebo sequence; Placebo-Melatonin sequence

Placebo DRUG

Enema without melatonin

Melatonin-Placebo sequence; Placebo-Melatonin sequence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known allergic reaction to melatonin.
• Dementia as determined by mini mental state examination score (MMSE) \< 24.
• 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.

Sponsors & Collaborators

• Ismail Gögenur: lead
• Hvidovre University Hospital: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

Location

Related Publications (1)

• Zahid JA, Madsen MT, Bulut O, Christensen P, Gogenur I. Effect of melatonin in patients with low anterior resection syndrome (MELLARS): a study protocol for a randomised, placebo-controlled, crossover trial. BMJ Open. 2023 Sep 11;13(9):e067763. doi: 10.1136/bmjopen-2022-067763.

  PMID: 37696629 DERIVED

MeSH Terms

Conditions

Low Anterior Resection Syndrome

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ismail Gögenur, DMSc

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 13, 2021
• Study Start: October 13, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)