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Low Anterior Resection SyndromePhase 2MELLARSNCT05042700

The Effect of Melatonin in Patients With Low Anterior Resection Syndrome

A Phase 2 study testing Melatonin in people with Low Anterior Resection Syndrome, run by Ismail Gögenur at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Anterior Resection Syndrome
What is being tested?
Melatonin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteDenmark
Study dates
13 Oct 2021to Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Known allergic reaction to melatonin.
  • Dementia as determined by mini mental state examination score (MMSE) < 24.
  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Zealand University Hospital

    Køge, Region Sjælland, 4600

Other trials in Denmark

About this study

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.

Read the detailed description

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.

Being tested
Melatonin, Placebo
Medical subject headings
Low Anterior Resection Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MelatoninDrug

    Enema with 25 mg melatonin

  • PlaceboDrug

    Enema without melatonin

Study groups in NCT05042700
Study groupRoleWhat they receive
Melatonin-Placebo sequenceExperimental50% 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.
Receives: Drug: Melatonin; Drug: Placebo
Placebo-Melatonin sequenceExperimental50% 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.
Receives: Drug: Melatonin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Low Anterior Resection Syndrome Score

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

    Measured: 4 weeks

Secondary outcomes (14)

  1. Daily bowel function

    The participants will fill out a diary on the daily bowel movements during the treatment phase

    Measured: 4 weeks

  2. Self-reported quality of life

    EORTC Quality of Life Questionnaire for cancer patients and specifically colorectal cancer patients

    Measured: 4 weeks

  3. Other patient reported symptoms

    Measure Yourself Medical Outcome Profile (MYMOP) is a self-administered questionnaire. Patients are asked to specify one or two symptoms that concern them the most. Subsequently they evaluate the severity on a 7-point Likert scale. The second part of the questionnaire uses the same scale to assess whether the symptom limits or prevent any daily activity, and also to rate general well-being. Follow-up questionnaires address the original issues completed in the initial form. Symptom 1, symptom 2, activity, and wellbeing each have a separate score between 0 and 6 with 0 indicating "as good as it could be" and 6 "as bad as it could be". An overall score is calculated by taking the average of item scores.

    Measured: 4 weeks

  4. Anxiety

    Hospital Anxiety and Depression Scale (HADS-A): The anxiety subscale consists of 7 questions which are graded on a 4 point scale (0-1-2-3) and is summed into a total score between 0-21. A score of 7 or lower is negative case, a score of 8 - 10 is a doubtful case, and a score of 11 or above is a positive case.

    Measured: 4 weeks

  5. Depression

    Hospital Anxiety and Depression Scale (HADS-D): The depression subscale consists of 7 questions which are graded on a 4 point scale (0-1-2-3) and is summed into a total score between 0-21. A score of 7 or lower is negative case, a score of 8 - 10 is a doubtful case, and a score of 11 or above is a positive case.

    Measured: 4 weeks

  6. Sleep

    Participants will wear an actigraph during the treatment phases and fill out a sleep diary and this will allow to asses sleep time (minutes).

    Measured: 4 weeks

  7. Insomnia

    Insomnia Severity Index (ISI)

    Measured: 4 weeks

  8. Incidence of treatment-emergent Adverse Effects [Safety and reactions]

    Participants will be systematically interviewed before and after the treatment periods.

    Measured: 4 weeks

  9. Melatonin

    Blood samples will be taken after each treatment ends.

    Measured: 4 weeks

  10. Multiplex gene assay - NanoString nCounter® Inflammation Panel analysis in blood

    Difference in gene expressions between intervention and placebo groups

    Measured: 4 weeks

  11. Motilin

    Blood samples will be taken after each treatment ends.

    Measured: 4 weeks

  12. Pathological assessment of inflammation

    Rectal biopsies will be taken after each treatment ends.The FFPE treated biopsies will be assessed by pathologist using a routine inflammatory grading system to asses inflammation

    Measured: 4 weeks

  13. Multiplex gene assay - NanoString nCounter® Inflammation Panel analysis in biopsies

    Difference in gene expressions between intervention and placebo groups

    Measured: 4 weeks

  14. Motilin receptors

    Rectal biopsies will be taken after each treatment ends.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2021
  2. Study start13 Oct 2021
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05042700
Sponsor's protocol ID
REG-140-2020
Other IDs
2020-004442-11
Acronym
MELLARS
Status last verified
Apr 2023
First submitted
30 Aug 2021
Last updated
25 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37696629

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Melatonin in people with Low Anterior Resection Syndrome, run by Ismail Gögenur at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Low Anterior Resection Syndrome Score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05042700, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.

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