E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Low Anterior Resection Syndrome |
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E.1.1.1 | Medical condition in easily understood language |
Bowel dysfunction after surgery for rectal cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10080023 |
E.1.2 | Term | Low anterior resection syndrome |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
TAI is used as a second-line treatment following unsuccessful personalised conservative treatment (PCT) of LARS. However, it is unknown if scheduled, initiated defecation with the aid of a glycerol suppository will have the same clinical effect as TAI. Thus, the aim of this study is to compare the effect of TAI with a glycerol suppository in patients suffering from major LARS. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Sub-study 1: Title: Clinical prospective evaluation of TAI or glycerol suppositories as treatment for low anterior resection syndrome.
Date and version: Version 1.0, 22 May.
Aim:To investigate if patients who experience unsatisfactory improvement of bowel function and QOL by the end of the RCT when treated with glycerol suppositories, will improve on these parameters when treated with TAI and vice versa.
Sub-study 2: Title: Long-term evaluation of TAI and glycerol suppositories for low anterior resection syndrome.
Date and version: Version 1.0, 22 May.
Aim:To investigate long-term effect and adherence of treatment with glycerol suppositories or TAI for low anterior resection syndrome.
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E.3 | Principal inclusion criteria |
1. Patients electively treated for rectal cancer with a low anterior resection. 2. Unsuccessful PCT after at least 4 weeks of treatment for LARS (LARS score >29 at evaluation). 3. At least 3 months after surgery (including reversal of a temporary loop-ileostomy). 4. Age > 18 years 5. Ability to understand written and spoken language actual for the including site (due to questionnaire validity).
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E.4 | Principal exclusion criteria |
1. Former use of TAI 2. Prior systematic use of rectal emptying aids 3. Anastomotic stenosis 4. History of anastomotic leakage 5. Current metastatic disease or local recurrence 6. Ongoing oncological treatment 7. Postoperative radiotherapy for rectal cancer 8. Previous or current cancer in the pelvic organs 9. Underlying diarrhoeal disease 10. Inflammatory bowel disease 11. Dementia 12. Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant neurologic disease assessed to be a contributory cause to LARS symptoms. 13. Inability of patient to use TAI 14. Inability and unwillingness to give informed consent 15. Pregnancy or intention to become pregnant during the trial period |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the improvement of the main symptom using the Measure My Medical Outcome Profile (MYMOP) score comparing the TAI group to the glycerol suppository group. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, 4 weeks, 8 weeks and at closeout in week 12
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E.5.2 | Secondary end point(s) |
1. Assessment of bowel function with the LARS Score and the Memorial Sloan-Kettering Cancer Centre (MSKCC) Bowel Function Instrument (BFI). 2. Assessment of the faecal incontinence status with The St. Mark's Incontinence Score. 3. Assessment of QOL and bowel function-related QOL with the EORTC QLQ-C30 and EORTC QLQ-CR29. 4. Assessment of urinary function with The International Consultation on Incontinence Questionnaire Male/Female Lower Urinary Tract Symptoms (ICIQ-M/F-LUTS). 5. Assessment of sexual function with The Rectal Cancer Female Sexuality Score and The International Index of Erectile Function. 6. LARS international consensus items 7. Health economics 8. EQ5D-5L
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline and closeout at week 12.
Secondary endpoints 1-3 additionally in week 4 and week 8.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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When the last subject of the trial has completed the treatment |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |