Clinical trial · Interventional
Care of Cancer Patients With Bowel Injury Caused by Radiation Therapy to the Pelvis
Effective Management of Radiation-induced Bowel Injury: A Randomized Controlled Trial
NCT00737230CI-TRIAL-00011876completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: A step-by-step procedure may help health care practitioners diagnose and treat cancer patients with bowel injury symptoms caused by radiation therapy. PURPOSE: This randomized clinical trial is studying the care of cancer patients with bowel injury caused by radiation therapy to the pelvis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| educational intervention | Other | — | UNRESOLVED |
| gastrointestinal complications management/prevention | Procedure | — | UNRESOLVED |
| management of therapy complications | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Improvement in gastrointestinal symptoms as measured by the modified IBDQ-B score, Rockwood Fecal Incontinence Quality of Life score, St Mark's Incontinence score, and the LENTSOMA score at baseline, 6 months, and 1 year
Secondary outcomes (6)
- measure
- Quality of life as measured by the modified IBDQ and SF-12 questionnaires at baseline, 6 months, and 1 year
- measure
- Anxiety and depression scores as measured by the Hospital Anxiety and Depression Scale questionnaire at baseline, 6 months, and 1 year
- measure
- Other pelvic symptoms (i.e., urinary function as measured by the ICSmaleSF and BFLUTSQ and sexual function as measured by the IIEF-6, ICSsex, and Jensen questionnaires) at baseline, 6 months, and 1 year
- measure
- Cost-effectiveness of diagnostic tests and treatment compared to "usual care" as measured by the ED-5D questionnaire at 6 months and 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Has undergone radical pelvic radiotherapy with curative intent to the prostate, bladder, vulva, vagina, cervix, endometrium, anus, or rectum OR para-aortic irradiation for a tumor at any of these primary sites, including the testes, \> 6 months ago * Has new-onset, troublesome gastrointestinal symptoms that developed \> 6 months after completion of pelvic radiotherapy * Does not require immediate gastroenterological assessment, as deemed by the clinical oncologist * Recruited directly from radiotherapy follow-up clinics at the Royal Marsden Hospital PATIENT CHARACTERISTICS: * Life expectancy \> 1 year PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (1)
- DERIVEDAndreyev HJ, Benton BE, Lalji A, Norton C, Mohammed K, Gage H, Pennert K, Lindsay JO. Algorithm-based management of patients with gastrointestinal symptoms in patients after pelvic radiation treatment (ORBIT): a randomised controlled trial. Lancet. 2013 Dec 21;382(9910):2084-92. doi: 10.1016/S0140-6736(13)61648-7. Epub 2013 Sep 23. PMID 24067488