Care of Cancer Patients With Bowel Injury Caused by Radiation Therapy to the Pelvis

NCT00737230 | Completed

• 3 other identifiers: CDR0000601214RMNHS-CCR2918-ORBITEU-20868
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer

Keywords

long-term effects secondary to cancer therapy in adults; long-term effects secondary to cancer therapy in children; gastrointestinal complications; radiation toxicity; prostate cancer; bladder cancer; vulvar cancer; vaginal cancer; cervical cancer; endometrial cancer; anal cancer; rectal cancer; malignant testicular germ cell tumor

Outcome Measures

Primary Outcomes (1)

• 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)

• Quality of life as measured by the modified IBDQ and SF-12 questionnaires at baseline, 6 months, and 1 year

• Anxiety and depression scores as measured by the Hospital Anxiety and Depression Scale questionnaire at baseline, 6 months, and 1 year

• 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

• Cost-effectiveness of diagnostic tests and treatment compared to "usual care" as measured by the ED-5D questionnaire at 6 months and 1 year

• Cost-effectiveness of nurse practitioner delivery of algorithm compared to gastroenterologist as measured by the ED-5D questionnaire at 6 months and 1 year

Interventions

educational intervention OTHER

questionnaire administration OTHER

assessment of therapy complications PROCEDURE

gastrointestinal complications management/prevention PROCEDURE

management of therapy complications PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

Related Publications (1)

• Andreyev 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 DERIVED

MeSH Terms

Conditions

Neoplasms; Radiation Injuries; Prostatic Neoplasms; Urinary Bladder Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Anus Neoplasms; Rectal Neoplasms; Testicular Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Wounds and Injuries; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases; Genital Neoplasms, Female; Vulvar Diseases; Genital Diseases, Female; Vaginal Diseases; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Jervoise Andreyev, MD

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: HEALTH SERVICES RESEARCH
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: April 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: July 1, 2012
• Last Updated: August 26, 2013

Record last verified: 2009-06

Locations

GB (1)