Sucralfate is an ulcer drug that has an anti-inflammatory effect on the gastrointestinal mucosa. The drug causes an increase in the level of prostaglandins and binds basic fibroblast growth factor (bFGF), protecting it from acid degradation. It is angiogenic, increasing blood flow. Systemic use with oral administration has been studied for diarrhea, mucositis and radiodermatitis. Topical use has been tested as an intervention for radiodermatitis.
Not Recommended for Practice
Gibson, R.J., Keefe, D.M., Lalla, R.V., Bateman, E., Blijlevens, N., Fijlstra, M., … Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). (2013). Systematic review of agents for the management of gastrointestinal mucositis in cancer patients. Supportive Care in Cancer, 21(1), 313–326.doi: 10.1007/s00520-012-1644-z
Purpose & Patient Population:
To systematically review current evidence for prevention and treatment of gastrointestinal (GI) mucositis in adults and children receiving cancer treatment and to update relevant Multinational Association of Supportive Care in Cancer (MASCC) guidelines
Type of Resource/Evidence-Based Process:
This was an evidence-based guideline developed based on a systematic review of the literature with rating of levels of evidence and identification of study flaws.
Database searched was MEDLINE.
Search keywords were numerous and included all known possible interventions tested.
Inclusion and exclusion criteria were not stated in this article but provided elsewhere in the journal.
Phase of Care and Clinical Applications:
- Patients were undergoing the active treatment phase of care.
- The study has clinical applicability for pediatrics.
Results Provided in the Reference:
A total of 1,336 papers were initially retrieved; of these, 146 were reviewed for development of the guidelines.
Guidelines & Recommendations:
- Probiotics with Lactobacillus spp. may be beneficial for prevention of chemotherapy- and radiotherapy-induced diarrhea in patients with pelvic malignancies. Two studies with positive results were cited.
- Amifostine may reduce esophagitis because of concomitant radiation and chemotherapy. It is not recommended in other situations because of conflicting evidence.
- Mesalazine, 5-aminosalicylic acid (5-ASA), and olsalazine are not recommended because they have been associated with increased diarrhea compared to placebo.
- Sucralfate is not recommended for diarrhea prevention because it is associated with increased GI side effects, including rectal bleeding.
- Oral sulfasalazine given at 500 mg twice daily is recommended to reduce incidence and severity of radiation-induced enteropathy.
- No guideline was provided for glutamine, but three new studies were sited that showed promising results.
- If loperamide has not resulted in diarrhea control with standard or high-dose chemotherapy in HCTY patients, 100 mcg or greater of subcutaneous octreotide twice daily is recommended.
This review had a limited search strategy, as only one database was searched. In addition, most of the suggestions and recommendations provided were based on low-level evidence by the rating system used.
These guidelines provide some suggestions for management of oral mucositis and diarrhea in patients with cancer. They also provide information regarding evidence for mucositis in the entire GI tract.
Research Evidence Summaries
Martenson, J.A., Bollinger, J.W., Sloan, J.A., Novotny, P.J., Urias, R.E., Michalak, J.C., … Levitt, R. (2000). Sucralfate in the prevention of treatment-induced diarrhea in patients receiving pelvic radiation therapy: A North Central Cancer Treatment Group phase III double-blind placebo-controlled trial. Journal of Clinical Oncology, 18(6), 1239–1245.
Intervention Characteristics/Basic Study Process:
Patients receiving pelvic external beam radiation therapy were randomly assigned to receive sulcrafate (2 gm four times per day) or placebo.
The study reported on 123 evaluable patients. The treatment group consisted of 62 patients, and the placebo group consisted of 61 patients. The two groups were balanced in terms of factors such as diagnosis, functional status, radiation dosage, and tumor status.
This was a double-blind, randomized controlled trial.
- Patients reported the number bowel movements, use of protective clothing, and symptoms of cramping, blood, nocturnal bowel movements, and fecal incontinence weekly via a questionnaire.
- Physicians assessed diarrhea, tenesmus, cramping, bleeding, nausea, and constipation using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
More patients in the treatment group reported fecal incontinence and a need for protective clothing than in the control group (34% versus 16%, p = 0.04). Physician-reported severity of nausea was worse in the treatment group compared to the control group (p = 0.3), although this was not a specific study endpoint.
Sulcrafate did not decrease pelvic radiation therapy-related bowel toxicity by any of the endpoints measured and seems to have aggravated some gastrointestinal symptoms.
Although the patient questionnaire approximated the physician scale, provider assessments of subjective data such as cramping and straining can be unreliable if not obtained directly from the subject.