This is the current release of the guideline.

This guideline updates a previous version: Rubenstein EB, Peterson DE, Schubert M, et al. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer 2004 May 1;100(9 Suppl):2026-46.

The grades of recommendations (A–D) and levels of evidence (I-V) are defined at the end of the "Major Recommendations" field.

Note: The following guidelines represent the integration of the original guidelines from 2002 plus the updated guidelines developed at the Geneva, Switzerland workshop of 2005. Recommendation grades and levels of evidence for recommendations that were not updated come from the previous version of the guideline (see the "Availability of Companion Documents" field).

Summary of Evidence-based Clinical Practice Guidelines for Care of Patients with Oral and Gastrointestinal Mucositis (2005 Update)

1. Oral Mucositis

   Basic Oral Care and Good Clinical Practices

   1. The panel suggests multidisciplinary development and evaluation of oral care protocols, and patient and staff education in the use of such protocols to reduce the severity of oral mucositis from chemotherapy and/or radiation therapy (Level III evidence, grade B suggestion). As part of the protocols, the panel suggests the use of a soft toothbrush that is replaced on a regular basis. Elements of good clinical practice should include the use of validated tools to regularly assess oral pain and oral cavity health. The inclusion of dental professionals is vital throughout the treatment and follow-up phases.
   2. The panel recommends patient-controlled analgesia with morphine as the treatment of choice for oral mucositis pain in patients undergoing hematopoietic stem cell transplantation (HSCT) (Level 1 evidence, grade A recommendation). Regular oral pain assessment using validated instruments for self-reporting is essential.

   Radiotherapy: Prevention

   3. The panel recommends the use of midline radiation blocks and 3-dimensional radiation treatment to reduce mucosal injury. (Level 2 evidence, grade B recommendation)
   4. The panel recommends benzydamine for prevention of radiation-induced mucositis in patients with head and neck cancer receiving moderate-dose radiation therapy. (Level I evidence, grade A recommendation)
   5. The panel recommends that chlorhexidine not be used to prevent oral mucositis in patients with solid tumors of the head and neck who are undergoing radiotherapy. (Level II evidence, grade B recommendation)
   6. The panel recommends that antimicrobial lozenges not be used for the prevention of radiation-induced oral mucositis. (Level II evidence, grade B recommendation)

   Radiotherapy: Treatment

   7. The panel recommends that sucralfate not be used for the treatment of radiation-induced oral mucositis. (Level II evidence, grade A recommendation)

   Standard-Dose Chemotherapy Prevention

   8. The panel recommends that patients receiving bolus 5-fluorouracil (5-FU) chemotherapy undergo 30 minutes of oral cryotherapy to prevent oral mucositis. (Level II evidence, grade A recommendation)
   9. The panel suggests the use of 20 to 30 minutes of oral cryotherapy to decrease mucositis in patients treated with bolus doses of edatrexate. (Level IV evidence, grade B suggestion)
   10. The panel recommends that acyclovir and its analogues not be used routinely to prevent mucositis. (Level II evidence, grade B recommendation)

   Standard-Dose Chemotherapy: Treatment

   11. The panel suggests that chlorhexidine not be used to treat established oral mucositis. (Level III evidence, grade C recommendation)

   High-Dose Chemotherapy With or Without Total Body Irradiation Plus HCST: Prevention

   12. In patients with hematologic malignancies who are receiving high-dose chemotherapy and total body irradiation with autologous stem cell transplantation, the panel recommends the use of keratinocyte growth factor-1 (palifermin) in a dose of 60 micrograms/kg per day for 3 days prior to conditioning treatment and for 3 days posttransplantation for the prevention of oral mucositis. (Level 1 evidence, grade A recommendation)
   13. The panel suggests the use of cryotherapy to prevent oral mucositis in patients receiving high-dose melphalan. (Level II evidence, grade A recommendation)
   14. The panel does not recommend the use of pentoxifylline to prevent mucositis in patients undergoing HSCT. (Level II evidence, grade B recommendation)
   15. The panel suggests that granulocyte macrophage colony-stimulating factor (GM-CSF) mouthwashes not be used for the prevention of oral mucositis in patients undergoing HSCT. (Level II evidence, grade C recommendation)
   16. The panel suggests the use of low-level laser therapy (LLLT) to reduce the incidence of oral mucositis and its associated pain in patients receiving high-dose chemotherapy or chemoradiotherapy before HSCT if the treatment center is able to support the necessary technology and training, because LLLT requires expensive equipment and specialized training. Because of interoperator variability, clinical trials are difficult to conduct, and their results are difficult to compare; nevertheless, the panel is encouraged by the accumulating evidence in support of LLLT. (Level II evidence, grade B recommendation)

2. Gastrointestinal (GI) Mucositis

   Basic Bowel Care and Good Clinical Practices

   17. The panel suggests that basic bowel care should include the maintenance of adequate hydration, and that consideration should be given to the potential for transient lactose intolerance and the presence of bacterial pathogens. (Level IV evidence, grade D suggestion)

   Radiotherapy: Prevention

   18. The panel suggests the use of 500 mg sulfasalazine orally twice daily to help reduce the incidence and severity of radiation-induced enteropathy in patients receiving external beam radiotherapy to the pelvis. (Level II evidence, grade B recommendation)
   19. The panel suggests that amifostine in a dose >340 mg/m² may prevent radiation proctitis in patients who are receiving standard-dose radiotherapy for rectal cancer. (Level III evidence, grade B suggestion)
   20. The panel recommends that oral sucralfate not be used to reduce related side effects of radiotherapy; it does not prevent acute diarrhea in patients with pelvic malignancies undergoing external beam radiotherapy; and, compared with placebo, it is associated with more GI side effects, including rectal bleeding. (Level I evidence, grade A recommendation)
   21. The panel recommends that 5-amino salicylic acid and its related compounds mesalazine and olsalazine not be used to prevent GI mucositis. (Level I evidence, grade A recommendation)

   Radiotherapy: Treatment

   22. The panel suggests the use of sucralfate enemas to help manage chronic radiation-induced proctitis in patients who have rectal bleeding. (Level III evidence, grade B suggestion)

   Standard-Dose and High-Dose Chemotherapy: Prevention

   23. The panel recommends either ranitidine or omeprazole for the prevention of epigastric pain after treatment with cyclophosphamide, methotrexate, and 5-FU or treatment with 5-FU with or without folinic acid chemotherapy. (Level II evidence, grade A recommendation)
   24. The panel recommends that systemic glutamine not be used for the prevention of GI mucositis. (Level II evidence, grade C recommendation)

   Standard-Dose and High-Dose Chemotherapy: Treatment

   25. When loperamide fails to control diarrhea induced by standard-dose or high-dose chemotherapy associated with HSCT, the panel recommends octreotide at a dose >100 micrograms subcutaneously, twice daily. (Level II evidence, grade A recommendation)

   Combined Chemotherapy and Radiotherapy: Prevention

   26. The panel suggests the use of amifostine to reduce esophagitis induced by concomitant chemotherapy and radiotherapy in patients with nonsmall cell lung cancer. (Level III evidence, grade C suggestion)

Definitions:

Levels of Evidence

Level I evidence is reserved for meta-analyses of randomized controlled trials or randomized trials with high power.

Level II evidence includes randomized trials with lower power.

Level III evidence includes nonrandomized trials, such as cohort or case-controlled series.

Level IV evidence includes descriptive and case studies.

Level V evidence includes case reports and clinical examples.

Recommendation Grades

Grade A is reserved for Level I evidence or consistent findings from multiple studies of Level II, III, or IV evidence.

Grade B is for Level II, III, or IV evidence with generally consistent findings.

Grade C is similar to grade B but with inconsistencies.

Grade D implies little or no evidence.

Guideline Classification and Hierarchy*

Recommendation: A recommendation is reserved for guidelines that are based on Level I or Level II evidence.

Suggestion: A suggestion is used for guidelines that are based on Level III, Level IV, and Level V evidence; this implies panel consensus on the interpretation of this evidence.

No guideline possible: No guideline possible is used when there is insufficient evidence on which to base a guideline; this conclusion implies 1) that there is little or no evidence regarding the practice in question, or 2) that the panel lacks a consensus on the interpretation.

*Used with permission from the publisher. Adapted from: Somerfield M, Padberg J, Pfister D, et al. ASCO clinical practice guidelines: process, progress, pitfalls, and prospects. Classic Pap Curr Comments.

None provided

The type of supporting evidence is identified and graded for the updated recommendations (see "Major Recommendations").

Not applicable: The guideline was not adapted from another source.

2004 (revised 2008 Feb)

International Society for Oral Oncology - Disease Specific Society
Multinational Association of Supportive Care in Cancer - Disease Specific Society

Multinational Association of Supportive Care in Cancer and the International Society for Oral Oncology

Not stated

Dorothy M. Keefe, MD; Mark M. Schubert, DDS, MSD; Linda S. Elting, DrPH; Stephen T. Sonis, DMD, DMSc; Joel B. Epstein, DMD, MSD; Judith E. Raber-Durlacher, DDS, PhD; Cesar A. Migliorati, DDS, PhD; Deborah B. McGuire, PhD, RN; Ronald D. Hutchins, MSLS; Douglas E. Peterson, DMD, PhD; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer and the International Society for Oral Oncology (MASCC/ISOO)

The costs for the workshop and for administrative assistance in guideline preparations were paid from unrestricted educational grants made to the Mucositis Study Group of Multinational Association of Supportive Care in Cancer and the International Society for Oral Oncology (MASCC/ISOO). No representatives from any of the companies that provided grants attended the workshop, nor were they allowed access to the guidelines prior to publication. The guideline development process was determined entirely by the panel. Each panel member completed a conflict-of interest disclosure form that revealed all relationships with pharmaceutical companies that could be affected by the development and publication of these guidelines.

Mark M. Schubert is currently an advisory board participant for MGI Pharma and on the speakers' bureau (Kepivance) for Amgen; previously he has served as an advisory board participant for McNeil Pharmaceuticals and on the speakers' bureau for OSI.

This is the current release of the guideline.

This guideline updates a previous version: Rubenstein EB, Peterson DE, Schubert M, et al. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer 2004 May 1;100(9 Suppl):2026-46.

None available

This NGC summary was completed by ECRI Institute on April 17, 2008. The information was verified by the guideline developer on May 19, 2008.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.