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Comparison of granulocyte-macrophage colony-stimulating factor and sucralfate mouthwashes in the prevention of radiation-induced mucositis: a double-blind prospective randomized phase III study.

Abstract

PURPOSE

To compare granulocyte-macrophage colony-stimulating factor (GM-CSF) mouthwashes with sucralfate mouthwashes in the prevention of radiation-induced mucositis.

METHODS AND MATERIALS

Forty patients with radically operated head-and-neck cancer were randomly allocated to use either GM-CSF (n = 21) or sucralfate (n = 19) mouthwashes during postoperative radiotherapy (RT). All patients received conventionally fractionated RT to a total dose of 50-60 Gy in 2-Gy daily fractions during 5-6 weeks to the primary site and regional lymphatics. A minimum of 50% of the oral cavity and oropharyngeal mucosa was included in the clinical target volume. GM-CSF mouthwashes consisted of 37.5 microg GM-CSF and sucralfate mouthwashes of 1.0 g of sucralfate distilled in water. Both washes were used 4 times daily, beginning after the first week of RT and continued to the end of the RT course. Symptoms related to radiation mucositis and body weight, serum prealbumin level, and blood cell counts were monitored weekly.

RESULTS

Oral mucositis tended to be less severe in the GM-CSF group (p = 0.072). Complete (n = 1) or partial (n = 4) healing of mucositis occurred during the RT course in 5 patients (24%) in the GM-CSF group and in none of the patients in the sucralfate group (p = 0.049). Patients who received GM-CSF had less mucosal pain (p = 0.058) and were less often prescribed opioids for pain (p = 0.042). Three patients in the sucralfate group needed hospitalization for mucositis during RT compared with none in the GM-CSF group. Four patients (21%) in the sucralfate group and none in the GM-CSF group required an interruption in the RT course (p = 0.042). No significant differences in weight, prealbumin level, or blood cell count were found between the groups, and both mouthwashes were well tolerated.

CONCLUSION

GM-CSF mouthwashes may be moderately more effective than sucralfate mouthwashes in preventing radiation-induced mucositis and mucositis-related pain, and their use may lead to less frequent RT course interruptions from mucositis. The present findings need to be confirmed before adopting GM-CSF mouthwashes in routine clinical use.

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  • Authors+Show Affiliations

    ,

    Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland. kauko.saarilahti@hus.fi

    , , ,

    Source

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Anti-Ulcer Agents
    Double-Blind Method
    Female
    Granulocyte-Macrophage Colony-Stimulating Factor
    Head and Neck Neoplasms
    Humans
    Leukocyte Count
    Male
    Middle Aged
    Mouth Mucosa
    Mouthwashes
    Neutrophils
    Prospective Studies
    Radiation Injuries
    Stomatitis
    Sucralfate
    Weight Loss

    Pub Type(s)

    Clinical Trial
    Clinical Trial, Phase III
    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    12243825