JDS-17-343.pdf

Study Purpose

To assess the effectiveness of palifermin in preventing mucositis in children with acute lymphocytic leukemia (ALL) undergoing chemotherapy

Intervention Characteristics/Basic Study Process

A clinical trial of 90 children with ALL who were randomized to receive chlorhexidine or palifermin. One group received 60 mcg/kg palifermin as an IV bolus once daily three days before and three days after chemotherapy. The other group received chlorhexidine mouthwash administered once daily three days before and three days after chemotherapy.

Sample Characteristics

N = 90
AGE = 5–18 years
MALES: 44, FEMALES: 46
CURRENT TREATMENT: Chemotherapy
KEY DISEASE CHARACTERISTICS: ALL
OTHER KEY SAMPLE CHARACTERISTICS: Induction chemotherapy protocol consisted of standard risk B-precursor ALL (COG)/dexamethasone, vincristine, L-asparaginase, intrathecal (MTN + Ara C + hydrocortisone). The intensification protocol was dexamethasone, vincristine, L-asparaginase/dexamethasone, cyclophosphamide/6-thioguanine + cytarabine + intrathecal MTX.

Setting

SITE: Single site
SETTING TYPE: Inpatient
LOCATION: Tehran, Iran

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Pediatrics, palliative care

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

The World Health Organization (WHO) Oral Toxicity Scale was used for grading mucositis. The data were analyzed with two-way ANOVA.

Results

The group that used the palifermin had a decreased incidence and severity of chemotherapy-induced mucositis.

Conclusions

Palifermin reduced oral mucositis in children with ALL.

Limitations

Small sample (< 100)
Risk of bias (no blinding)

Nursing Implications

In this study, palifermin has reduced the severity of mucositis in children with ALL who received induction and intensification chemotherapy.