Prevention of Mucositis in Children With AES-14 (IND#36978), a Glutamine Based Oral Care Regimen, for Patients Diagnosed With Solid Tumors: A Randomized Placebo-Controlled Clinical Study
- Compare the efficacy of a new preparation of glutamine (AES-14) vs placebo in reducing
the incidence of grade 3 or 4 chemotherapy-induced oral mucositis during the first
course of chemotherapy in patients with sarcomas.
- Compare the rates of mucositis-related chemotherapy dose reductions for the subsequent
course of anthracycline-based chemotherapy in patients treated with AES-14 vs placebo.
- Compare the rates of mucositis-related delays of chemotherapy administration for the
next chemotherapy course in patients treated with AES-14 vs placebo.
- Compare the rates of systemic and oral infections during the first course of
chemotherapy in patients treated with AES-14 vs placebo.
- Compare the number of days of narcotic use for mucositis-related pain during the first
course of chemotherapy in patients treated with AES-14 vs placebo.
- Determine the inter-rater reliability between caregivers and nurses in the use of the
modified Walsh scale.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to age (5-10 years vs 11-18 years vs 19-30 years) and diagnosis
(Ewing's sarcoma vs osteogenic sarcoma vs rhabdomyosarcoma vs other sarcomas). Patients are
randomized to 1 of 2 treatment arms.
- Arm I (glutamine [AES-14]): Patients rinse with oral AES-14 for at least 30 seconds and
then swallow (swish and swallow) three times daily beginning on the day of or within 1
day before starting their first course of chemotherapy. Patients also undergo a
standard oral care regimen comprising brushing their teeth at least twice daily, 30
minutes or more after taking AES-14, and rinsing with water at least twice daily.
Treatment continues until blood counts recover and patient's total modified Walsh score
≤ 2 (mucositis score).
- Arm II (placebo): Patients swish and swallow oral placebo and undergo a standard oral
care regimen as in arm I.
Caregivers assess the patient's mouth daily while the patient is receiving the study drug.
Caregivers keep a daily diary rating the patient's oral mucosal areas and degree of pain,
describing the patient's oral intake, and documenting that the study drug was used and
standardized oral care was performed.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Donna L. Betcher, RN, MSN