Clinical Trial: Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: 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

Brief Summary:

RATIONALE: Glutamine may help prevent mucositis, or mouth sores, in patients receiving chemotherapy for sarcoma. It is not yet known whether glutamine is more effective than a placebo in preventing mucositis in patients receiving chemotherapy for sarcoma.

PURPOSE: This randomized clinical trial is studying glutamine to see how well it works compared to a placebo in preventing oral mucositis in patients receiving chemotherapy for sarcoma.

Detailed Summary:

OBJECTIVES:

Primary

• 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.

Secondary

• 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
  Sponsor: Children's Oncology Group
  

  Current Primary Outcome:
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Children's Oncology Group
  

  Dates:
  Date Received: June 7, 2006
  Date Started: January 2007
  Date Completion:
  Last Updated: July 9, 2013
  Last Verified: July 2013