Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334984
Status:
WITHDRAWN
Last Update Posted:
2013-07-11
First Post:
2006-06-07
Brief Title:
Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Prevention of Mucositis in Children With AES-14 IND36978 a Glutamine Based Oral Care Regimen for Patients Diagnosed With Solid Tumors A Randomized Placebo-Controlled Clinical Study
Status:
WITHDRAWN
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn due to inability to reach an acceptable agreement with industry sponsor
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
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 Ewings 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 patients 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 patients mouth daily while the patient is receiving the study drug Caregivers keep a daily diary rating the patients oral mucosal areas and degree of pain describing the patients 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
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 Ewings 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 patients 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 patients mouth daily while the patient is receiving the study drug Caregivers keep a daily diary rating the patients oral mucosal areas and degree of pain describing the patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000469005 | None | None | None |
| COG-ANUR0532 | None | None | None |