Childhood Malignant Fibrous Histiocytoma of BoneNCT00334984
Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma
A study testing glutamine, chemoprotection and management of therapy complications in people with Childhood Malignant Fibrous Histiocytoma of Bone and Sarcoma, run by Children's Oncology Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 30 years
- Conditions the study is for
- Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma
- What is being tested?
- glutamine, chemoprotection and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Diagnosed with any of the following:
- Ewing's sarcoma
- Osteogenic sarcoma
- Rhabdomyosarcoma
- Other sarcomas (i.e., fibrosarcoma or synovial sarcoma)
- Scheduled to receive first course of chemotherapy that includes ≥ 75 mg/m² of anthracyclines
- Total modified Walsh score ≤ 2 (mucositis score)
PATIENT CHARACTERISTICS:
- Must have a caregiver (parent, other relative, or friend) available to perform daily mucositis assessments
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 5 times ULN
- Albumin ≥ 2 g/dL
- No history of hypersensitivity to any known component of AES-14
PRIOR CONCURRENT THERAPY:
- No prior glutamine (AES-14)
- No prior or concurrent head and/or neck radiation therapy
- No concurrent supplementation with another glutamine product
- No other concurrent agents for mucositis prophylaxis
About this study
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
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.
Read the 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 (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.
- Being tested
- glutamine, chemoprotection, management of therapy complications, therapeutic nutritional supplementation
- Keywords
- childhood fibrosarcoma, childhood neurofibrosarcoma, childhood synovial sarcoma, chondrosarcoma, localized osteosarcoma, metastatic osteosarcoma, metastatic childhood soft tissue sarcoma, nonmetastatic childhood soft tissue sarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, previously treated childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma, childhood alveolar soft-part sarcoma, childhood angiosarcoma, childhood epithelioid sarcoma, childhood leiomyosarcoma, childhood liposarcoma, localized childhood malignant fibrous histiocytoma of bone, metastatic childhood malignant fibrous histiocytoma of bone, childhood malignant mesenchymoma
- Medical subject headings
- Sarcoma, Fibrosarcoma, Chondrosarcoma, Osteosarcoma, Neuroectodermal Tumors, Primitive, Peripheral, Hemangiosarcoma, Liposarcoma, Malignant mesenchymal tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutamineDrug
chemoprotectionProcedure or surgery
management of therapy complicationsProcedure or surgery
therapeutic nutritional supplementationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startJan 2007
Why it stopped: Withdrawn due to inability to reach an acceptable agreement with industry sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Malignant Fibrous Histiocytoma of BoneStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Donna L. Betcher, RN, MSN, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334984
- Sponsor's protocol ID
- ANUR0532
- Other IDs
- COG-ANUR0532, CDR0000469005
- Status last verified
- Jul 2013
- First submitted
- 7 Jun 2006
- Last updated
- 11 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00334984
- Acronym / sponsor ID
- ANUR0532
- Keywords
- childhood fibrosarcoma, childhood neurofibrosarcoma, childhood synovial sarcoma, chondrosarcoma, localized osteosarcoma, metastatic osteosarcoma, metastatic childhood soft tissue sarcoma, nonmetastatic childhood soft tissue sarcoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to inability to reach an acceptable agreement with industry sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- First posted
- 8 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 (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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glutamine | Drug | – |
| chemoprotection | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
| therapeutic nutritional supplementation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna L. Betcher, RN, MSN study chair
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing glutamine, chemoprotection and management of therapy complications in people with Childhood Malignant Fibrous Histiocytoma of Bone and Sarcoma, run by Children's Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.