Overview

Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Traumeel® S (a mouth rinse) may be effective in preventing or decreasing the severity of oral mucositis caused by chemotherapy in young patients who are undergoing stem cell transplantation. PURPOSE: This randomized clinical trial is studying how well Traumeel® S works in preventing or treating mucositis in young patients who are receiving chemotherapy with or without total-body irradiation before undergoing stem cell transplantation.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Criteria
DISEASE CHARACTERISTICS:

- Planned treatment with allogeneic or autologous hematopoietic stem cell
transplantation

- Conditioning chemotherapy regimen for transplantation must be myeloablative

- Source of stem cells from any of the following:

- Bone marrow

- Placental cord

- Cytokine-mobilized peripheral blood

- Availability of 1 of the following donor types:

- HLA-matched sibling or parent

- Related donor mismatched for a single HLA locus (class I or II)

- Unrelated marrow or peripheral blood stem cell donor

- Unrelated umbilical cord blood HLA-matched or mismatched (class I) donor

PATIENT CHARACTERISTICS:

Age

- 3 to 25

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- No known allergy to Echinacea

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No concurrent oral vancomycin paste

- No concurrent oral glutamine supplementation

- No other mouth care or oral medications within 30 minutes after administration of
study drugs

- No other concurrent treatment to prevent mouth sores