CompletedNot Applicable

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

United States, Australia, Canada195 participantsStarted 2004-04

Plain-language 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.

Who can participate

Age range

3 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the curve (AUC) of the modified Walsh mucositis scale

Timeframe: Length of study

Trial details

NCT IDNCT00080873

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2006-11

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