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Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation Clinical research trials and Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation. Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation clinical trial. Subjects typically recieve the finest healthcare available for their Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation  Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation
Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation
For Condition: oral complications of cancer and cancer therapy
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: RATIONALE: Laser therapy may reduce the severity of symptoms and speed healing of oral mucositis. It is not yet known if laser therapy is effective in preventing oral mucositis. PURPOSE: Randomized phase II/III trial to determine the effectiveness of laser therapy in preventing oral mucositis in patients who are undergoing bone marrow transplantation.
Details: OBJECTIVES: I. Determine whether low-energy laser therapy can prevent oral mucositis in patients undergoing bone marrow transplantation. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of three treatment arms. Arm I: Patients undergo low-energy laser therapy with visible red light (650 nm) daily over 15-20 minutes beginning on the first day of their transplant conditioning regimen and continuing until day 2 after bone marrow transplantation. Arm II: Patients undergo low-energy laser therapy with invisible infra-red light (780 nm) daily on the same schedule as in arm I. Arm III: Patients undergo sham laser therapy daily on the same schedule as in arm I. Patients are followed on days 3, 7, 10, 14, 18, 21, and 24. PROJECTED ACCRUAL: A total of 66 patients (22 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 12 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - At risk of developing oral mucositis due to toxicity resulting from one of the following: Preparative chemoradiotherapy; Multiple drug conditioning regimens; Graft-versus-host disease (GVHD) prophylaxis --Prior/Concurrent Therapy-- - Not currently enrolled on other protocols with oral mucositis as a stated end point (e.g., conditioning regimen toxicity trials or GVHD prophylaxis trials); No other concurrent investigational drugs or agents for the prevention or treatment of mucositis; No concurrent photosensitizing agents --Patient Characteristics-- - Age: Over 12 - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: Able to carry out routine oral care; No active oral, viral, bacterial, or fungal infections; No active uncontrolled oral bleeding that would preclude laser therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkSchubert, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Additional Information:
Study ID Numbers: CDR0000068886; NCI-G01-2008,FHCRC-1001.00
Study Start Date: April 1995
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024037
Other Oral Complications Of Cancer And Cancer Therapy Studies:
1. Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation
2. Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx
3. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
4. Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation
5. Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
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Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation
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