Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation
A Phase II/III Blinded Randomized Trial to Determine the Efficacy of Low Energy Diode Laser Therapy (650 nm or 780 nm) to Prevent Oral Mucositis Following Bone Marrow Transplantation
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES: I. Determine whether low-energy laser therapy can prevent oral mucositis in patients undergoing bone marrow transplantation.
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.
Studietype
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Studiesteder
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Washington
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Seattle, Washington, Forente stater, 98109-1024
- Fred Hutchinson Cancer Research Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
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
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Mark M. Schubert, DDS, MSD, Fred Hutchinson Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
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Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1001.00
- FHCRC-1001.00
- NCI-G01-2008
- CDR0000068886 (Registeridentifikator: PDQ)
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