Double-blind-randomized,Placebo Controlled Trial for Chemotherapy-associated Oral Mucositis Using Doxycycline Hyclate
Recruitment status was: Not yet recruiting
Background. Mucositis is a complication of chemotherapy with no effective treatment. Aim.To evaluate the efficacy of sub-microbial doses of doxycycline hyclate in preventing the development of oral mucositis in patients with acute leukemia (AL) treated with induction chemotherapy.
Hypothesis. Doxycycline hyclate administration in sub-microbial dosage will reduce the incidence of oral mucositis in patients with AL who receive induction chemotherapy.
Methods. Double-blind, randomized, placebo-controlled clinical trial. At the Cancer National Institute (INCan), adult patients (> 18 years of age) with acute leukemia of recent diagnosis, scheduled to receive induction chemotherapy will be enrolled in the study. Written informed consent from the patients will be obtained preceding inclusion in the study.
At baseline and 3-times per week, during 21-days, patients will have an oral examination performed using the Oral Mucositis Assessment Scale (OMAS), oral pain, difficulty to swallow, and salivary flow measurements will be recorded.
A sample size of 164 subjects has been calculated, 74 subjects in each arm of the study. The primary end point of this study to evaluate the efficacy will be the proportion of patients treated with doxycycline or placebo without oral lesions associated with OM, during the 21 days of follow-up. Efficacy will be evaluated if the proportion of complete response (CR) is significantly higher than the proportion of events in the placebo group. Additional secondary endpoints will be the partial resolution of the oral lesions, the incidence of infections and the mortality in the study groups during the 21 days of follow-up. Results will be analyzed by using Chi-squared test and Wilcoxon-Mann-Whitney rank sum test.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Phase 2 Double-blind, Randomized, Placebo Controlled Clinical Trial for the Prevention of Oral Mucositis Using Sub-microbial Doses of Doxycycline Hyclate in Patients With Acute Leukemia Receiving Induction Chemotherapy|
- Complete response [ Time Frame: At baseline and 3-times per week, during 21-days after chemotherapy. ] [ Designated as safety issue: Yes ]Complete response will be evaluated through the OMAS score.
- Partial resolution of oral lesions, incidence of infections and mortality. [ Time Frame: At baseline and 3-times per week, during 21-days after chemotherapy. ] [ Designated as safety issue: Yes ]Partial response will be evaluated through the OMAS score. The incidence of infections and the mortality in the study groups during the 21 days of follow-up.To confirm the diagnosis of oral candidosis (OC), the identification of pseudohyphae in exfoliative cytology samples stained with periodic acid Schiff, will be necessary. The clinical diagnosis of herpes simplex virus (HSV) induced will be confirmed by the virus-infected cells demonstrated in cytologic smears stained with Papanicolaou, and/or a clinical response to systemic antiviral therapy with acyclovir.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: doxycycline hyclate
Patients will be randomly assigned to receive either a sub-microbial dose of doxycycline hyclate or placebo (50 mg per day), immediately before the initiation of induction chemotherapy and daily during the following 21 days after chemotherapy.
Drug: Doxycycline hyclate
Sub-microbial dose of Doxycycline hyclate or placebo (50 mg per day), immediately before the initiation of induction chemotherapy and daily during the following 21 days after chemotherapy.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01087476
|Instituto Nacional de Cancerologia|
|Mexico City, Mexico, 140180|
|Study Director:||Sergio Ponce de Leon, MD||Instituto Nacional de Ciencias Médicas y Nutrición|