Double-blind-randomized,Placebo Controlled Trial for Chemotherapy-associated Oral Mucositis Using Doxycycline Hyclate
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
1 other identifier
interventional
164
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2010
CompletedFirst Posted
Study publicly available on registry
March 16, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMarch 16, 2010
March 1, 2010
1.1 years
March 12, 2010
March 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete response
Complete response will be evaluated through the OMAS score.
At baseline and 3-times per week, during 21-days after chemotherapy.
Secondary Outcomes (1)
Partial resolution of oral lesions, incidence of infections and mortality.
At baseline and 3-times per week, during 21-days after chemotherapy.
Study Arms (1)
doxycycline hyclate
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adult patients (\> 18 years of age) with acute leukemia of recent diagnosis,scheduled to receive induction chemotherapy.
- Capacity to give written informed consent.
- Ability to attend the follow-up visits.
You may not qualify if:
- Patients with allergy or intolerance to tetracyclines
- Patients with acute or chronic renal insufficiency (basal blood creatinine \>1.9 mg/dl)
- Patients with the contraindication for the oral administration of drugs.
- Patients with active septic processes or considered resolved in less than 7 days before the start of chemotherapy.
- Patients who required tetracycline administration in the 28 days previous to randomization.
- Adult patients with acute leukemia schedule to undergo stem-cell transplantation in the following two weeks.
- Adult patients with hematological cancer with previous radiotherapy that may affect the salivary glands.
- Inability to authorize a written informed consent.
- Patients who start chemotherapy before 12 hours of the assigned treatment.
- Patients who have received less than 10 doses (5 days) of the assigned treatment.
- Requirement to receive ergot derivates.
- Patients who require the administration of acitretin/isotretinoin/tretinoin
- Patients that receive photosensitive drugs during the study period (hydroxyquinone/retinoids or methoxsalen)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Cancerologia
Mexico City, Mexico City, 140180, Mexico
Related Publications (1)
Ramirez-Amador V, Anaya-Saavedra G, Crespo-Solis E, Camacho EI, Gonzalez-Ramirez I, Ponce-de-Leon S. Prospective evaluation of oral mucositis in acute leukemia patients receiving chemotherapy. Support Care Cancer. 2010 May;18(5):639-46. doi: 10.1007/s00520-009-0708-1. Epub 2009 Aug 6.
PMID: 19655176BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sergio Ponce de Leon, MD
Instituto Nacional de Ciencias Médicas y Nutrición
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 12, 2010
First Posted
March 16, 2010
Study Start
May 1, 2010
Primary Completion
June 1, 2011
Study Completion
February 1, 2013
Last Updated
March 16, 2010
Record last verified: 2010-03