Double-blind-randomized,Placebo Controlled Trial for Chemotherapy-associated Oral Mucositis Using Doxycycline Hyclate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Metropolitan Autonomous University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Instituto Nacional de Cancerologia de Mexico
Information provided by:
Metropolitan Autonomous University
ClinicalTrials.gov Identifier:
NCT01087476
First received: March 12, 2010
Last updated: March 15, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Mucositis
Drug: Doxycycline hyclate
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Metropolitan Autonomous University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 164
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)
Arms Assigned Interventions
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.
Other Names:
  • Doryx
  • Doxine
  • Vibramycin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Exclusion criteria

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087476

Contacts
Contact: Velia Ramirez-Amador, PhD 5255 5483 7206 veliaram1@gmail.com
Contact: Gabriela Anaya-Saavedra, PhD 5255 5483 7206 gabyanaya@hotmail.com

Locations
Mexico
Instituto Nacional de Cancerologia Not yet recruiting
Mexico City, Mexico, 140180
Contact: Juan R Labardini-Mendez, MD    56 28 04 00 ext 152    labardini_juan@yahoo.com.mx   
Principal Investigator: Juan R Labardini-Mendez, MD         
Sponsors and Collaborators
Metropolitan Autonomous University
Instituto Nacional de Cancerologia de Mexico
Investigators
Study Director: Sergio Ponce de Leon, MD Instituto Nacional de Ciencias Médicas y Nutrición
  More Information

Publications:
Responsible Party: Dr. Velia A. Ramírez-Amador, Universidad Autonoma Metropolitana-Xochimilco
ClinicalTrials.gov Identifier: NCT01087476     History of Changes
Other Study ID Numbers: MetropolitanAU
Study First Received: March 12, 2010
Last Updated: March 15, 2010
Health Authority: Mexico: Ethics Committee

Keywords provided by Metropolitan Autonomous University:
oral mucositis
chemotherapy
acute leukemia
salivary flow.

Additional relevant MeSH terms:
Stomatitis
Mucositis
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 26, 2014