Status:
COMPLETED
Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Oropharynx Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if minocycline can reduce the symptoms reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of head and neck,...
Detailed Description
The Study Drug: Minocycline is an antibiotic and has been shown to interrupt cytokine production, which may help to reduce multiple symptoms. Study Groups: If you agree to take part in this study, ...
Eligibility Criteria
Inclusion
- Patients with a pathologically proven diagnosis of oropharyngeal cancer, nasopharyngeal cancer, or unknown primary cancer of head and neck in MDACC receiving radiation therapy with or without induction chemotherapy.
- Patients \> = 18 years old.
- Patients with the above cancers, T0, TX, T1 to T3, N any, M0 receiving IMRT (to unilateral or bilateral neck) at least 64-72 Gy in 6-7 weeks as definitive treatment.
- Patients must have normal renal function test and no prior renal disease: The screening cut off for serum creatinine \< upper limit of normal.
- Patients must have normal hepatic function test and no prior liver disease: The screening results for total bilirubin must be \< 1.5 times the upper limit of normal. The screening results for the following must be \< 2 times the upper limit of normal for patients to be eligible: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT). The screening results for Aspartate aminotransferase (AST) must be \< 2 times the upper limit of normal if available.
- Patients who speak English (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol).
- Patients must be willing to discontinue taking dong quai and/or St John's wort.
- Patients must be willing and able to review, understand, and provide written consent.
Exclusion
- Patients receiving concurrent chemotherapy or concurrent biologic agent.
- Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions as determined by the treating physician.
- Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial.
- Bile duct obstruction or cholelithiasis.
- History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction.
- Pre-existing psychosis or bipolar disorder.
- Hypersensitivity to any tetracyclines.
- Patients on anticoagulants (ie warfarin/heparin).
- Patients with INR \> 1.5.
- Patients taking any tetracycline within the last 15 days.
- Patients that are pregnant.
- Patients treated with upfront radical surgery at the primary site (other than diagnostic tonsillectomy or excision).
Key Trial Info
Start Date :
July 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2020
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01173692
Start Date
July 22 2010
End Date
July 7 2020
Last Update
August 20 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030