Minocycline in Oropharynx Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: July 29, 2010
Last updated: January 29, 2014
Last verified: January 2014
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, who receive treatment with radiation therapy.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.
Primary Outcome Measures:
- Combined AUC for Selected Patient Symptoms [ Time Frame: 7 weeks. They will take the study drug/placebo for up to 7 weeks and continue to complete the symptom survey until 15 weeks. ] [ Designated as safety issue: No ]
7-week (+/- 5 days) area under the curve (AUC) for select MDASI-HNC symptoms namely fatigue, pain, sleep disturbance, difficulty swallowing and lack of appetite reported in the symptom survey.
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||July 2015 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo
Twice Daily Orally
Twice daily by mouth, every day for 7 weeks starting at first day of radiation therapy.
Other Name: Sugar Pill
100 mg Twice Daily Orally
100 mg twice daily (200 mg) by mouth , every day for 7 weeks starting first day of radiation therapy.
- Minocin PAC
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173692
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Gary B. Gunn, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 29, 2010
||January 29, 2014
||United States: Food and Drug Administration
Keywords provided by M.D. Anderson Cancer Center:
Head and Neck
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Head and Neck Neoplasms
Neoplasms by Site