Minocycline in Oropharynx Cancer
This study is currently recruiting participants.
Verified December 2012 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01173692
First received: July 29, 2010
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Oropharynx Cancer |
Drug: Minocycline Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study. |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
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: | 40 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Twice Daily Orally
|
Drug: Placebo
Twice daily by mouth, every day for 7 weeks starting at first day of radiation therapy.
Other Name: Sugar Pill
|
|
Experimental: Minocycline
100 mg Twice Daily Orally
|
Drug: Minocycline
100 mg twice daily (200 mg) by mouth , every day for 7 weeks starting first day of radiation therapy.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 <1.5mg/dl.
- Patients must have normal hepatic function test and no prior liver disease: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 Criteria:
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173692
Contacts
| Contact: Gary B. Gunn, MD | 713-745-3470 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Gary B. Gunn, MD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Gary B. Gunn, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01173692 History of Changes |
| Other Study ID Numbers: | 2010-0096 |
| Study First Received: | July 29, 2010 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Oropharynx Cancer Radiation Therapy XRT Radiotherapy |
Minocycline Symptoms Head and Neck |
Additional relevant MeSH terms:
|
Oropharyngeal Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Neoplasms Pharyngeal Diseases |
Stomatognathic Diseases Otorhinolaryngologic Diseases Minocycline Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013