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Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01173692
Recruitment Status : Completed
First Posted : August 2, 2010
Last Update Posted : July 13, 2020
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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, who receive treatment with radiation therapy.

Condition or disease Intervention/treatment Phase
Oropharynx Cancer Drug: Minocycline Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.
Actual Study Start Date : July 22, 2010
Actual Primary Completion Date : July 3, 2020
Actual Study Completion Date : July 3, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn

Primary Outcome Measures :
  1. 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. ]
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Patients > = 18 years old.
  3. 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.
  4. Patients must have normal renal function test and no prior renal disease: The screening cut off for serum creatinine < upper limit of normal.
  5. 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.
  6. Patients who speak English (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol).
  7. Patients must be willing to discontinue taking dong quai and/or St John's wort.
  8. Patients must be willing and able to review, understand, and provide written consent.

Exclusion Criteria:

  1. Patients receiving concurrent chemotherapy or concurrent biologic agent.
  2. Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions as determined by the treating physician.
  3. Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial.
  4. Bile duct obstruction or cholelithiasis.
  5. History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction.
  6. Pre-existing psychosis or bipolar disorder.
  7. Hypersensitivity to any tetracyclines.
  8. Patients on anticoagulants (ie warfarin/heparin).
  9. Patients with INR > 1.5.
  10. Patients taking any tetracycline within the last 15 days.
  11. Patients that are pregnant.
  12. Patients treated with upfront radical surgery at the primary site (other than diagnostic tonsillectomy or excision).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01173692

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Gary B. Gunn, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01173692    
Other Study ID Numbers: 2010-0096
CA07 ( Other Identifier: NCI )
NCI-2012-01783 ( Registry Identifier: NCI CTRP )
First Posted: August 2, 2010    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Oropharynx Cancer
Radiation Therapy
Head and Neck
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents