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

NCT01173692 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 2010-0096CA07NCI-2012-01783
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharynx Cancer

Keywords

Oropharynx Cancer; Radiation Therapy; XRT; Radiotherapy; Minocycline; Symptoms; Head and Neck

Outcome Measures

Primary Outcomes (1)

• Combined AUC for Selected Patient Symptoms

  7-week (+/- 5 days) average area under the curve (AUC) for select MD Anderson Symptom Inventory for head and neck cancer (MDASI-HNC) symptoms namely fatigue, pain, sleep disturbance, difficulty swallowing and lack of appetite reported in the symptom survey. Each item is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine). Higher values represent a worse outcome.

  Up to 7 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Twice Daily Orally

Drug: Placebo

Minocycline

EXPERIMENTAL

100 mg Twice Daily Orally

Drug: Minocycline

Interventions

Minocycline DRUG

100 mg twice daily (200 mg) by mouth , every day for 7 weeks starting first day of radiation therapy.

Also known as: Dynacin, Minocin, Minocin PAC, Myrac, Solodyn

Minocycline

Placebo DRUG

Twice daily by mouth, every day for 7 weeks starting at first day of radiation therapy.

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Oropharyngeal Neoplasms; cyclopia sequence

Interventions

Minocycline; Sugars

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Brandon Gunn, MD/ Associate Professor, Radiation Oncology Department
• Organization: UT MD Anderson Cancer Center

gbgunn@mdanderson.org

(713) 563-2562

Study Officials

• Gary B. Gunn, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 2, 2010
• Study Start: July 22, 2010
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: August 20, 2021
• Results First Posted: August 20, 2021

Record last verified: 2021-08

Locations

US (1)