Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer

NCT02055963 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2013-0510R01CA026582NCI-2014-01979
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if Minocin® (minocycline) can reduce certain side effects of surgery in patients with head and neck cancer (such as pain, fatigue, and disturbed sleep). In this study, minocycline will be compared to a placebo. A placebo is not a drug. It looks like the study drug, but it is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Conditions

Head And Neck Cancer

Keywords

Head And Neck Cancer; Postsurgical symptom reduction; Minocycline; Dynacin; Minocin; Minocin PAC; Myrac; Solodyn; Placebo; Sugar pill; Questionnaires; Surveys

Outcome Measures

Primary Outcomes (1)

• Efficacy of Minocycline for Reducing Patient-Reported Symptoms

  Primary outcome variable is area under the curve (AUC) using the average of the 3 most severe symptoms (pain, fatigue, and disturbed sleep) beginning 2 days prior to surgery and ending 21 days postsurgery. AUC calculated using trapezoidal approximation. The base of a trapezoid corresponds to the number of days between assessments while the heights correspond to 2 adjoining symptom responses. The number of trapezoids depends on the number of symptom assessments. The sum of the area for all the trapezoids represents the AUC of a particular patient. Data were collected to create the curve (-2, 0, 1, 3, 5, 7, 10, 14, 17, and 21 days post-dose)

  -2 to 21 days post-dose

Secondary Outcomes (1)

• Number of Participants Time-to-Symptom-Recovery

  Day -2, Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, Day 20

Study Arms (2)

Minocycline

EXPERIMENTAL

Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery. Minocycline100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery. Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.

Drug: Minocycline; Behavioral: Questionnaires

Placebo

PLACEBO COMPARATOR

Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery. Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery). Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.

Drug: Placebo; Behavioral: Questionnaires

Interventions

Minocycline DRUG

100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.

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

Minocycline

Placebo DRUG

Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.

Also known as: Sugar pill

Placebo

Questionnaires BEHAVIORAL

Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.

Also known as: Surveys

Minocycline; 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 head and neck cancer who are undergoing either flap or nonflap surgery (limited to parotidectomy, hard palate maxillectomy and glossectomy, mandibulectomy, and any procedure with neck dissection) at MD Anderson Cancer Center.
• Patients \> 18 years old.
• Patients who have not undergone surgery in the past 6 months. Patients may have had neoadjuvant chemotherapy prior to surgery.
• Patients must have normal renal function test and no prior renal disease. The screening cut off for serum creatinine is \< 1.5mg/dL.
• Patients must have normal hepatic function test and no prior liver disease: (1) The screening results for alanine aminotransferase (ALT) must be \< 2 times the upper limit of normal. (2) The screening results for aspartate aminotransferase (AST), if available, must be \< 2 times the upper limit of normal.
• Patients who speak English or Spanish (due to the novel research and its complexity, we are only accruing English-speaking or Spanish-speaking patients to the protocol).
• Patients must be willing and able to review, understand, and provide written consent.
• Patients must be willing to discontinue taking dong quai and/or St. John's wort.

You may not qualify if:

• Patients who are taking medications (including minocycline) or have conditions that potentially preclude use of the study medication or intervention as determined by the treating physician.
• Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial.
• Patients with a history of clinically significant cutaneous drug reaction, hypersensitivity reaction, anaphylaxis or any other serious adverse reaction to any of the anesthetics or analgesics medications used in the study.
• Patients with hypersensitivity to any tetracycline.
• Patients on vitamin K antagonist (i.e., warfarin).
• Patients taking any tetracycline within the last 15 days.
• Patients who have been on opioid therapy for the last 4 weeks or more.
• Patients with bile duct obstruction.
• Patients who are pregnant.
• Patients with INR \> 1.5.
• Patients with autoimmune disease.

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

Head and Neck Neoplasms; cyclopia sequence

Interventions

Minocycline; Sugars; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Carbohydrates; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

Early termination due to the protocol lack of progress in improving accrual rate.

Results Point of Contact

• Title: Dr. Juan P. Cata, MD-Associate Professor, Anesthesiology & PeriOper Med
• Organization: UT MD Anderson Cancer Center

jcata@mdanderson.org

(713) 792-7452

Study Officials

• Juan P. Cata, 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: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: May 6, 2014
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: October 20, 2022
• Results First Posted: October 18, 2022

Record last verified: 2022-10

Locations

US (1)