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Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer

NCT02055963 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-10-20

Study results available
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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

Interventions

DRUG

Minocycline

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

DRUG

Placebo

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

BEHAVIORAL

Questionnaires

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Juan P. Cata, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-06
Primary Completion
2022-08-11
Completion
2022-08-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02055963 on ClinicalTrials.gov