NCT02055963

Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer

Terminated Phase 2 Results posted Last updated 20 October 2022

What this trial tests

Phase 2 trial testing Minocycline in Head And Neck Cancer in 30 participants. Terminated before completion.

Timeline

6 May 2014

Primary endpoint
11 August 2022

11 August 2022

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	30
Start date	6 May 2014
Primary completion	11 August 2022
Estimated completion	11 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Minocycline (MINOCYCLINE) — full drug profile →
• Placebo
• Questionnaires

Conditions studied

• Head And Neck Cancer — all drugs for Head And Neck Cancer →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Head And Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Efficacy of Minocycline for Reducing Patient-Reported Symptoms Primary · -2 to 21 days post-dose

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,

Group	Value	95% CI
Minocycline	66.4	± 32.4
Placebo	67.5	± 38.2

Number of Participants Time-to-Symptom-Recovery Secondary · Day -2, Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, Day 20

Time-to-symptom-recovery defined to be the time it takes for symptom severity (average of pain, fatigue and disturbed sleep) to return to preoperative levels for 2 consecutive assessments. Repeated measures ANOVA performed with group (minocycline vs. placebo), time (presurgery, postsurgery, discharge, follow up) and group-by-time interaction as factors and proinflammatory cytokine level as a dependent variable. Data measured at Day -2, Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, Day 20. Cox proportional hazards models were used to explore predictors of time-to-symptom-recovery.

Day -2

Group	Value	95% CI
Minocycline	12
Placebo	14

Day 0

Group	Value	95% CI
Minocycline	6
Placebo	13

Day 1

Group	Value	95% CI
Minocycline	11
Placebo	14

Day 3

Group	Value	95% CI
Minocycline	10
Placebo	13

Day 5

Group	Value	95% CI
Minocycline	9
Placebo	14

Day 7

Group	Value	95% CI
Minocycline	10
Placebo	12

Day 10

Group	Value	95% CI
Minocycline	11
Placebo	12

Day 14

Group	Value	95% CI
Minocycline	12
Placebo	14

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone). Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Minocycline

Serious: 0/14 (0%)

Deaths: 0/14

Placebo

Serious: 1/16 (6%)

Deaths: 0/16

Serious adverse events (1 terms)

Reaction	System	Minocycline	Placebo
Stroke	Nervous system disorders	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Minocycline	Placebo
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Hives	Skin and subcutaneous tissue disorders	—	—
Itchy	Skin and subcutaneous tissue disorders	—	—
Lack of appetite	Gastrointestinal disorders	—	—

Most-reported serious reactions: Stroke.

Data from ClinicalTrials.gov NCT02055963 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Repurposing of Antimicrobial Agents for Cancer Therapy: What Do We Know?
   Pfab C, Schnobrich L, Eldnasoury S, Gessner A, et al · · 2021 · cited 53× · PMID 34206772 · DOI 10.3390/cancers13133193
2. Mechanism-informed Repurposing of Minocycline Overcomes Resistance to Topoisomerase Inhibition for Peritoneal Carcinomatosis.
   Huang HC, Liu J, Baglo Y, Rizvi I, et al · · 2018 · cited 27× · PMID 29167313 · DOI 10.1158/1535-7163.mct-17-0568
3. Minocycline and photodynamic priming significantly improve chemotherapy efficacy in heterotypic spheroids of pancreatic ductal adenocarcinoma.
   Bano S, Alburquerque JQ, Roberts HJ, Pang S, et al · · 2024 · cited 7× · PMID 38663337 · DOI 10.1016/j.jphotobiol.2024.112910