A Study for Reducing Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer by Minocycline and Armodafinil

NCT01317550 | Completed Results DMC

• 3 other identifiers: 2010-0872R01 026582-26NCI-2011-00778
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.

Conditions

Lung Cancer

Keywords

Non-Small Cell Lung Cancer; NSCLC; Symptoms; Concurrent Chemoradiation; CXRT; Fatigue; Pain; Disturbed Sleep; Lack of Appetite; Drowsiness; Armodafinil; Nuvigil; Minocycline; Dynacin; Minocin; Minocin PAC; Myrac; Solodyn; Placebo

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness

  Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0\*70) to 700 (10\*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.

  During 10 weeks of CXRT

Study Arms (4)

Armodafinil + Placebo

EXPERIMENTAL

Armodafinil orally 150 mg/day + Placebo capsules for 10 weeks

Drug: Armodafinil; Other: Placebo; Behavioral: Questionnaires

Minocycline + Placebo

EXPERIMENTAL

Minocycline orally 100 mg twice/day + Placebo capsules for 10 weeks

Other: Placebo; Drug: Minocycline; Behavioral: Questionnaires

Armodafinil + Minocycline

EXPERIMENTAL

Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks

Drug: Armodafinil; Drug: Minocycline; Behavioral: Questionnaires

Placebos

PLACEBO COMPARATOR

Placebo Capsules orally once/day for 10 weeks

Other: Placebo; Behavioral: Questionnaires

Interventions

Armodafinil DRUG

150 mg by mouth once a day for a 10 week cycle.

Also known as: Nuvigil

Armodafinil + Minocycline; Armodafinil + Placebo

Placebo OTHER

Capsules taken by mouth once a day for a 10 week cycle.

Also known as: Sugar Pill

Armodafinil + Placebo; Minocycline + Placebo; Placebos

Minocycline DRUG

100 mg by mouth twice a day for a 10 week cycle.

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

Armodafinil + Minocycline; Minocycline + Placebo

Questionnaires BEHAVIORAL

Completion of symptom questionnaire before chemoradiation, then once a week during Weeks 1-16, takes up to 5 minutes to complete.

Also known as: Surveys

Armodafinil + Minocycline; Armodafinil + Placebo; Minocycline + Placebo; Placebos

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 NSCLC and consented to concurrent chemoradiation therapy at MD Anderson.
• Patients \> or =18 years old
• Patients who will receive chemoradiation with platinum/taxane-based chemotherapy and with a total radiation dose of \> 50 Gy, per treating physician's assessment
• Patients who speak English or Spanish (due to the novel research and its complexity, we are only accruing English or Spanish-speaking patients to the protocol)
• Patients must be willing and able to review, understand, and provide written consent before starting therapy

You may not qualify if:

• 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 other symptom management or treatment clinical trials
• Patients currently taking methylphenidate and/or dextroamphetamine.
• Patients with a history of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction as documented in the patient medical records
• Patients with pre-existing psychosis or bipolar disorder.
• Patients with pre-existing renal impairment: The screening cut off for serum creatinine \>1.5 times upper limits of normal (ULN), according to MD Anderson testing standards, will be done by the oncologist to qualify for CXRT.
• Patients with pre-existing hepatic impairment: The screening for total bilirubin \>1.5 times ULN will be done by the oncologist to qualify for CXRT. The screening for \> 2 times the upper limit of normal hepatotoxicity, alkaline phosphatase (ALP) and alanine aminotransferase (ALT) (and aspartate aminotransferase \[AST\] if it is ordered and available in the medical records) will be done by the oncologist to qualify for CXRT.
• Patients with pre-existing Tourette's syndrome.
• Patients with hypersensitivity to any tetracyclines.
• Patients who are pregnant. Pregnancy will be confirmed by negative urine test. Study staff will provide the pregnancy kits to women and make sure the results are known and recorded in the follow-up notes in Clinic Station before additional study drug prescriptions are filled by the Pharmacy
• Patients with uncontrolled cardiac disease, within the past six months history of left ventricular hypertrophy, myocardial infarction, and history of mitral valve prolapse syndrome with previous central nervous system (CNS) stimulant use.
• Patients taking medicines that are strong CYP3A4 inhibitors or inducers (including conivaptan, indinavir, nelfinavir, ritonavir, nefazodone, and phenytoin), or strong CYP2C19 inhibitors (including citalopram and clopidogrel) .
• Patients on vitamin K antagonist warfarin.

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

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Fatigue; Pain; Parasomnias; Anorexia; Sleepiness; cyclopia sequence

Interventions

Modafinil; Sugars; Minocycline; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Zhongxing Liao, MD/Professor, Radiation Oncology Department
• Organization: MD Anderson Cancer Center

zliao@mdanderson.org

713-563-2300

Study Officials

• Zhongxing Liao, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: March 17, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-01

Locations

US (1)