A Pilot Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Pilot Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer
The Study Drugs:
Armodafinil is designed to prevent excessive sleepiness.
Minocycline is an antibiotic. Minocycline has been shown to interrupt cytokine production,
which may help to reduce multiple symptoms.
A placebo is not a drug. It looks like the study drug but 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.
Study Groups:
If patient agrees to take part in this study, they will be randomly assigned (as in the roll
of dice) to join 1 of 4 groups.
- Group 1 will take armodafinil and a placebo.
- Group 2 will take minocycline and a placebo.
- Group 3 will take armodafinil and minocycline.
- Group 4 will take placebos alone.
Neither patient nor the study staff patient will see in the clinic will know if they are
receiving the study drug(s) and/or the placebo(s). However, if needed for patient's safety,
the study staff will be able to find out which study drug they are receiving.
If needed, during this study, patient may receive standard care by their treating doctors.
Study Drug Administration:
Patient will take the study drug(s)/placebos every day for 10 weeks. Patient should take the
drug(s)/placebo(s) with a full glass of water. If patient gets an upset stomach, take them
with food.
Patient will be given pamphlets with more information about how to take the study
drugs/placebos.
Patient should bring their study drug/placebo capsules to the clinic every study visit.
Completing the Symptom Questionnaire:
Throughout the study, patient will be asked to complete the symptom questionnaire. Patient
will be asked about symptoms from therapy they may be experiencing and how they may be
interfering with their daily activities. The study staff will either meet patient during
their regular clinic visit or call patient at their home at a time that is convenient for
the patient. In the clinic, patient will complete the questionnaire by paper and pen, or by
entering their answers into an electronic tablet computer. On the phone, study staff will
ask patient the questions and record their answers on paper or enter them into a computer.
Patient will complete the symptom questionnaire before they begin chemoradiation and then 1
time a week during Weeks 1-16 of the study. The symptom questionnaire will take up to 5
minutes to complete.
Study Visits:
Before patient begins chemoradiation:
- Patient will complete 4 questionnaires about pain and other symptoms, their mood, and
their quality of life. Completing all 4 of the questionnaires will take about 15
minutes.
- If patient is able to become pregnant, they will have a urine pregnancy test. The study
staff will give patient the pregnancy test kit at their scheduled visit, and will
review and record the results of the test before patient can pick up the study drugs
from the pharmacy.
During the last week of chemoradiation (about Week 7):
-Patient will complete 3 questionnaires about their symptoms, mood, and quality of life.
These questionnaires will take about 10 minutes total to complete.
After about Week 7, the study staff will call patient 1 time a week to check on patient
until Week 10. This phone call should last only a few minutes. If patient has had several
side effects from chemoradiation, this phone call may take longer.
About Week 12 (at a routine clinical visit):
- Patient will complete the 3 questionnaires about their symptoms, mood, and quality of
life.
- If patient was smoking at the beginning of the study, they will complete a
questionnaire that asks if they stopped smoking any time during the study. This will
take a few minutes to complete.
- Patient will be asked to complete another questionnaire that asks about their
satisfaction with the study drug(s). This will take a few minutes.
Length of Study:
Patient will be on study for about 16 weeks. Patient will take the study drug(s) for 10
weeks and complete the symptom survey until Week 16. Patient will be taken off study early
if they have intolerable side effects.
This is an investigational study. Armodafinil is FDA approved and commercially available
for the treatment of excessive sleepiness. Minocycline is FDA approved and commercially
available for the treatment of bacterial infections. The use of these drugs to help reduce
chemoradiation symptoms is investigational.
Up to 12 patients will take part in this study. All will be enrolled at MD Anderson.
Inclusion Criteria:
1. Patients with a pathologically proven diagnosis of NSCLC and consented to concurrent
chemoradiation therapy at MD Anderson.
2. Patients > or =18 years old
3. Patients who will receive chemoradiation with platinum/taxane-based chemotherapy and
with a total radiation dose of > 50 Gy, per treating physician's assessment
4. 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)
5. Patients must be willing and able to review, understand, and provide written consent
before starting therapy
Exclusion Criteria:
1. Patients who are taking medications or have conditions that potentially preclude use
of any study medications or interventions, as determined by the treating physician
2. Patients who are enrolled in other symptom management or treatment clinical trials
3. Patients currently taking methylphenidate and/or dextroamphetamine.
4. 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
5. Patients with pre-existing psychosis or bipolar disorder.
6. Patients with pre-existing renal impairment: The screening cut off for serum
creatinine >1.5 times ULN, according to MD Anderson testing standards, will be done
by the oncologist to qualify for CXRT.
7. 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.
8. Patients with pre-existing Tourette's syndrome.
9. Patients with hypersensitivity to any tetracyclines.
10. 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
11. 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 CNS stimulant use .
12. 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) .
13. Patients on vitamin K antagonist warfarin.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
10-week AUC for 5 targeted symptoms
Outcome Description:
Estimates of treatment effects and the variability of these estimates using a 10-week (+/- 2 days) area under the curve (AUC) for 5 targeted symptoms: fatigue, pain, disturbed sleep, lack of appetite, and drowsiness, either as a combination or individually. Baseline assessments within 2 days of start of CXRT, while symptom intervention agents start day of CXRT or within 2 days of the start of CXRT.
Outcome Time Frame:
10 weeks
Safety Issue:
No
Principal Investigator
Zhongxing Liao, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2010-0872
NCT ID:
NCT01317550
Start Date:
July 2011
Completion Date:
Related Keywords:
- Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
