Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)
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| ClinicalTrials.gov Identifier: NCT01048983 |
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Recruitment Status :
Withdrawn
(No accrual.)
First Posted : January 14, 2010
Last Update Posted : March 5, 2015
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Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
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Brief Summary:
The goal of this clinical research study is to compare armodafinil, bupropion, curcumin, 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Small Cell Lung Cancer | Drug: Armodafinil Drug: Bupropion Drug: Minocycline Drug: Curcumin Behavioral: Telephone Questionnaire | Phase 1 Phase 2 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
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Questionnaires and Phone Calls
Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
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Behavioral: Telephone Questionnaire
Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Curcumin Only |
Drug: Curcumin
Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks. Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Armodafinil Only |
Drug: Armodafinil
Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.
Other Names:
Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Minocycline Only |
Drug: Minocycline
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Bupropion Only |
Drug: Bupropion
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Curcumin + Armodafinil |
Drug: Armodafinil
Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.
Other Names:
Drug: Curcumin Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks. Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Curcumin + Minocycline |
Drug: Minocycline
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Drug: Curcumin Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks. Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Curcumin + Bupropion |
Drug: Bupropion
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Drug: Curcumin Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks. Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Armodafinil + Minocycline |
Drug: Armodafinil
Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.
Other Names:
Drug: Minocycline Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Armodafinil + Bupropion |
Drug: Armodafinil
Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.
Other Names:
Drug: Bupropion Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Minocycline + Buproprion |
Drug: Bupropion
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Drug: Minocycline Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Curcumin + Armodafinil + Minocycline |
Drug: Armodafinil
Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.
Other Names:
Drug: Minocycline Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Drug: Curcumin Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks. Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Curcumin + Armodafinil + Bupropion |
Drug: Armodafinil
Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.
Other Names:
Drug: Bupropion Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Drug: Curcumin Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks. Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Curcumin + Minocycline + Bupropion |
Drug: Bupropion
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Drug: Minocycline Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Drug: Curcumin Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks. Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Armodafinil + Minocycline + Bupropion |
Drug: Armodafinil
Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.
Other Names:
Drug: Bupropion Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Drug: Minocycline Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
| Active Comparator: Curcumin + Armodafinil + Minocycline + Bupropion |
Drug: Armodafinil
Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.
Other Names:
Drug: Bupropion Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Drug: Minocycline Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
Drug: Curcumin Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks. Behavioral: Telephone Questionnaire Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey |
Primary Outcome Measures :
- Combined AUC for Selected Symptoms [ Time Frame: 10-weeks (+/- 4 days) ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with a pathologically proven diagnosis of unresectable Non-small-cell lung carcinoma (NSCLC) and consented to concurrent chemoradiation therapy in MD Anderson Cancer Center (MDACC).
- Patients >= 18 years old and <= 65 years old
- Patients who will receive chemoradiation with platinum/taxane based chemo and with a total radiation dose of > or = 50 Gy, per treating physician's assessment
- Patients who speak English only (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol)
- Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol
- Patients must be willing and able to review, understand, and provide written consent before starting therapy
- Patients already taking any of this trial's symptom treatment medications (including modafinil) must be willing to stop taking the medication/s for a washout period of 30 days before they are randomized to a symptom treatment arm and begin the symptom trial
Exclusion Criteria:
- 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 taking CHANTIX (smoking cessation medication)
- Patients who are enrolled in other symptom management or treatment clinical trials
- Bile duct obstruction or cholelithiasis
- History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction
- Pre-existing psychosis or bipolar disorder
- Pre-existing renal impairment: The screening cut off for serum creatinine >1.5mg/dl will be done by the oncologist to qualify for CXRT.
- Pre-existing hepatic impairment: The screening for total bilirubin >25.7 µmol/L (1.5 mg/dL) will be done by the oncologist to qualify for chemoradiation treatment (CXRT). The screening for 2 times the upper limit of normal Hepatotoxicity (Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT) will be done by the oncologist to qualify for CXRT.
- Pre-existing Tourette's syndrome
- Seizure disorder
- Anorexia/bulimia in past two months
- Use of monoamine oxidase (MAO) inhibitors within 14 days
- Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)
- Patients receiving other dosage forms of bupropion if they do not agree to undergo a washout period
- Allergy to turmeric or any of its constituents, including curcumin, to yellow food coloring, or to member of the Zingiberaceae (ginger) family
- Gastric or duodenal ulcers, or gastric hyperacidity disorders
- Hypersensitivity to any tetracyclines
- Patients to be confirmed as not pregnant (serum HCG negative). The screening for this will be done by the oncologist in qualifying for CXRT.
- Patients with a history of cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.
- Patients taking antifungals, antiretrovirals, and macrolides that are strong CYP3A4 strong inhibitors including indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, and nefazodone.
- Patients on anticoagulants (ie warfarin/heparin)
- Patients with International Normalized Ratio (INR) > 1.5.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048983
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Study Chair: | Zhongxing Liao, MD | M.D. Anderson Cancer Center |
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01048983 |
| Other Study ID Numbers: |
2008-0345 R01 026582-26 ( Other Identifier: NCI ) NCI-2012-01256 ( Registry Identifier: NCI CTRP ) |
| First Posted: | January 14, 2010 Key Record Dates |
| Last Update Posted: | March 5, 2015 |
| Last Verified: | March 2015 |
Keywords provided by M.D. Anderson Cancer Center:
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Lung Cancer NSCLC Concurrent Chemoradiation Therapy Side Effects Armodafinil Nuvigil Bupropion Wellbutrin Wellbutrin SR |
Zyban Curcumin Minocycline Dynacin Minocin Minocin PAC Myrac Solodyn |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Minocycline Curcumin Modafinil Bupropion Antidepressive Agents, Second-Generation |
Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Anti-Bacterial Agents Anti-Infective Agents Anti-Inflammatory Agents, Non-Steroidal |