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Trial record 34 of 80 for:    "curcumin" and "cancer"

Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT01048983
Recruitment Status : Withdrawn (No accrual.)
First Posted : January 14, 2010
Last Update Posted : March 5, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

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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 related topics: Lung Cancer

Arm Intervention/treatment
Questionnaires and Phone Calls
Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
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:
  • Nuvigil
  • Modafinil

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:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn

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:
  • Wellbutrin
  • Wellbutrin SR
  • Zyban

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:
  • Nuvigil
  • Modafinil

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:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn

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:
  • Wellbutrin
  • Wellbutrin SR
  • Zyban

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:
  • Nuvigil
  • Modafinil

Drug: Minocycline
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn

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:
  • Nuvigil
  • Modafinil

Drug: Bupropion
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
  • Wellbutrin
  • Wellbutrin SR
  • Zyban

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:
  • Wellbutrin
  • Wellbutrin SR
  • Zyban

Drug: Minocycline
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn

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:
  • Nuvigil
  • Modafinil

Drug: Minocycline
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn

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:
  • Nuvigil
  • Modafinil

Drug: Bupropion
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
  • Wellbutrin
  • Wellbutrin SR
  • Zyban

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:
  • Wellbutrin
  • Wellbutrin SR
  • Zyban

Drug: Minocycline
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn

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:
  • Nuvigil
  • Modafinil

Drug: Bupropion
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
  • Wellbutrin
  • Wellbutrin SR
  • Zyban

Drug: Minocycline
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn

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:
  • Nuvigil
  • Modafinil

Drug: Bupropion
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
  • Wellbutrin
  • Wellbutrin SR
  • Zyban

Drug: Minocycline
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn

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 :
  1. Combined AUC for Selected Symptoms [ Time Frame: 10-weeks (+/- 4 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. 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).
  2. Patients >= 18 years old and <= 65 years old
  3. 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
  4. Patients who speak English only (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol)
  5. Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol
  6. Patients must be willing and able to review, understand, and provide written consent before starting therapy
  7. 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:

  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 taking CHANTIX (smoking cessation medication)
  3. Patients who are enrolled in other symptom management or treatment clinical trials
  4. Bile duct obstruction or cholelithiasis
  5. History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction
  6. Pre-existing psychosis or bipolar disorder
  7. Pre-existing renal impairment: The screening cut off for serum creatinine >1.5mg/dl will be done by the oncologist to qualify for CXRT.
  8. 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.
  9. Pre-existing Tourette's syndrome
  10. Seizure disorder
  11. Anorexia/bulimia in past two months
  12. Use of monoamine oxidase (MAO) inhibitors within 14 days
  13. Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)
  14. Patients receiving other dosage forms of bupropion if they do not agree to undergo a washout period
  15. Allergy to turmeric or any of its constituents, including curcumin, to yellow food coloring, or to member of the Zingiberaceae (ginger) family
  16. Gastric or duodenal ulcers, or gastric hyperacidity disorders
  17. Hypersensitivity to any tetracyclines
  18. Patients to be confirmed as not pregnant (serum HCG negative). The screening for this will be done by the oncologist in qualifying for CXRT.
  19. Patients with a history of cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.
  20. Patients taking antifungals, antiretrovirals, and macrolides that are strong CYP3A4 strong inhibitors including indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, and nefazodone.
  21. Patients on anticoagulants (ie warfarin/heparin)
  22. 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
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Study Chair: Zhongxing Liao, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01048983     History of Changes
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:
Lung Cancer
Curcumin
NSCLC
Concurrent Chemoradiation Therapy
Side Effects
Armodafinil
Nuvigil
Bupropion
Wellbutrin
Wellbutrin SR
Zyban
Minocycline
Dynacin
Minocin
Minocin PAC
Myrac
Solodyn
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Curcumin
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Minocycline
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