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

This study is not yet open for participant recruitment.
Verified on July 2011 by M.D. Anderson Cancer Center

First Received on January 12, 2010.  
Last Updated on July 26, 2011  
History of Changes
This Clinical Trial Sponsored By: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01048983
 

Purpose for Clinical Trial

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 Study Intervention Clinical Trial Phase
Non Small Cell Lung Cancer Drug: Armodafinil
Drug: Bupropion
Drug: Minocycline
Drug: Curcumin
Behavioral: Telephone Questionnaire
Phase I
Phase II

Study Type: Study Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 NLM:

MedlinePlus related topics:
Cancer
Lung Cancer
Drug Information available for:
Minocycline
Minocycline hydrochloride
Bupropion hydrochloride
Bupropion
Modafinil
Armodafinil
Curcumin

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures For Clinical Trial:

  • Combined AUC for Selected Symptoms [ Time Frame: 10-weeks (+/- 4 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: October 2011
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

No Study Intervention: No Study Intervention

Study Intervention: Behavioral: Telephone Questionnaire
Behavioral: Telephone Questionnaire

Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
Other Name: Survey
Curcumin Only: Active Comparator

Study Interventions:
  • Drug: Curcumin
  • Behavioral: Telephone Questionnaire
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
Armodafinil Only: Active Comparator

Study Interventions:
  • Drug: Armodafinil
  • Behavioral: Telephone Questionnaire
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
Minocycline Only: Active Comparator

Study Interventions:
  • Drug: Minocycline
  • Behavioral: Telephone Questionnaire
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
Bupropion Only: Active Comparator

Study Interventions:
  • Drug: Bupropion
  • Behavioral: Telephone Questionnaire
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
Curcumin + Armodafinil: Active Comparator

Study Interventions:
  • Drug: Armodafinil
  • Drug: Curcumin
  • Behavioral: Telephone Questionnaire
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
Curcumin + Minocycline: Active Comparator

Study Interventions:
  • Drug: Minocycline
  • Drug: Curcumin
  • Behavioral: Telephone Questionnaire
Drug: Minocycline

Initial Dose 100 mg two times a day (200 mg) for 10 weeks.

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