Study Stopped
Low accrual.
Symptom Burden in Head and Neck Cancer
A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Head and Neck Cancer
2 other identifiers
interventional
1
1 country
1
Brief Summary
The goal of this clinical research study is to compare armodafinil, bupropion, and minocycline when given alone or in combination. Researchers want to learn about the safety and level of effectiveness of these drugs in controlling symptoms, such as the side effects of chemoradiation, when given to patients with head and neck cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 head-and-neck-cancer
Started Mar 2013
Shorter than P25 for phase_1 head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
February 10, 2015
CompletedFebruary 10, 2015
January 1, 2015
10 months
October 11, 2010
January 15, 2015
January 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores)
Treatments ability to reduce values of 5 symptoms comprised of MD Anderson Symptom Inventory (MDASI)-Head and Neck Cancer (HNC) scores for fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite collected during the 10 weeks of chemoradiation treatment. symptoms that are caused by their disease or by their treatment. Symptom severity score is comprised of average of the five above MDASI core items (fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.
10 weeks
Study Arms (8)
Placebo
PLACEBO COMPARATORPlacebo by mouth 2 times every day.
Armodafinil
EXPERIMENTALArmodafinil 150 mg by mouth once a day.
Minocycline
EXPERIMENTALMinocycline 100 mg by muth two times a day.
Bupropion
EXPERIMENTALBupropion 100 mg by mouth two times a day.
Armodafinil + Minocycline
EXPERIMENTALArmodafinil 150 mg by mouth once a day. Minocycline 100 mg by mouth two times a day.
Armodafinil + Bupropion
EXPERIMENTALArmodafinil 150 mg by mouth once a day. Bupropion 100 mg by mouth two times a day.
Minocycline + Bupropion
EXPERIMENTALMinocycline 100 mg by muth two times a day. Bupropion 100 mg by mouth two times a day.
Armodafinil + Minocycline + Bupropion
EXPERIMENTALArmodafinil 150 mg by mouth once a day. Minocycline 100 mg by muth two times a day. Bupropion 100 mg by mouth two times a day.
Interventions
150 mg by mouth once a day.
100 mg by mouth twice a day.
100 mg by mouth twice a day.
Eligibility Criteria
You may qualify if:
- Patients with a pathologically proven diagnosis of epithelial carcinoma of the oropharynx, nasopharynx, hypopharynx, larynx, or oral cavity being treated at MDACC.
- Patients \>/= 18 years old and \</= 65 years old.
- Patients with the above cancers scheduled to receive definitive concurrent chemoradiation over 6 - 7 weeks.
- Patients who speak English (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.
- Women of childbearing potential (women who are not postmenopausal for at least one year and are not surgically sterile) must have negative urine pregnancy test..
- Sexually active males and females must agree to use birth control or abstinence for the duration of the trial.
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 taking CHANTIX (smoking cessation medication)
- Patients who are enrolled in other symptom management trial or receiving active therapy as part of a treatment clinical trial.
- 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. Patients with major depressive disorder or severe depression (a score of 13 or greater on the BDI Fast Screen (BDI-FS) will be excluded. If this is the case, we will notify their treating physician for appropriate management or referral.
- Pre-existing renal impairment: The screening cut off for serum creatinine \> the upper limit of normal, will be done by the oncologist to qualify for chemoradiation.
- Pre-existing hepatic impairment: The screening for total bilirubin \> 1.5 times the upper limit of normal will be done by the oncologist to qualify for chemoradiation. The screening for \>2 times the upper limit of normal hepatotoxicity: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT) will be done by the oncologist to qualify for chemoradiation.The screening results for Aspartate aminotransferase (AST) must be \< 2 times the upper limit of normal if available in the medical records.
- 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 currently taking any of the study drugs
- Hypersensitivity to any tetracyclines
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Vita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4.
PMID: 36999619DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Analysis was not possible due to early termination with only one participant accrued.
Results Point of Contact
- Title
- Dr. David Rosenthal Professor, Radiation Oncology Department
- Organization
- University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
David I. Rosenthal, MD, MA, BA
UT MD Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2010
First Posted
October 13, 2010
Study Start
March 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
February 10, 2015
Results First Posted
February 10, 2015
Record last verified: 2015-01