Trial Outcomes & Findings for Symptom Burden in Head and Neck Cancer (NCT NCT01219673)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

10 weeks

Results posted on

2015-02-10

Participant Flow

Recruitment Period: March 21, 2013 to June 25, 2013. All recruitment occurred at The University of Texas (UT) MD Anderson Cancer Center.

Due to study design changes and restrictive eligibility criteria, study enrollment was low therefore study terminated early with only one participant enrolled.

Participant milestones

Participant milestones
Measure	Placebo Placebo by mouth 2 times every day. Placebo: 1 by mouth twice a day.	Armodafinil Armodafinil 150 mg by mouth once a day. Armodafinil: 150 mg by mouth once a day.	Minocycline Minocycline 100 mg by muth two times a day. Minocycline: 100 mg by mouth twice a day.	Bupropion Bupropion 100 mg by mouth two times a day. Bupropion: 100 mg by mouth twice a day.	Armodafinil + Minocycline Armodafinil 150 mg by mouth once a day. Minocycline 100 mg by mouth two times a day. Armodafinil: 150 mg by mouth once a day. Minocycline: 100 mg by mouth twice a day.	Armodafinil + Bupropion Armodafinil 150 mg by mouth once a day. Bupropion 100 mg by mouth two times a day. Armodafinil: 150 mg by mouth once a day. Bupropion: 100 mg by mouth twice a day.	Minocycline + Bupropion Minocycline 100 mg by muth two times a day. Bupropion 100 mg by mouth two times a day. Minocycline: 100 mg by mouth twice a day. Bupropion: 100 mg by mouth twice a day.	Armodafinil + Minocycline + Bupropion Armodafinil 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. Armodafinil: 150 mg by mouth once a day. Minocycline: 100 mg by mouth twice a day. Bupropion: 100 mg by mouth twice a day.
Overall Study STARTED	0	0	1	0	0	0	0	0
Overall Study COMPLETED	0	0	1	0	0	0	0	0
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Symptom Burden in Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Placebo by mouth 2 times every day. Placebo: 1 by mouth twice a day.	Armodafinil Armodafinil 150 mg by mouth once a day. Armodafinil: 150 mg by mouth once a day.	Minocycline n=1 Participants Minocycline 100 mg by muth two times a day. Minocycline: 100 mg by mouth twice a day.	Bupropion Bupropion 100 mg by mouth two times a day. Bupropion: 100 mg by mouth twice a day.	Armodafinil + Minocycline Armodafinil 150 mg by mouth once a day. Minocycline 100 mg by mouth two times a day. Armodafinil: 150 mg by mouth once a day. Minocycline: 100 mg by mouth twice a day.	Armodafinil + Bupropion Armodafinil 150 mg by mouth once a day. Bupropion 100 mg by mouth two times a day. Armodafinil: 150 mg by mouth once a day. Bupropion: 100 mg by mouth twice a day.	Minocycline + Bupropion Minocycline 100 mg by muth two times a day. Bupropion 100 mg by mouth two times a day. Minocycline: 100 mg by mouth twice a day. Bupropion: 100 mg by mouth twice a day.	Armodafinil + Minocycline + Bupropion Armodafinil 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. Armodafinil: 150 mg by mouth once a day. Minocycline: 100 mg by mouth twice a day. Bupropion: 100 mg by mouth twice a day.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	—	0 participants n=5 Participants	—	—	—	—	—	0 participants n=42 Participants
Age, Categorical Between 18 and 65 years	—	—	1 participants n=5 Participants	—	—	—	—	—	1 participants n=42 Participants
Age, Categorical >=65 years	—	—	0 participants n=5 Participants	—	—	—	—	—	0 participants n=42 Participants
Gender Female	—	—	0 participants n=5 Participants	—	—	—	—	—	0 participants n=42 Participants
Gender Male	—	—	1 participants n=5 Participants	—	—	—	—	—	1 participants n=42 Participants
Region of Enrollment United States	—	—	1 participants n=5 Participants	—	—	—	—	—	1 participants n=42 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: No analysis was completed. Study terminated with low enrollment.

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.

Outcome measures

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Rosenthal Professor, Radiation Oncology Department

University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place