TriangleNCT01219673 · OUTCOME
Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- 10 weeks
What was measured
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.
Analysis population: No analysis was completed. Study terminated with low enrollment.
Groups in this outcome
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.
| Group | Source count |
|---|---|
| Placebo | 0 |
| Armodafinil | 0 |
| Minocycline | 0 |
| Bupropion | 0 |
| Armodafinil + Minocycline | 0 |
| Armodafinil + Bupropion | 0 |
| Minocycline + Bupropion | 0 |
| Armodafinil + Minocycline + Bupropion | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- units
- Participants
- description
- 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.
- groups
- description
- Placebo by mouth 2 times every day. Placebo: 1 by mouth twice a day.
- id
- OG000
- title
- Placebo
- description
- Armodafinil 150 mg by mouth once a day. Armodafinil: 150 mg by mouth once a day.
- id
- OG001
- title
- Armodafinil
- description
- Minocycline 100 mg by muth two times a day. Minocycline: 100 mg by mouth twice a day.
- id
- OG002
- title
- Minocycline
- description
- Bupropion 100 mg by mouth two times a day. Bupropion: 100 mg by mouth twice a day.
- id
- OG003
- title
- Bupropion
- description
- 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.
- id
- OG004
- title
- Armodafinil + Minocycline
- description
- 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.
- id
- OG005
- title
- Armodafinil + Bupropion
- description
- 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.
- id
- OG006
- title
- Minocycline + Bupropion
- description
- 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.
- id
- OG007
- title
- Armodafinil + Minocycline + Bupropion
- population Description
- No analysis was completed. Study terminated with low enrollment.
- reporting Status
- POSTED
- time Frame
- 10 weeks
- title
- Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores)
- type
- PRIMARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice