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NCT01930435 · ClinicalTrials.gov registry record · NA
Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients
A NA study of Head and Neck Cancer, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01930435: Completed NA study of Head and Neck Cancer, sponsored by University of California, San Francisco.
NCT01930435 is a NA study of Head and Neck Cancer that has completed, run by University of California, San Francisco. The registered enrollment target is 20 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01930435, a NA study of Head and Neck Cancer, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single arm study of the use of a personalized sterile humidification device for 12 weeks for head and neck cancer patients undergoing radiation therapy to determine if the usage of this humidification system will result in a decrease in severity in head and neck related quality of life as measured by the MDASI HN subscale following radiation therapy as compared with historical experience. In addition, we are exploring correlative measures using CRP, IL-1, IL-6, and TNF-alpha level measurements as these are directly related to mucositis and presumably related to quality of life as indicated by the patient.
Primary Outcome
The MDASI-HN assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 NRS, with 0 being "not present" and 10 being "as bad as you can imagine." There are 28 items in the MDASI-HN. There are 13 general inventory items, 6 general interference items, and the HN subscale adds 9 additional items assessing mucus in the mouth and throat, difficulty swallowing/chewing, choking/coughing, difficulty with voice/speech, skin pain/burning/rash, constipation, problems with tasting food,
Conditions Studied
Interventions
- DEVICE Sterile Humidification Device
Study Locations (1)
California
- Helen Diller Family Comprehensive Center, UCSF - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-08 |
| Phase | NA |
What the finished NCT01930435 record still lists
NCT01930435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Sterile Humidification Device is the first listed.
NCT01930435 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01930435 about?
NCT01930435 is a clinical study titled "Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients". This is a single arm study of the use of a personalized sterile humidification device for 12 weeks for head and neck cancer patients undergoing radiation therapy to determine if the usage of this humidification system will result in a decrease in severity in head and neck related quality of life as ...
What is the current status of trial NCT01930435?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2013-07. Estimated completion is 2014-08.
What conditions does trial NCT01930435 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT01930435?
The interventions under investigation include: Sterile Humidification Device (DEVICE).
Who is sponsoring clinical trial NCT01930435?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01930435 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01930435's enrollment target sits among peer trials
20 219th of 250 higher than 29 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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