Trial Outcomes & Findings for Dynasplint Therapy for Trismus in Head and Neck Cancer (NCT NCT00507208)
NCT ID: NCT00507208
Last Updated: 2016-09-13
Results Overview
Number of participants who demonstrated improved maximal incisial opening (MIO), the distance from the tips of the upper and lower incisors on maximal effort. Successful improvement is defined as \> 5mm improvement from the baseline measurement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
12 months
Results posted on
2016-09-13
Participant Flow
Participant milestones
| Measure |
Dynasplint
Participants randomized to this arm will be treated with the Dynasplint Trismus System
|
Control
Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
Received Dynasplint in Crossover
|
0
|
3
|
|
Overall Study
COMPLETED
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dynasplint Therapy for Trismus in Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Dynasplint
n=27 Participants
Participants randomized to this arm will be treated with the Dynasplint Trismus System
|
Control
n=26 Participants
Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
23 participants
n=5 Participants
|
17 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
3 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Prior Treatment
Chemoradiation & Surgery
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Prior Treatment
Surgery only
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber of participants who demonstrated improved maximal incisial opening (MIO), the distance from the tips of the upper and lower incisors on maximal effort. Successful improvement is defined as \> 5mm improvement from the baseline measurement.
Outcome measures
| Measure |
Dynasplint
n=27 Participants
Participants randomized to this arm will be treated with the Dynasplint Trismus System
|
Control
n=26 Participants
Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
|
|---|---|---|
|
Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors
MIO improvement > 5mm or more
|
12 participants
|
12 participants
|
|
Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors
MIO improvement < 5 mm or less
|
7 participants
|
7 participants
|
|
Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors
unknown MIO improvement
|
8 participants
|
7 participants
|
Adverse Events
Dynasplint
Serious events: 11 serious events
Other events: 9 other events
Deaths: 0 deaths
Control
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dynasplint
n=27 participants at risk
Participants randomized to this arm will be treated with the Dynasplint Trismus System
|
Control
n=26 participants at risk
Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
|
|---|---|---|
|
Gastrointestinal disorders
oral fistula
|
3.7%
1/27 • 1 year
|
0.00%
0/26 • 1 year
|
|
Gastrointestinal disorders
esophageal stenosis
|
3.7%
1/27 • 1 year
|
3.8%
1/26 • 1 year
|
|
Gastrointestinal disorders
upper GI bleed
|
3.7%
1/27 • 1 year
|
0.00%
0/26 • 1 year
|
|
Infections and infestations
facial cellulitis
|
3.7%
1/27 • 1 year
|
0.00%
0/26 • 1 year
|
|
Injury, poisoning and procedural complications
injury to carotid artery
|
3.7%
1/27 • 1 year
|
0.00%
0/26 • 1 year
|
|
Metabolism and nutrition disorders
dehydration
|
3.7%
1/27 • 1 year
|
3.8%
1/26 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
3.7%
1/27 • 1 year
|
3.8%
1/26 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
pharyngeal fistula
|
3.7%
1/27 • 1 year
|
0.00%
0/26 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
3.7%
1/27 • 1 year
|
0.00%
0/26 • 1 year
|
|
Surgical and medical procedures
debulking of scar tissue
|
3.7%
1/27 • 1 year
|
0.00%
0/26 • 1 year
|
|
Surgical and medical procedures
mandibular debridement
|
3.7%
1/27 • 1 year
|
0.00%
0/26 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
disease recurrence resulting in death
|
7.4%
2/27 • 1 year
|
3.8%
1/26 • 1 year
|
|
Surgical and medical procedures
planned procedures prior to radiation tx
|
0.00%
0/27 • 1 year
|
3.8%
1/26 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
0.00%
0/27 • 1 year
|
3.8%
1/26 • 1 year
|
|
Nervous system disorders
syncope
|
0.00%
0/27 • 1 year
|
3.8%
1/26 • 1 year
|
Other adverse events
| Measure |
Dynasplint
n=27 participants at risk
Participants randomized to this arm will be treated with the Dynasplint Trismus System
|
Control
n=26 participants at risk
Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
|
|---|---|---|
|
Gastrointestinal disorders
oral pain
|
33.3%
9/27 • 1 year
|
34.6%
9/26 • 1 year
|
Additional Information
William Carroll, MD
University of Alabama at Birmingham
Phone: 205-934-9713
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place