Trial Outcomes & Findings for Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy (NCT NCT02539342)
NCT ID: NCT02539342
Last Updated: 2020-03-09
Results Overview
The development of Mucositis Grade \>/= 2 in children receiving chemotherapy as evaluated using CTCAE 4.0
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1 participants
Primary outcome timeframe
24 months
Results posted on
2020-03-09
Participant Flow
Participant milestones
| Measure |
Caphosol Arm
Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is \>500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a diary to record symptoms of oral mucositis.
Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:
* Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.
o Participants may increase the use to 6 times per day if you have symptoms of mucositis.
* Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.
* For younger patients (less than or equal to 6 years of age), volume may be reduced to two syringes containing 5-10 mL each.
* For patients unable to successfu
|
Control Arm
Control Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC \>500 after nadir or oral mucositis resolves (whichever occurs later)
Biotene: • Use 5 to 10 mL of Biotene to swish and spit
o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy
Baseline characteristics by cohort
| Measure |
Caphosol Arm
n=1 Participants
Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is \>500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a diary to record symptoms of oral mucositis.
Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:
* Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.
o Participants may increase the use to 6 times per day if you have symptoms of mucositis.
* Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.
* For younger patients (less than or equal to 6 years of age), volume may be reduced to two syringes containing 5-10 mL each.
* For patients unable to successfu
|
Control Arm
Control Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC \>500 after nadir or oral mucositis resolves (whichever occurs later)
Biotene: • Use 5 to 10 mL of Biotene to swish and spit
o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: We only had 1 patient enrolled on the Caphosol Arm and none on the Control Arm
The development of Mucositis Grade \>/= 2 in children receiving chemotherapy as evaluated using CTCAE 4.0
Outcome measures
| Measure |
Caphosol Arm
n=1 Participants
Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is \>500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a study diary to record symptoms of oral mucositis.
Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:
* Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.
* Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.
* Patients may use Biotene (5-10 mL) to swish and spit after the 15 minutes has passed
|
Control Arm
Control Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC \>500 after nadir or oral mucositis resolves (whichever occurs later)
Biotene: • Use 5 to 10 mL of Biotene to swish and spit
o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab.
|
|---|---|---|
|
Measure the Development of Oral Mucositis (Grade >/= 2) in Children, Adolescents and Young Adults.
Mucositis Grade >/= 2
|
1 Participants
|
0 Participants
|
|
Measure the Development of Oral Mucositis (Grade >/= 2) in Children, Adolescents and Young Adults.
Mucositis Grade </=2
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsPopulation: 1 patient enrolled on Caphosol and None on Control Arm
Any adverse events attributable to caphosol therapy being given 4 times daily
Outcome measures
| Measure |
Caphosol Arm
n=1 Participants
Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is \>500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a study diary to record symptoms of oral mucositis.
Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:
* Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.
* Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.
* Patients may use Biotene (5-10 mL) to swish and spit after the 15 minutes has passed
|
Control Arm
Control Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC \>500 after nadir or oral mucositis resolves (whichever occurs later)
Biotene: • Use 5 to 10 mL of Biotene to swish and spit
o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab.
|
|---|---|---|
|
Tolerability of Four Times Daily Caphosol Therapy
|
0 events
|
—
|
Adverse Events
Caphosol Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place