Trial Outcomes & Findings for Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study (NCT NCT01183481)
NCT ID: NCT01183481
Last Updated: 2019-10-09
Results Overview
Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.
TERMINATED
PHASE2
19 participants
Days 2-10 following radiotherapy
2019-10-09
Participant Flow
Patients were enrolled between January 2011 and October 2012 in a radiation oncology clinic
No enrolled patients were later excluded.
Participant milestones
| Measure |
Aprepitant and Granisetron
Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
|
|---|---|
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Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study
Baseline characteristics by cohort
| Measure |
Aprepitant and Granisetron
n=19 Participants
Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 15.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 2-10 following radiotherapyAssessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.
Outcome measures
| Measure |
Aprepitant and Granisetron
n=19 Participants
Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
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|---|---|
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The Proportion of Patients Experiencing no Vomiting and no Nausea, Without Use of Any Rescue Antiemetic Medication(s), From Days 2-10 Following the Radiation Therapy (Delayed RINV).
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19 participants
|
SECONDARY outcome
Timeframe: From day of radiotherapy to 10 days following radiotherapyData will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of radiotherapy and 24 hours followingPopulation: Patients undergoing single fraction treatment
Percentage of participants experiencing no nausea, vomiting, and retching during the acute phase was assessed. Assessments of nausea, vomiting, and antiemetic use will be taken daily following the radiation therapy based on patient self-report nausea/vomiting diaries.
Outcome measures
| Measure |
Aprepitant and Granisetron
n=13 Participants
Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
|
|---|---|
|
Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy
Control rate of acute phase nausea
|
100 percentage of participants
|
|
Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy
Control rate of acute phase vomiting/retching
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Days 2-10 following radiotherapyPopulation: Patients undergoing single fraction treatment
Percentage of participants in the single fraction arm experiencing no nausea, vomiting, and retching was assessed. Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.
Outcome measures
| Measure |
Aprepitant and Granisetron
n=13 Participants
Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
|
|---|---|
|
Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy
Control rate of delayed phase nausea
|
62 percentage of participants
|
|
Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy
Control rate of delayed phase vomiting/retching
|
85 percentage of participants
|
SECONDARY outcome
Timeframe: During radiotherapy (5 days) and the 24 hours following radiotherapyPopulation: Patients undergoing multiple fraction treatment
Percentage of participants in the multiple fraction arm experiencing no nausea, vomiting, and retching was assessed. Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame.
Outcome measures
| Measure |
Aprepitant and Granisetron
n=6 Participants
Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
|
|---|---|
|
Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy
Control rate of acute phase vomiting/retching
|
67 percentage of participants
|
|
Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy
Control rate of acute phase nausea
|
67 percentage of participants
|
SECONDARY outcome
Timeframe: Days 2-10 following radiotherapyPopulation: Patients undergoing multiple fraction treatment
Percentage of participants experiencing no nausea, vomiting, and retching was assessed. Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.
Outcome measures
| Measure |
Aprepitant and Granisetron
n=6 Participants
Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
|
|---|---|
|
Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy
Control rate of delayed phase nausea
|
83 percentage of participants
|
|
Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy
Control rate of delayed phase vomiting/retching
|
83 percentage of participants
|
Adverse Events
Aprepitant and Granisetron
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aprepitant and Granisetron
n=19 participants at risk
Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
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|---|---|
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Musculoskeletal and connective tissue disorders
Pain crisis
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5.3%
1/19
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place