Trial Outcomes & Findings for Nexium Study To Suppress Nausea During Chemotherapy (NCT NCT00206440)

NCT ID: NCT00206440

Last Updated: 2018-12-06

Results Overview

Proportion of patients who exhibit no more than one emetic episode and who do not require rescue medication for nausea from 2-7 days following chemotherapy. Thus, we will look at esomeprazole when used to decrease the incidence,severity and duration of nausea/vomiting/retching in breast cancer patients who are receiving anthracycline-based chemotherapy.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

43 participants

Primary outcome timeframe

2-7 days following chemotheraphy

Results posted on

2018-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Esomeprazole Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.	Sugar Pill Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
Overall Study STARTED	21	22
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Esomeprazole Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.	Sugar Pill Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
Overall Study Protocol Violation	1	2
Overall Study Adverse Event	4	2

Baseline Characteristics

Nexium Study To Suppress Nausea During Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esomeprazole n=21 Participants Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.	Sugar Pill n=22 Participants Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.	Total n=43 Participants Total of all reporting groups
Age, Customized <40 years	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Age, Customized Between 40 and 49 years	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Age, Customized Between 50 and 59 years	11 participants n=5 Participants	8 participants n=7 Participants	19 participants n=5 Participants
Age, Customized Between 60 and 69 years	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Age, Customized >=70 years	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-7 days following chemotheraphy

Outcome measures

Outcome measures
Measure	Esomeprazole n=20 Participants The first dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.	Sugar Pill n=20 Participants The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
Number of Times a Subject Felt Sick to Her Stomach and Number of Times a Subject Required Rescue Medication cycle 1	0.8 Proportion of patients who exhibit no mo	0.8 Proportion of patients who exhibit no mo
Number of Times a Subject Felt Sick to Her Stomach and Number of Times a Subject Required Rescue Medication cycle 2	0.94 Proportion of patients who exhibit no mo	1 Proportion of patients who exhibit no mo

Adverse Events

Esomeprazole

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Mothaffar Rimawi

Baylor College of Medicine

Phone: 713 798 1999

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Esomeprazole n=21 participants at risk The frist dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.	Sugar Pill n=22 participants at risk The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
Gastrointestinal disorders belching	14.3% 3/21 • Number of events 3 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	0.00% 0/22 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
Musculoskeletal and connective tissue disorders bone pain	9.5% 2/21 • Number of events 2 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	0.00% 0/22 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
Gastrointestinal disorders decreased appetite	4.8% 1/21 • Number of events 2 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	0.00% 0/22 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
General disorders fatigue	19.0% 4/21 • Number of events 4 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	13.6% 3/22 • Number of events 3 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
Gastrointestinal disorders gas	9.5% 2/21 • Number of events 2 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	0.00% 0/22 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
General disorders headache	33.3% 7/21 • Number of events 11 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	36.4% 8/22 • Number of events 10 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
Gastrointestinal disorders mild nausea	19.0% 4/21 • Number of events 4 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	13.6% 3/22 • Number of events 4 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
Gastrointestinal disorders nausea	19.0% 4/21 • Number of events 6 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	31.8% 7/22 • Number of events 10 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
Gastrointestinal disorders severe nausea	19.0% 4/21 • Number of events 4 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	9.1% 2/22 • Number of events 2 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
Gastrointestinal disorders taste changes	4.8% 1/21 • Number of events 2 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	0.00% 0/22 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
General disorders tiredness	4.8% 1/21 • Number of events 2 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	0.00% 0/22 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
Gastrointestinal disorders vomiting	14.3% 3/21 • Number of events 3 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	9.1% 2/22 • Number of events 3 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
Gastrointestinal disorders constipation	4.8% 1/21 • Number of events 1 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	13.6% 3/22 • Number of events 3 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
Gastrointestinal disorders diarrhea	4.8% 1/21 • Number of events 1 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	18.2% 4/22 • Number of events 4 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
Gastrointestinal disorders heartburn	0.00% 0/21 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	9.1% 2/22 • Number of events 2 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
General disorders mild fatigue	0.00% 0/21 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	9.1% 2/22 • Number of events 2 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.
General disorders mild headache	4.8% 1/21 • Number of events 1 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.	9.1% 2/22 • Number of events 2 • Adverse events were collected after the subjects was enrolled to the study, during the study treatment, and followed up 30 days after termination from the study.