Trial Outcomes & Findings for Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin (NCT NCT00729677)

Results Overview

Recruitment status

COMPLETED

Target enrollment

64 participants

Primary outcome timeframe

Week 1 of FOLFOX chemotherapy

Results posted on

2015-10-26

Participant Flow

The original intent had been to analyze data on 100 chemotherapy cycles in 100 subjects. Instead, in order to accelerate accrual, we analyzed data on 1 cycle in 24 subjects and 2 cycles in 40 subjects.

Participant milestones

Participant milestones
Measure	Patients With Colorectal Cancer Starting Chemotherapy patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
Overall Study STARTED	64
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Colorectal Cancer Starting Chemotherapy n=64 Participants patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 1 of FOLFOX chemotherapy

Outcome measures

Outcome measures
Measure	Females n=28 Participants females starting chemotherapy for stage 3 or 4 colorectal cancer with regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.	Males n=35 Participants males starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.	Transgender n=1 Participants transgender subject starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy	64 percentage of participants	34 percentage of participants	100 percentage of participants

PRIMARY outcome

Timeframe: Week 1

Population: this data was not collected

Scale describing impact of nausea and vomiting on quality of life on a seven-point Likert Scale with higher score indicating worse quality of life.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: week 1

Number of participants with factors associated with increased frequency of nausea in the first cycle of chemotherapy, including history of motion sickness, history of pregnancy-related morning sickness, history of prior chemotherapy, and history of nausea associated with prior chemotherapy

Outcome measures

Outcome measures
Measure	Females n=23 Participants females starting chemotherapy for stage 3 or 4 colorectal cancer with regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.	Males n=41 Participants males starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.	Transgender transgender subject starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy nausea	14 participants	17 participants	—
Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy No nausea	9 participants	24 participants	—

POST_HOC outcome

Timeframe: Week 1

Number of participants on 2-drug (5HT3 inhibitor plus steroid) versus 3 drug (2-drug regimen plus an NK-1 inhibitor) who reported nausea during the first cycle of chemotherapy. 5HT-3 inhibitors included ondansetron, dolasetron, granisetron, and palonosetron. The NK-1 inhibitor was aprepitant. The steroid was dexamethasone.

Outcome measures

Outcome measures
Measure	Females n=50 Participants females starting chemotherapy for stage 3 or 4 colorectal cancer with regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.	Males n=14 Participants males starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.	Transgender transgender subject starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy Reported nausea	24 participants	6 participants	—
Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy No nausea	26 participants	8 participants	—

Adverse Events

Patients With Colorectal Cancer Starting Chemotherapy

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

Victoria Rosenwald, RN MPH

Beth Israel Cancer Center

Phone: 212 844-8285

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place