Trial · NCT03040726

Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer

NCT03040726, Phase 2, Phase 3, Completed, M.D. Anderson Cancer Center; results first posted 2023-10-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer. Trials, record NCT03040726. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03040726

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer
NCT number: NCT03040726
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 53 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Malignant Neoplasm, Nausea, Vomiting
Interventions: Netupitant, Palonosetron, Palonosetron Hydrochloride, Placebo, Questionnaire Administration
First posted: 2017-02-02
Last updated: 2023-10-17
Results first posted: 2023-10-17

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Nausea Numerical Rating Scale (NRS) Between Day 5 and Day 15	Day 5 and Day 15	Average intensity of nausea over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10, where 0= none and 10= worse possible nausea. The total score ranged from 0-10. We measured the within-group change in nausea intensity from day 5 to day 15. Wilcoxon rank sum test was used for analysis.
Secondary	Functional Living Index Emesis (FLIE): Nausea Sub-score	Baseline and Day 15	FLIE is a questionnaire validated to assess the impact of chemotherapy induced nausea and vomiting on patient's function and quality of life over the past 5 days. It consists of 18 items, with 9 items on nausea and 9 items on vomiting. Each question was rated using a Numerical Rating Scale (NRS) from 1 to 7. The total Nausea sub-score ranges from 9 to 63, where a higher score indicates higher quality of life. We measured the change of nausea sub-score between baseline 5 to day 15. Wilcoxon rank sum test was used for analysis.
Secondary	Functional Living Index Emesis (FLIE): Vomiting Sub-score	Baseline and Day 15	FLIE is a questionnaire validated to assess the impact of chemotherapy induced nausea and vomiting on patient's function and quality of life over the past 5 days. It consists of 18 items, with 9 items on nausea and 9 items on vomiting. Each question was rated using a Numerical Rating Scale (NRS) from 1 to 7. The total Vomiting sub-score ranges from 9 to 63, where a higher score indicates higher quality of life. We measured the change of vomiting sub-score from baseline to day 15.Wilcoxon rank sum test was used for analysis.
Secondary	Index of Nausea, Vomiting and Retching: Total Experience Score	Day 5 and Day 15	Index of Nausea, Vomiting, and Retching, which consists of 8 items asking about the patient's experience regarding nausea and vomiting over the past 12 hours. Each item included a 5-point Likert scale (0-4 points) with descriptive words. Total experience score ranged from 0-32 with higher score indicates more nausea/vomiting. We measured the change in score between day 5 and day 15. Wilcoxon rank sum test was used for analysis.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Nausea Numerical Rating Scale (NRS) Between Day 5 and Day 15	Day 5 and Day 15	Those who completed Day 15	score on a scale	MEAN
SECONDARY	Functional Living Index Emesis (FLIE): Nausea Sub-score	Baseline and Day 15	Those who completed Day 15	score on a scale	MEAN
SECONDARY	Functional Living Index Emesis (FLIE): Vomiting Sub-score	Baseline and Day 15	Those who completed Day 15	score on a scale	MEAN
SECONDARY	Index of Nausea, Vomiting and Retching: Total Experience Score	Day 5 and Day 15	Those who completed Day 15	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Nausea Numerical Rating Scale (NRS) Between Day 5 and Day 15	Blinded Intervention Group	-2.0	95% Confidence Interval -3.1 to -0.8	score on a scale
Change in Nausea Numerical Rating Scale (NRS) Between Day 5 and Day 15	Blinded Placebo Group	-2.3	95% Confidence Interval -3.9 to -0.7	score on a scale
Functional Living Index Emesis (FLIE): Nausea Sub-score	Blinded Intervention Group.	-16.6	95% Confidence Interval -22.6 to -10.5	score on a scale
Functional Living Index Emesis (FLIE): Nausea Sub-score	Blinded Placebo Group	-18	95% Confidence Interval -22.0 to -14.0	score on a scale
Functional Living Index Emesis (FLIE): Vomiting Sub-score	Blinded Intervention Group	-12.5	95% Confidence Interval -20.8 to -4.2	score on a scale
Functional Living Index Emesis (FLIE): Vomiting Sub-score	Blinded Placebo Group	-9.7	95% Confidence Interval -18.2 to -1.2	score on a scale
Index of Nausea, Vomiting and Retching: Total Experience Score	Blinded Intervention Group	-2.3	95% Confidence Interval -4.4 to -0.3	score on a scale
Index of Nausea, Vomiting and Retching: Total Experience Score	Blinded Placebo Group	-2.5	95% Confidence Interval -6.9 to 1.9	score on a scale

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Blinded Intervention gp.	31
Overall Study	STARTED	Blinded Placebo gp.	15
Overall Study	Started Placebo run-in Phase	Blinded Intervention gp.	31
Overall Study	Started Placebo run-in Phase	Blinded Placebo gp.	15
Overall Study	Started Blinded Phase	Blinded Intervention gp.	22
Overall Study	Started Blinded Phase	Blinded Placebo gp.	11
Overall Study	COMPLETED	Blinded Intervention gp.	21
Overall Study	COMPLETED	Blinded Placebo gp.	9
Overall Study	NOT COMPLETED	Blinded Intervention gp.	10
Overall Study	NOT COMPLETED	Blinded Placebo gp.	6

Source ClinicalTrials.gov

Adverse events38

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cough	Respiratory, thoracic and mediastinal disorders	Blinded Intervention gp.	1	30
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo gp.	0	43
other	Abdominal Pain	Gastrointestinal disorders	Blinded Intervention gp.	1	30
other	Abdominal Pain	Gastrointestinal disorders	Placebo gp.	0	43
other	Back pain	Musculoskeletal and connective tissue disorders	Blinded Intervention gp.	1	30
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo gp.	1	43
other	Dizziness	Nervous system disorders	Blinded Intervention gp.	0	30
other	Dizziness	Nervous system disorders	Placebo gp.	1	43
other	Headache	Nervous system disorders	Blinded Intervention gp.	3	30
other	Headache	Nervous system disorders	Placebo gp.	3	43

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Blinded Intervention gp.	3	30
Total, all-cause mortality	Placebo gp.	2	43
Total, other adverse events	Blinded Intervention gp.	10	30
Total, other adverse events	Placebo gp.	9	43
Total, serious adverse events	Blinded Intervention gp.	1	30
Total, serious adverse events	Placebo gp.	3	43

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33388382	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA016672	The University of Texas MD Anderson Cancer Center Support Grant (CCSG)	KOONG, ALBERT	UNIVERSITY OF TX MD ANDERSON CAN CTR	NATIONAL CANCER INSTITUTE	1985 to 2026

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Blinded Intervention gp. vs Placebo gp.: deaths from any cause	Trial comparisons
Blinded Intervention gp. vs Placebo gp.: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03040726

GET https://conductscience.org/api/trials/v1/NCT03040726/events?page=2

API reference For AI assistants