Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer
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ClinicalTrials.gov Identifier: NCT00553059 |
Recruitment Status :
Completed
First Posted : November 4, 2007
Results First Posted : October 9, 2020
Last Update Posted : October 9, 2020
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Sponsor:
M.D. Anderson Cancer Center
Collaborators:
National Cancer Institute (NCI)
Solvay Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Supportive Care |
Conditions |
Chemotherapy-induced Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific |
Interventions |
Drug: dexamethasone Drug: dronabinol Drug: palonosetron hydrochloride Other: placebo |
Enrollment | 62 |
Participant Flow
Recruitment Details | Recruitment Period: May 13, 2008 to October 26, 2011. Recruitment done in various medical clinics. |
Pre-assignment Details |
Arm/Group Title | Dronabinol | Placebo |
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Dronabinol 1 capsule three times per day for 5 days | Placebo 1 capsule three times per day for 5 days |
Period Title: Overall Study | ||
Started | 31 | 31 |
Completed | 30 | 29 |
Not Completed | 1 | 2 |
Reason Not Completed | ||
Deemed ineligible | 1 | 1 |
Drug supply not available | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Dronabinol | Placebo | Total | |
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Dronabinol 1 capsule three times per day for 5 days | Placebo 1 capsule three times per day for 5 days | Total of all reporting groups | |
Overall Number of Baseline Participants | 31 | 31 | 62 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 31 participants | 31 participants | 62 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
18 58.1%
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19 61.3%
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37 59.7%
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>=65 years |
13 41.9%
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12 38.7%
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25 40.3%
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 31 participants | 31 participants | 62 participants | |
59
(37 to 75)
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57
(29 to 76)
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58
(29 to 76)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 31 participants | 31 participants | 62 participants | |
Female |
31 100.0%
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30 96.8%
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61 98.4%
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Male |
0 0.0%
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1 3.2%
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1 1.6%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 31 participants | 31 participants | 62 participants | |
Hispanic or Latino |
1 3.2%
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1 3.2%
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2 3.2%
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Not Hispanic or Latino |
30 96.8%
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30 96.8%
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60 96.8%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 31 participants | 31 participants | 62 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
6 19.4%
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8 25.8%
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14 22.6%
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White |
25 80.6%
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22 71.0%
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47 75.8%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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1 3.2%
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1 1.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 31 participants | 31 participants | 62 participants |
31 | 31 | 62 | ||
Daily Assessment of Nausea and Vomiting
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 31 participants | 31 participants | 62 participants | |
30 96.8%
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29 93.5%
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59 95.2%
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[1]
Measure Description: To determine whether dronabinol can add significantly to the antiemetic protection provided by a standard palonosetron and dexamethasone regimen for patients receiving moderately emetogenic chemotherapy.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Michael J. Fisch, MD/Department of General Oncology |
Organization: | University of Texas (UT) MD Anderson Cancer Center |
Phone: | 713-563-9905 |
EMail: | mfisch@mdanderson.org |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00553059 |
Other Study ID Numbers: |
2006-0841 MDA-2006-0841 CDR0000573510 ( Other Identifier: NCI ) NCI-2009-00637 ( Registry Identifier: NCI CTRP ) |
First Submitted: | November 2, 2007 |
First Posted: | November 4, 2007 |
Results First Submitted: | September 15, 2020 |
Results First Posted: | October 9, 2020 |
Last Update Posted: | October 9, 2020 |