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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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Solvay Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title Dronabinol Placebo Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
  58.1%
19
  61.3%
37
  59.7%
>=65 years
13
  41.9%
12
  38.7%
25
  40.3%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants 31 participants 62 participants
59
(37 to 75)
57
(29 to 76)
58
(29 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
Female
31
 100.0%
30
  96.8%
61
  98.4%
Male
0
   0.0%
1
   3.2%
1
   1.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
Hispanic or Latino
1
   3.2%
1
   3.2%
2
   3.2%
Not Hispanic or Latino
30
  96.8%
30
  96.8%
60
  96.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  19.4%
8
  25.8%
14
  22.6%
White
25
  80.6%
22
  71.0%
47
  75.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   3.2%
1
   1.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
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
Number Analyzed 31 participants 31 participants 62 participants
30
  96.8%
29
  93.5%
59
  95.2%
[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.
1.Primary Outcome
Title Number of Participants With Total Protection in the Acute, Delayed and Overall Periods
Hide Description Total protection is defined as no vomiting, no rescue therapy, and no nausea as indicated by responses to the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. Data to be recorded in the study diary during the 5-day study period. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Time Frame 5 Days (first 5 days of the first cycle of chemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description:
Dronabinol 1 capsule three times per day for 5 days
Placebo 1 capsule three times per day for 5 days
Overall Number of Participants Analyzed 31 31
Measure Type: Count of Participants
Unit of Measure: Participants
Acute
22
  71.0%
14
  45.2%
Delayed
11
  35.5%
5
  16.1%
Overall
11
  35.5%
5
  16.1%
2.Secondary Outcome
Title Number of Participants With Complete Protection for the Acute, Delayed, and Overall Periods
Hide Description Complete Protection is no vomiting, no rescue therapy, and no nausea evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Time Frame Up to 5 days (first 5 days following first cycle of chemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description:
Dronabinol 1 capsule three times per day for 5 days
Placebo 1 capsule three times per day for 5 days
Overall Number of Participants Analyzed 30 29
Measure Type: Count of Participants
Unit of Measure: Participants
Acute
22
  73.3%
18
  62.1%
Delayed
14
  46.7%
10
  34.5%
Overall
14
  46.7%
9
  31.0%
3.Secondary Outcome
Title Number of Participants With Complete Response for the Acute, Delayed, and Overall Periods
Hide Description Complete response is defined as vomiting episodes with rescue medication evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Time Frame Up to 5 days (first 5 days following first cycle of chemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description:
Dronabinol 1 capsule three times per day for 5 days
Placebo 1 capsule three times per day for 5 days
Overall Number of Participants Analyzed 30 29
Measure Type: Count of Participants
Unit of Measure: Participants
Acute
22
  73.3%
19
  65.5%
Delayed
14
  46.7%
13
  44.8%
Overall
15
  50.0%
12
  41.4%
4.Secondary Outcome
Title Number of Participants With Vomiting for the Acute, Delayed and Overall Periods
Hide Description Number of Participants with Vomiting Acute, Delayed and Overall. Evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Time Frame 5 Days (first 5 days of the first cycle of chemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description:
Dronabinol 1 capsule three times per day for 5 days
Placebo 1 capsule three times per day for 5 days
Overall Number of Participants Analyzed 30 19
Measure Type: Count of Participants
Unit of Measure: Participants
Acute
6
  20.0%
3
  15.8%
Delayed
10
  33.3%
9
  47.4%
Overall
19
  63.3%
19
 100.0%
5.Secondary Outcome
Title Number of Participants With Nausea for the Acute, Delayed and Overall Periods
Hide Description Number of Participants with Nausea for the Acute, Delayed and Overall Periods. Evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Time Frame 5 Days (first 5 days of the first cycle of chemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description:
Dronabinol 1 capsule three times per day for 5 days
Placebo 1 capsule three times per day for 5 days
Overall Number of Participants Analyzed 30 29
Measure Type: Count of Participants
Unit of Measure: Participants
Acute
8
  26.7%
15
  51.7%
Delayed
19
  63.3%
23
  79.3%
Overall
11
  36.7%
5
  17.2%
6.Secondary Outcome
Title Number of Participants With Nausea and Vomiting for the Acute, Delayed and Overall Periods
Hide Description Number of Participants With Nausea and Vomiting for the Acute, Delayed and Overall Periods. Evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Time Frame 5 Days (first 5 days of the first cycle of chemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description:
Dronabinol 1 capsule three times per day for 5 days
Placebo 1 capsule three times per day for 5 days
Overall Number of Participants Analyzed 30 29
Measure Type: Count of Participants
Unit of Measure: Participants
Acute
4
  13.3%
2
   6.9%
Delayed
7
  23.3%
8
  27.6%
Overall
15
  50.0%
10
  34.5%
7.Secondary Outcome
Title Number of Participants Received Rescue Medication in the Acute, Delayed and Overall Periods
Hide Description The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present. The first section asks the patient to record presence and severity of nausea during the last 24 hours. The second section asks the patient to record vomiting episodes during the last 24 hours. The third section asks if the patient took medication for nausea or vomiting during the last 24 hours and asks how useful the treatment for nausea or vomiting was. The fourth section screens for toxicity by asking about side effects and problems experienced during the last 24 hours. Use of rescue antiemetic medication and adverse events also assessed and documented.
Time Frame 5 Days (first 5 days of the first cycle of chemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description:
Dronabinol 1 capsule three times per day for 5 days
Placebo 1 capsule three times per day for 5 days
Overall Number of Participants Analyzed 30 29
Measure Type: Count of Participants
Unit of Measure: Participants
Acute
3
  10.0%
5
  17.2%
Delayed
11
  36.7%
15
  51.7%
Response
10
  33.3%
12
  41.4%
Time Frame 2 years, 8 months
Adverse Event Reporting Description An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
 
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description Dronabinol 1 capsule three times per day for 5 days Placebo 1 capsule three times per day for 5 days
All-Cause Mortality
Dronabinol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/29 (0.00%) 
Hide Serious Adverse Events
Dronabinol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/30 (3.33%)   1/29 (3.45%) 
Blood and lymphatic system disorders     
Neutropenia † 1  1/30 (3.33%)  0/29 (0.00%) 
Gastrointestinal disorders     
Dehydration † 2  1/30 (3.33%)  0/29 (0.00%) 
Diarrhea † 2  1/30 (3.33%)  0/29 (0.00%) 
Nausea † 2  0/30 (0.00%)  1/29 (3.45%) 
Vomiting † 2  0/30 (0.00%)  1/29 (3.45%) 
Colitis † 2  0/30 (0.00%)  1/29 (3.45%) 
Metabolism and nutrition disorders     
Hyponatremia † 2  1/30 (3.33%)  0/29 (0.00%) 
1
Term from vocabulary, CTCAE (2.0)
2
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Dronabinol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   26/30 (86.67%)   25/29 (86.21%) 
Blood and lymphatic system disorders     
Anemia † 1  3/30 (10.00%)  1/29 (3.45%) 
Febrile Neutropenia † 1  1/30 (3.33%)  0/29 (0.00%) 
Leukocytosis † 1  2/30 (6.67%)  0/29 (0.00%) 
Other † 1  7/30 (23.33%)  11/29 (37.93%) 
Cardiac disorders     
Chest Pain † 1  1/30 (3.33%)  1/29 (3.45%) 
Palpitations † 1  0/30 (0.00%)  1/29 (3.45%) 
Eye disorders     
Blurred Vision † 1  1/30 (3.33%)  0/29 (0.00%) 
Conjuctivitis † 1  0/30 (0.00%)  1/29 (3.45%) 
Watering † 1  1/30 (3.33%)  1/29 (3.45%) 
Gastrointestinal disorders     
Colitis † 1  0/30 (0.00%)  1/29 (3.45%) 
Constipation † 1  14/30 (46.67%)  11/29 (37.93%) 
Diarrhea † 1  13/30 (43.33%)  6/29 (20.69%) 
Dry Mouth † 1  1/30 (3.33%)  0/29 (0.00%) 
Dyspepsia † 1  2/30 (6.67%)  2/29 (6.90%) 
Esophagitis † 1  0/30 (0.00%)  1/29 (3.45%) 
Flatulence † 1  1/30 (3.33%)  0/29 (0.00%) 
Mucositis - Oral † 1  2/30 (6.67%)  0/29 (0.00%) 
Nausea † 1  26/30 (86.67%)  25/29 (86.21%) 
Oral Pain † 1  0/30 (0.00%)  1/29 (3.45%) 
Vomiting † 1  11/30 (36.67%)  11/29 (37.93%) 
Other † 1  16/30 (53.33%)  12/29 (41.38%) 
General disorders     
Chills † 1  1/30 (3.33%)  3/29 (10.34%) 
Edema - Limbs † 1  0/30 (0.00%)  1/29 (3.45%) 
Fatigue † 1  17/30 (56.67%)  11/29 (37.93%) 
Fever † 1  1/30 (3.33%)  1/29 (3.45%) 
Flu-Like Symptoms † 1  1/30 (3.33%)  0/29 (0.00%) 
Malaise † 1  1/30 (3.33%)  0/29 (0.00%) 
Non-Cardiac Chest Pain † 1  1/30 (3.33%)  0/29 (0.00%) 
Pain † 1  4/30 (13.33%)  2/29 (6.90%) 
Other † 1  4/30 (13.33%)  1/29 (3.45%) 
Reproductive & Breast † 1  1/30 (3.33%)  0/29 (0.00%) 
Immune system disorders     
Allergeric Reaction † 1  1/30 (3.33%)  0/29 (0.00%) 
Infections and infestations     
Sinusitis † 1  0/30 (0.00%)  2/29 (6.90%) 
Other † 1  0/30 (0.00%)  1/29 (3.45%) 
Injury, poisoning and procedural complications     
Other † 1  2/30 (6.67%)  0/29 (0.00%) 
Investigations     
Alanine Aminotransferase Increase † 1  1/30 (3.33%)  1/29 (3.45%) 
Alkaline Phosphatase Increase † 1  2/30 (6.67%)  0/29 (0.00%) 
Asparate Aminotransferase Increase † 1  1/30 (3.33%)  1/29 (3.45%) 
INR Increase † 1  2/30 (6.67%)  0/29 (0.00%) 
Neutrophil Count Decrease † 1  3/30 (10.00%)  0/29 (0.00%) 
Platelet Count Decrease † 1  4/30 (13.33%)  1/29 (3.45%) 
WBC Decrease † 2  5/30 (16.67%)  2/29 (6.90%) 
Other † 1  0/30 (0.00%)  6/29 (20.69%) 
Metabolism and nutrition disorders     
Anorexia † 1  7/30 (23.33%)  8/29 (27.59%) 
Dehydration † 1  2/30 (6.67%)  0/29 (0.00%) 
Glucose intolerance † 1  0/30 (0.00%)  1/29 (3.45%) 
Hypercalcemia † 1  0/30 (0.00%)  1/29 (3.45%) 
Hyperglycemia † 1  2/30 (6.67%)  2/29 (6.90%) 
Hypoglycemia † 1  0/30 (0.00%)  1/29 (3.45%) 
Hypokalemia † 1  1/30 (3.33%)  0/29 (0.00%) 
Hyponatremia † 1  1/30 (3.33%)  1/29 (3.45%) 
Other † 1  3/30 (10.00%)  4/29 (13.79%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  1/30 (3.33%)  1/29 (3.45%) 
Arthritis † 1  0/30 (0.00%)  1/29 (3.45%) 
Back Pain † 1  7/30 (23.33%)  2/29 (6.90%) 
Bone Pain † 1  1/30 (3.33%)  3/29 (10.34%) 
General Muscle Weakness † 1  2/30 (6.67%)  0/29 (0.00%) 
Myalgia † 1  1/30 (3.33%)  0/29 (0.00%) 
Pain in Extremity † 1  2/30 (6.67%)  1/29 (3.45%) 
Other † 1  4/30 (13.33%)  3/29 (10.34%) 
Nervous system disorders     
Concentration Impairment † 1  0/30 (0.00%)  1/29 (3.45%) 
Dizziness † 1  14/30 (46.67%)  7/29 (24.14%) 
Dysgeusia † 1  0/30 (0.00%)  1/29 (3.45%) 
Headache † 1  16/30 (53.33%)  16/29 (55.17%) 
Hypersomnia † 1  0/30 (0.00%)  2/29 (6.90%) 
Lethargy † 1  1/30 (3.33%)  1/29 (3.45%) 
Paresthesia † 1  2/30 (6.67%)  0/29 (0.00%) 
Somnolence † 1  5/30 (16.67%)  3/29 (10.34%) 
Other † 1  1/30 (3.33%)  4/29 (13.79%) 
Psychiatric disorders     
Agitation † 1  0/30 (0.00%)  1/29 (3.45%) 
Anxiety † 1  1/30 (3.33%)  2/29 (6.90%) 
Euphoria † 1  3/30 (10.00%)  4/29 (13.79%) 
Insomnia † 1  15/30 (50.00%)  4/29 (13.79%) 
Other † 1  2/30 (6.67%)  2/29 (6.90%) 
Renal and urinary disorders     
Urinary Retention † 1  2/30 (6.67%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic Rhinitis † 1  2/30 (6.67%)  1/29 (3.45%) 
Dry Skin † 1  0/30 (0.00%)  1/29 (3.45%) 
Dyspnea † 1  1/30 (3.33%)  1/29 (3.45%) 
Nasal Congestion † 1  0/30 (0.00%)  1/29 (3.45%) 
Sinus † 1  1/30 (3.33%)  0/29 (0.00%) 
Sore Throat † 2  0/30 (0.00%)  1/29 (3.45%) 
Other † 1  1/30 (3.33%)  1/29 (3.45%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1  4/30 (13.33%)  3/29 (10.34%) 
Nail Loss † 1  1/30 (3.33%)  0/29 (0.00%) 
Pruritis † 1  1/30 (3.33%)  0/29 (0.00%) 
Scalp Pain † 1  0/30 (0.00%)  1/29 (3.45%) 
Skin Ulceration † 1  1/30 (3.33%)  0/29 (0.00%) 
Other † 1  5/30 (16.67%)  1/29 (3.45%) 
Vascular disorders     
Hot Flashes † 1  1/30 (3.33%)  0/29 (0.00%) 
Other † 1  1/30 (3.33%)  0/29 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
2
Term from vocabulary, CTCAE (2.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
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
Layout table for additonal information
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