dexamethasone
10 mg IV 30 minutes prior to administration of chemotherapy
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The goal of this clinical research study is to learn if adding dronabinol in combination with the standard of care (dexamethasone and palonosetron) can better help to control nausea and vomiting in patients receiving chemotherapy. The safety of the drug combinations will also be studied.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2020-10-09
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
The Study Drugs: Dronabinol and palonosetron are both designed to help prevent nausea and vomiting in patients who are receiving chemotherapy. Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to MM patients in combination with other chemotherapy to treat cancer. Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. * If you are in Group 1, you will take dronabinol, dexamethasone, and palonosetron. * If you are in Group 2, you will take a placebo, dexamethasone, and palonosetron. A placebo is a substance that looks like the study drug but has no active ingredients. You will have an equal chance of being assigned to either group. Neither you nor your doctor can choose the group you will be in. During the study, you and the study staff will not know which group you are in. However, if needed for your safety, the study staff will be able to find out which group you are in. After the last study participant completes their study therapy, you and the study staff will find out which group you were in. Study Drug Administration: On Day 1 (the day that you receive chemotherapy), you will take a dronabinol/placebo pill by mouth every 8 hours (if possible). If you cannot take the pill every 8 hours, you should try to space out the doses evenly. Your first dronabinol/placebo pill on Day 1 will be 30 minutes before chemotherapy. You will also receive dexamethasone and palonosetron by vein 30 minutes before you receive chemotherapy. On Days 2-6, you will take dronabinol/placebo 3 times a day. You should take each pill every 8 hours (if possible). If you cannot take them every 8 hours, you should try to space out the doses evenly. Study Diary: You will complete a study diary on Days 1-6. In this diary you will answer questions about nausea and vomiting. Study Visits: You will have a study visit on Day 8 and again sometime during Days 14-28. At both visits, you will be asked if you have experienced any side effects. You should return your study diary to the clinic at both visits. At the visit during Days 14-28, you will also have a physical exam. Length of Study: You will be on study for 30 days. You will be taken off study early if the nausea and vomiting do not improve or intolerable side effects occur. This is an investigational study. Dronabinol and palonosetron are both FDA approved and commercially available to prevent nausea and vomiting that may occur from chemotherapy. Dexamethasone is FDA approved and commercially available for the prevention of side effects related to chemotherapy. The combination of these drugs to prevent nausea and vomiting is investigational. Up to 200 patients will take part in this multicenter study. Up to 200 will be enrolled at M. D. Anderson.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
10 mg IV 30 minutes prior to administration of chemotherapy
5 mg tablet by mouth three times a day beginning 30 minutes before chemotherapy
0.25 mg IV 30 minutes prior to administration of chemotherapy
1 tablet by mouth three times a day beginning 30 minutes before chemotherapy
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Dronabinol | 31 | 22 | - |
| Placebo | 31 | 14 | - |
| Dronabinol | 31 | 11 | - |
| Placebo | 31 | 5 | - |
| Dronabinol | 31 | 11 | - |
| Placebo | 31 | 5 | - |
Eligibility
primary outcomes
Time frame: 5 Days (first 5 days of the first cycle of chemotherapy)
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.
secondary outcomes
Time frame: Up to 5 days (first 5 days following first cycle of chemotherapy)
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)
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: 5 Days (first 5 days of the first cycle of chemotherapy)
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)
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.
Publications
No exact PMID-linked public article is currently readable locally.
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Dronabinol | 30 | 22 | - |
| Placebo | 29 | 18 | - |
| Dronabinol | 30 | 14 | - |
| Placebo | 29 | 10 | - |
| Dronabinol | 30 | 14 | - |
| Placebo | 29 | 9 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Dronabinol | 30 | 22 | - |
| Placebo | 29 | 19 | - |
| Dronabinol | 30 | 14 | - |
| Placebo | 29 | 13 | - |
| Dronabinol | 30 | 15 | - |
| Placebo | 29 | 12 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Dronabinol | 30 | 6 | - |
| Placebo | 19 | 3 | - |
| Dronabinol | 30 | 10 | - |
| Placebo | 19 | 9 | - |
| Dronabinol | 30 | 19 | - |
| Placebo | 19 | 19 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Dronabinol | 30 | 8 | - |
| Placebo | 29 | 15 | - |
| Dronabinol | 30 | 19 | - |
| Placebo | 29 | 23 | - |
| Dronabinol | 30 | 11 | - |
| Placebo | 29 | 5 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Dronabinol | 30 | 4 | - |
| Placebo | 29 | 2 | - |
| Dronabinol | 30 | 7 | - |
| Placebo | 29 | 8 | - |
| Dronabinol | 30 | 15 | - |
| Placebo | 29 | 10 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Dronabinol | 30 | 3 | - |
| Placebo | 29 | 5 | - |
| Dronabinol | 30 | 11 | - |
| Placebo | 29 | 15 | - |
| Dronabinol | 30 | 10 | - |
| Placebo | 29 | 12 | - |
| Milestone | Dronabinol | Placebo |
|---|---|---|
| STARTED | 31 | 31 |
| COMPLETED | 30 | 29 |
| NOT COMPLETED | 1 | 2 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Dehydration | Gastrointestinal disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Hyponatremia | Metabolism and nutrition disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Diarrhea | Gastrointestinal disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Nausea | Gastrointestinal disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Vomiting | Gastrointestinal disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Colitis | Gastrointestinal disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | Dronabinol: 3 / 30 · Placebo: 1 / 29 |
| Febrile Neutropenia | Blood and lymphatic system disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Leukocytosis | Blood and lymphatic system disorders | Dronabinol: 2 / 30 · Placebo: 0 / 29 |
| Other | Blood and lymphatic system disorders | Dronabinol: 7 / 30 · Placebo: 11 / 29 |
| Chest Pain | Cardiac disorders | Dronabinol: 1 / 30 · Placebo: 1 / 29 |
| Palpitations | Cardiac disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Blurred Vision | Eye disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Conjuctivitis | Eye disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Watering | Eye disorders | Dronabinol: 1 / 30 · Placebo: 1 / 29 |
| Colitis | Gastrointestinal disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Constipation | Gastrointestinal disorders | Dronabinol: 14 / 30 · Placebo: 11 / 29 |
| Diarrhea | Gastrointestinal disorders | Dronabinol: 13 / 30 · Placebo: 6 / 29 |
| Dry Mouth | Gastrointestinal disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Dyspepsia | Gastrointestinal disorders | Dronabinol: 2 / 30 · Placebo: 2 / 29 |
| Esophagitis | Gastrointestinal disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Flatulence | Gastrointestinal disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Mucositis - Oral | Gastrointestinal disorders | Dronabinol: 2 / 30 · Placebo: 0 / 29 |
| Nausea | Gastrointestinal disorders | Dronabinol: 26 / 30 · Placebo: 25 / 29 |
| Oral Pain | Gastrointestinal disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Vomiting | Gastrointestinal disorders | Dronabinol: 11 / 30 · Placebo: 11 / 29 |
| Other | Gastrointestinal disorders | Dronabinol: 16 / 30 · Placebo: 12 / 29 |
| Chills | General disorders | Dronabinol: 1 / 30 · Placebo: 3 / 29 |
| Edema - Limbs | General disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Fatigue | General disorders | Dronabinol: 17 / 30 · Placebo: 11 / 29 |
| Fever | General disorders | Dronabinol: 1 / 30 · Placebo: 1 / 29 |
| Flu-Like Symptoms | General disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Malaise | General disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Non-Cardiac Chest Pain | General disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Pain | General disorders | Dronabinol: 4 / 30 · Placebo: 2 / 29 |
| Other | General disorders | Dronabinol: 4 / 30 · Placebo: 1 / 29 |
| Allergeric Reaction | Immune system disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Sinusitis | Infections and infestations | Dronabinol: 0 / 30 · Placebo: 2 / 29 |
| Other | Infections and infestations | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Other | Injury, poisoning and procedural complications | Dronabinol: 2 / 30 · Placebo: 0 / 29 |
| Alanine Aminotransferase Increase | Investigations | Dronabinol: 1 / 30 · Placebo: 1 / 29 |
| Alkaline Phosphatase Increase | Investigations | Dronabinol: 2 / 30 · Placebo: 0 / 29 |
| Asparate Aminotransferase Increase | Investigations | Dronabinol: 1 / 30 · Placebo: 1 / 29 |
| INR Increase | Investigations | Dronabinol: 2 / 30 · Placebo: 0 / 29 |
| Neutrophil Count Decrease | Investigations | Dronabinol: 3 / 30 · Placebo: 0 / 29 |
| Platelet Count Decrease | Investigations | Dronabinol: 4 / 30 · Placebo: 1 / 29 |
| WBC Decrease | Investigations | Dronabinol: 5 / 30 · Placebo: 2 / 29 |
| Other | Investigations | Dronabinol: 0 / 30 · Placebo: 6 / 29 |
| Anorexia | Metabolism and nutrition disorders | Dronabinol: 7 / 30 · Placebo: 8 / 29 |
| Dehydration | Metabolism and nutrition disorders | Dronabinol: 2 / 30 · Placebo: 0 / 29 |
| Glucose intolerance | Metabolism and nutrition disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Hypercalcemia | Metabolism and nutrition disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Hyperglycemia | Metabolism and nutrition disorders | Dronabinol: 2 / 30 · Placebo: 2 / 29 |
| Hypoglycemia | Metabolism and nutrition disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Hypokalemia | Metabolism and nutrition disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Hyponatremia | Metabolism and nutrition disorders | Dronabinol: 1 / 30 · Placebo: 1 / 29 |
| Other | Metabolism and nutrition disorders | Dronabinol: 3 / 30 · Placebo: 4 / 29 |
| Arthralgia | Musculoskeletal and connective tissue disorders | Dronabinol: 1 / 30 · Placebo: 1 / 29 |
| Arthritis | Musculoskeletal and connective tissue disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Back Pain | Musculoskeletal and connective tissue disorders | Dronabinol: 7 / 30 · Placebo: 2 / 29 |
| Bone Pain | Musculoskeletal and connective tissue disorders | Dronabinol: 1 / 30 · Placebo: 3 / 29 |
| General Muscle Weakness | Musculoskeletal and connective tissue disorders | Dronabinol: 2 / 30 · Placebo: 0 / 29 |
| Myalgia | Musculoskeletal and connective tissue disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Dronabinol: 2 / 30 · Placebo: 1 / 29 |
| Other | Musculoskeletal and connective tissue disorders | Dronabinol: 4 / 30 · Placebo: 3 / 29 |
| Concentration Impairment | Nervous system disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Dizziness | Nervous system disorders | Dronabinol: 14 / 30 · Placebo: 7 / 29 |
| Dysgeusia | Nervous system disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Headache | Nervous system disorders | Dronabinol: 16 / 30 · Placebo: 16 / 29 |
| Hypersomnia | Nervous system disorders | Dronabinol: 0 / 30 · Placebo: 2 / 29 |
| Lethargy | Nervous system disorders | Dronabinol: 1 / 30 · Placebo: 1 / 29 |
| Paresthesia | Nervous system disorders | Dronabinol: 2 / 30 · Placebo: 0 / 29 |
| Somnolence | Nervous system disorders | Dronabinol: 5 / 30 · Placebo: 3 / 29 |
| Other | Nervous system disorders | Dronabinol: 1 / 30 · Placebo: 4 / 29 |
| Agitation | Psychiatric disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Anxiety | Psychiatric disorders | Dronabinol: 1 / 30 · Placebo: 2 / 29 |
| Euphoria | Psychiatric disorders | Dronabinol: 3 / 30 · Placebo: 4 / 29 |
| Insomnia | Psychiatric disorders | Dronabinol: 15 / 30 · Placebo: 4 / 29 |
| Other | Psychiatric disorders | Dronabinol: 2 / 30 · Placebo: 2 / 29 |
| Urinary Retention | Renal and urinary disorders | Dronabinol: 2 / 30 · Placebo: 0 / 29 |
| Reproductive & Breast | General disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Dronabinol: 2 / 30 · Placebo: 1 / 29 |
| Dry Skin | Respiratory, thoracic and mediastinal disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Dronabinol: 1 / 30 · Placebo: 1 / 29 |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Sinus | Respiratory, thoracic and mediastinal disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Other | Respiratory, thoracic and mediastinal disorders | Dronabinol: 1 / 30 · Placebo: 1 / 29 |
| Alopecia | Skin and subcutaneous tissue disorders | Dronabinol: 4 / 30 · Placebo: 3 / 29 |
| Nail Loss | Skin and subcutaneous tissue disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Pruritis | Skin and subcutaneous tissue disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Scalp Pain | Skin and subcutaneous tissue disorders | Dronabinol: 0 / 30 · Placebo: 1 / 29 |
| Skin Ulceration | Skin and subcutaneous tissue disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Other | Skin and subcutaneous tissue disorders | Dronabinol: 5 / 30 · Placebo: 1 / 29 |
| Hot Flashes | Vascular disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
| Other | Vascular disorders | Dronabinol: 1 / 30 · Placebo: 0 / 29 |
Time frame: 5 Days (first 5 days of the first cycle of chemotherapy)
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)
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.