|
Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer Clinical research trials and Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer. Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer  Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer
Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer
For Condition: stage 4 breast cancer,recurrent prostate cancer,recurrent breast cancer,stage 4 prostate cancer,Pain
Status: Suspended
Sponsor(s): University of California, San Francisco , National Cancer Institute (NCI)
Synopsis: RATIONALE: Morphine helps to relieve the pain associated with bone metastases. Marijuana may be effective in controlling pain and nausea and vomiting. Combining morphine with marijuana may provide more pain relief and may help to reduce or prevent nausea and vomiting in patients treated with opioids. PURPOSE: Clinical trial to study the effectiveness of combining morphine with marijuana in treating pain caused by bone metastases in patients who have breast or prostate cancer.
Details: OBJECTIVES: - Determine the short-term additive analgesic effects of smoked marijuana in combination with morphine for the treatment of persistent pain secondary to bone metastases in patients with breast or prostate cancer. - Determine the short-term antinausea and antiemetic effects of marijuana in patients with opioid-related nausea and vomiting. - Determine the analgesic effects of marijuana on study-induced pain by using a heat/capsaicin pain model and cutaneous secondary hyperanalgesia in these patients. - Determine the changes in mood in patients treated with this regimen. OUTLINE: This is a pilot study. Patients smoke 1 marijuana cigarette 3 times daily on days 1-7. Patients also receive oral morphine according to their pre-study schedule. Patients undergo heat and capsaicin skin sensitization to the forearm at baseline and on days 1 and 7 during study. Patients complete a daily pain diary and questionnaire for 7 days prior to, during, and for 7 days after study. Patients also complete a nausea and vomiting questionnaire once daily for 2 days prior to study and on days 1-7 during study. PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Persistent pain secondary to bone metastases - Average daily pain score of at least 30 mm (despite treatment with morphine) on the 100-mm Visual Analog Scale over a 7-day period - Diagnosis of breast or prostate cancer with evidence of bone metastases by radiography or nuclear medicine scan - Must have previously smoked marijuana on at least 6 occasions in a lifetime - Must be on a stable dose of opioid medication or other stable medication regimen for at least 2 weeks prior to study - Able to develop temporary secondary hyperanalgesia from screening heat and capsaicin stimulation - No heat pain detection threshold above 47° Celsius on the arm - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - Adult Sex - Not specified Menopausal status - Not specified Performance status - Karnofsky 50-100% Life expectancy - Not specified Hematopoietic - No evidence of hematological dysfunction Hepatic - No history of hepatic failure - No evidence of hepatic dysfunction Renal - No history of renal failure - No evidence of renal dysfunction Cardiovascular - No severe coronary artery disease - No uncontrolled hypertension - No cardiac ventricular conduction abnormality - No orthostatic mean blood pressure drop greater than 24 mm Hg Pulmonary - No severe chronic obstructive pulmonary disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Must be able to read and speak English - Able to understand and follow investigator's instructions, including completing pain intensity rating scales - No diabetes mellitus - No dermatopathology, skin hypersensitivity, or skin lesions in areas of measurements - No allergy to opioids, capsaicin, lidocaine, or marijuana - No active substance abuse (e.g., alcohol or injection drugs) - No neurologic dysfunction or psychiatric disorder that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 4 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy - No concurrent steroids (topical or systemic) Radiotherapy - More than 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - More than 30 days since prior inhaled or ingested marijuana or other cannabinoids - More than 30 days since prior dronabinol (marinol) - More than 4 weeks since prior bisphosphonates - No concurrent bisphosphonates - No concurrent smoked tobacco products - No concurrent methadone
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DonaldAbrams, Study Chair, Oncology Service of San Francisco General Hospital Medical Center
UCSF Comprehensive Cancer Center
San Francisco, California, 94110
United States
Additional Information:
Study ID Numbers: CDR0000258783; UCSF-01995,UCSF-H105-18272-01
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052871
Other Stage 4 Prostate Cancer Studies:
1. Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women with Metastatic Breast Cancer
2. Docetaxel and Trastuzumab With or Without Carboplatin in Treating Women With HER2-Positive Breast Cancer
3. Docetaxel in Treating Patients With Metastatic Breast Cancer
4. Trastuzumab and Flavopiridol in Treating Patients With Metastatic Breast Cancer
5. Tipifarnib and Fulvestrant as Second-Line Therapy in Treating Postmenopausal Women With Hormone Receptor-Positive Inoperable Locally Advanced or Metastatic Breast Cancer With Progressive Disease After Previous First-Line Endocrine Therapy
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer
|
|
|
|
|
|
|
|
