Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site
Conditions
Interventions
Intervention1: Pillcraft “Solazen ?: 1 ml dose, twice/thrice a day after meals (subject to tolerance and investigator’s discretion) for 3 months.
Intervention2: Pillcraft “Oncozen ?: 1 ml dose, twice/
Sponsors
Pillcraft Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female patients aged between 18-70 years (both inclusive); 2.The patient diagnosed with metastatic breast cancer including but not limited to bone metastases of severity stage 4 underwent surgery, and/ or, receiving chemotherapy, radiation or immunotherapy; 3.The patient has a clinical diagnosis of cancer-related pain (NPRS scale score between 1-6 i.e., mild to moderate pain); 4.The patient receiving Step I or II pain medication according to the World Health Organization (WHO) analgesic ladder. ?First step - Mild pain: non-opioid analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen with or without adjuvants ?Second step - Moderate pain: weak opioids (hydrocodone, codeine, tramadol) with or without non-opioid analgesics, and with or without adjuvants ? Third step - Severe and persistent pain: potent opioids (morphine, methadone, fentanyl, oxycodone, buprenorphine, tapentadol, hydromorphone, oxymorphone) with or without non-opioid analgesics, and with or without adjuvants 5.The patient is able (in the investigators opinion) and willing to comply with all study requirements; 6.With or without comorbidity, if comorbid on stable prescription.
Exclusion criteria
Exclusion criteria: The patients should not present any of the following exclusion criteria- 1.Patients eligible for hospice care that is when a patient has stopped responding to all possible treatments for their illness; 2.Using medical marijuana currently; 3.Have a known sensitivity to cannabinoids; 4.Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition; 5.Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non-prescribed use of any prescription drug; 6.The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure); 7.The patient has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator, would put the patient at risk of a clinically relevant arrhythmia or myocardial infarction; 8.Patients on other medications which will likely have a drug interaction with cannabis- such as clozapine, duloxetine, naproxen, cyclobenzaprine, olanzapine, haloperidol, and chlorpromazine, macrolides, calcium channel blockers, benzodiazepines, cyclosporine, sildenafil (and other PDE5 inhibitors), antihistamines, haloperidol, antiretroviral; 9.Inability to take oral medications and/or painful erythema, oedema or ulcers under the tongue. 10.Uncontrolled diarrhea, nausea, vomiting, sub ileus or intestinal obstruction. 11.Systemic diseases like uncontrolled hypertension, uncontrolled diabetes, heart diseases, and lung diseases as per investigator’s discretion; 12.Subjects with the presence or suspected to have metastatic changes in the liver at the time of screening; 13.Patients having deranged biochemical parameters from blood samples at screening: •AST (SGOT), ALT (SGPT) greater than 1.5 x ULN if no evidence of liver metastases; •Total bilirubin greater than1.5 mg/dL; •Creatinine greater than 2 mg/dL; •Alkaline phosphatase greater than 5 x ULN. 14.Patients having the deranged hematology levels at screening like: •Platelets less than 100 x 109 cells/L; •Hemoglobin less than 9 gm/dL. 15.Pregnancy and breastfeeding women; 16. Any other illness or abnormal laboratory investigations which the investigator considers as making the patient ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in cancer related pain using Numeric Pain Rating Scale (NPRS) at screening, week 1,2,3,4,6,8,10, & 12. 2. Changes in dependency on pain medications at screening, week 4, 8, & 12. 3. Changes in quality-of-life score assessed by FACT-G questionnaire at screening, week 2,4,8, and 12.Timepoint: 1.Screening Visit 2.Baseline Day(Visit 1) 3.Week 1 (Visit 2) 4.Week 2 (Visit 3) 5.Week 3 (Visit 4) 6.Week 4 (Visit 5) 7.Week 6 (Visit 6) 8.Week 8 (Visit 7) 9.Week 10 (Visit 8) 10.Week 12 (Visit 9) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in Simplified Nutritional Appetite Questionnaire (SNAQ) score at screening, week 2,4,8, & 12. 2. Changes in cancer related fatigue using Brief Fatigue Inventory (BFI) score at screening, week 2,4,8, and 12. 3. Changes in chemotherapy induced nausea and vomiting (CINV) at screening, week 2,4,8, and 12. 4. Changes in Pittsburgh Sleep Quality Index (PSQI) score at screening, week 2,4,8, and 12. 5. Changes in cancer specific biomarker based on cancer type as per the discretion of investigator at screening and week 12.Timepoint: 1.Screening Visit 2.Baseline Day(Visit 1) 3.Week 1 (Visit 2) 4.Week 2 (Visit 3) 5.Week 3 (Visit 4) 6.Week 4 (Visit 5) 7.Week 6 (Visit 6) 8.Week 8 (Visit 7) 9.Week 10 (Visit 8) 10.Week 12 (Visit 9) | — |
Countries
India
Contacts
Public ContactDhawal Chopda
Pillcraft Private Limited
Outcome results
None listed