Cancer patients prescribing opioids
Conditions
Interventions
Magnesium oxide
Naldemedine
Sponsors
Yokohama city university hospotal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1,Patients aged 20 to 85 years of age at the time of acquisition. 2,Gender, hospitalization / outpatient: no question 3,Patients who are not undergoing opioid analgesic treatment 4,Patients scheduled to use opioids due to cancer pain 5,Patients who can take oral medicine, meals and drinks 6,Patient who can be evaluated by patient diary (Surrogate record to patient's diary is permitted only when patient's own evaluation is possible) 7,Patients who are expected to have stable cancer pathology during the observation period 8,Patient who got written consent from participants to participate in this research, observe observance matter participating in this research, undergo examination prescribed in this research plan, and can declare symptoms etc.
Exclusion criteria
Exclusion criteria: 1,Patients who are contraindicated in the package inserts of magnesium oxide and naldemedine and patients who have a history of hypersensitivity to the components of this drug. 2,Serious structural abnormalities of the digestive tract (eg mechanical ileus), diseases affecting intestinal transport (eg paralytic ileus, peritoneal dissemination affecting gastrointestinal function, peritoneal cancer, uncontrolled thyroid function decline (IBS), inflammatory bowel disease (eg ulcerative colitis, Crohn's disease), active diverticular disease, pelvic disorders causing constipation (uterine prolapse, rectal prolapse, defecation A patient with uterine fibroids affecting). Also, even if these diseases are cured at present, patients judged by doctors to affect digestive tract function 3,Patient who is breastfeeding or may be pregnant. 4,Patients who underwent surgery that affects gastrointestinal function, treatment (eg nerve block) or radiotherapy affecting gastrointestinal function within 28 days from the date of registration or patients scheduled to be performed during the observation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PAC-QOL overall score difference after 2 weeks of treatment start from Baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1,PAC-SYM overall score difference after 2 weeks of treatment start from Baseline. 2,CSS overall score difference after 2 weeks of treatment start from Baseline. 3,Difference in the presence or absence of constipation by Rome IV (all observation period) after 2 weeks of treatment start from Baseline. 4,Bristol scale overall score difference after 2 weeks of treatment start from Baseline. 5,SMBs overall score difference after 2 weeks of treatment start from Baseline. 6,PAC-QOL overall score difference after 12 weeks of treatment start from Baseline. 7,PAC-SYM overall score difference after 12 weeks of treatment start from Baseline. 8,CSS overall score difference after 12 weeks of treatment start from Baseline. 9,Difference in the presence or absence of constipation by Rome IV (all observation period) after 12 weeks of treatment start from Baseline. 10,Bristol scale overall score difference after 12 weeks of treatment start from Baseline. 11,SMBs overall score difference after 12 weeks of treatment start from Baseline. 12,Oral compliance rate | — |
Countries
Japan
Contacts
Public ContactTakaomi Kessoku
Yokohama city university hospotal Palliative care
Outcome results
None listed