neoplasms Cancer, Opioid induced constipation
Conditions
Interventions
Patients who meet the patient eligibility and exclusion criteria and give consent will be randomly assigned to the naldemedine group (Symproic 0.2 mg) or placebo group. The study evaluation period wil
drug therapy
Sponsors
Jun Hamano
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cancer patients who are starting regular oral use of strong opioids (morphine, oxycodone, hydromorphone) for the first time for cancer pain 2) Age 20 years or older (at the time of obtaining consent) 3) Patients who are able to take oral medications, food, and beverages 4) Patients who are considered capable of self-recording in the patient diary (proxy recording in the patient diary is acceptable if the patient is capable of self-assessment). 5) Patients who are not expected to have a rapid change in their cancer condition during the study period. 6) Patients who have received sufficient explanation and written consent of their own free will to participate in this study.
Exclusion criteria
Exclusion criteria: 1) Patients with gastrointestinal obstruction or suspected gastrointestinal obstruction, or patients with a history of gastrointestinal obstruction and a high risk of recurrence 2) Patients who have undergone surgery, radiotherapy, or procedures affecting gastrointestinal function (e.g., nerve block) within 14 days prior to the date of enrollment, or who are scheduled to undergo such procedures during the study period. 3) Patients with medically significant cardiovascular, respiratory, hepatic, or renal dysfunction based on history, clinical laboratory values, electrocardiogram, or physical examination, who are judged inappropriate to participate in the study. 4) Patients who have received or are currently receiving naldemedine medication 5) Patients who have had severe diarrhea (more than 7 times a day) or who have had a stool extraction for constipation within the past 7 days 6) Patients who have used opioid patches or injectable opioids in the past 7 days. 7) Patients who have received cancer drug therapy that is certain to affect defecation within 14 days prior to the initial enrollment date, or who are scheduled to receive such therapy within the study period. Cancer drug therapy that is certain to affect defecation will be defined as follows. 1.Initial administration of a therapeutic regimen containing irinotecan (CPT-11) 2.Other cancer drug therapy that is considered certain to affect defecation. However, the following cases may be considered as not affecting defecation a) Chemotherapy with the same regimen as the previous course or chemotherapy with the same drug and dose, and there was no moderate or greater constipation or diarrhea (CTCAE v5.0 Grade 2 or higher) during the previous course or previous chemotherapy. b) Patients who have received oral anticancer agents (e.g. TS-1) daily and have not had moderate or severe constipation or diarrhea (CTCAE v5.0 Grade 2 or higher) for at least 1 week from the start of oral chemotherapy to the start of study drug. 8) Pregnant or lactating patients 9) Patients with suspected hypersensitivity to opioid receptor antagonists such as naldemedine, naltrexone, methylnaltrexone, and naloxone. 10) Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for participation in the study based on concomitant therapy or medical findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with a Bowel Function Index of less than 28.8 on Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Percentage of patients with a Bowel Function Index of less than 28.8 on Day 7 2) Amount and rate of change in Bowel Function Index from Day 1 on Day 7 and 14 3) Percentage and number of patients with Spontaneous Bowel Movement of 3 or more per week on Day 7 and 14 4) Percentage and number of patients with Complete Spontaneous Bowel Movement (CSBM: spontaneous bowel movement without urgency or residual defecation) of 3 or more per week on Days 7 and 14 5) Bowel movements during defecation (yes/no), squeezing during each defecation (not at all/just a little/moderately/quite a lot/very much), residual feeling during each defecation (yes/no) 6) Overall bowel movements (4 levels: dissatisfied, somewhat dissatisfied, somewhat satisfied, satisfied) in the last week on Day 1, 7, and 14, and changes in bowel movements between Day 1 and Day 7 and between Day 1 and Day 14 7) PAC-SYM and PAC-QOL for Day 1 and 14 8) EORTC QLQ-C15-PAL, and subscale scores for Day 1, 7, and 14 9) EORTC QLQ-C15-PAL item 10 (constipation) for Day 1, 7, and 14, with the percentages of patients who responded "a little," "a lot," "a great deal," and "a lot" or "a great deal 10) Amount of change in JPAC-QOL for Day 1 and 14 11) Amount of change in JPAC-SYM on Day 1 and 14 12) Percentage of patients who vomited at least once during the 3 days from Day 1 to Day 3 13) Percentage of patients who used antiemetic drugs during the 3 days from Day 1 to Day 3 14) Percentage of patients who responded "a little", "a lot", "very much", and "a lot" or "very much" to EORTC QLQ-C15-PAL item 9 (nausea) on Days 1, 7, and 14 15) Number of times rescue laxatives were used 16) Number of episodes of diarrhea that occurred during administration of the study drug 17) Adverse events that occurred during study drug administration 18) Double-blind validation | — |
Contacts
Public ContactHamano Jun
University of Tsukuba Hospital
Outcome results
None listed