Opioid-induced Constipation in Patients with Cancer Pain in Japan (OIC-J Study): Patients’ Self-Assessment of the Symptoms and the Impact

Date 24 November 2018
Event ESMO Asia 2018 Congress
Session Poster display - Cocktail
Topics Supportive Measures
Palliative Care
Presenter Toshio Noriyuki
Citation Annals of Oncology (2018) 29 (suppl_9): ix129-ix138. 10.1093/annonc/mdy444
Authors T. Noriyuki1, H. Imai2, S. Fumita3, T. Harada4, M. Gamoh5, Y. Akashi3, H. Sato6, Y. Kizawa7, A. Tokoro8
  • 1Department Of Surgery, Onomichi General Hospital, 722-8508 - Onomichi/JP
  • 2Division Of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota/JP
  • 3Department Of Medical Oncology, Kindai University Nara Hospital, Ikoma/JP
  • 4Center For Respiratory Diseases, JCHO Hokkaido Hospital, 062-8618 - Sapporo/JP
  • 5Department Of Medical Oncology, Osaki Citizen Hospital, 989-6183 - Osaki/JP
  • 6Global Medical Affairs, Shionogi, 530-0012 - Osaka/JP
  • 7Department Of Palliative Medicine, Kobe University Graduate School of Medicine, Kobe/JP
  • 8Department Of Psychosomatic Internal Medicine And Supportive And Palliative Care Team, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai/JP



Opioid-Induced Constipation (OIC) is a common side effect of opioid analgesic therapy. Previously we reported the OIC incidence of cancer patients using Rome IV criteria as the primary outcome of OIC-J Study. This analysis evaluated a patients’ self-awareness of OIC and the burden of OIC.


This study was a multicenter, prospective, observational study of cancer patients who started opioid therapy in Japan (UMIN000025864). Incidence of OIC for 2 weeks from the start of opioid therapy was evaluated both daily by patients’ daily self-assessment and weekly by Rome IV criteria based on the record of each bowel movement (BM) in patient diary. Treatments for constipation were allowed during the study period. Degree of satisfaction and important aspects for OIC treatment, the influence of OIC for pain management, and communication between patients and healthcare professionals were evaluated by questionnaires for health care provider (HCP) and patients.


In total, 212 cancer patients (145 males; mean age 69.1 years) were included in the study. Onset of OIC based on patients’ self-assessment was relatively rapid; 30.2% (64/212) reported OIC by Day 3, 43.5% (91/212) by Day 7, and 47.6% (101/212) by Day 14. Accumulated proportion of OIC for 2 weeks by patients’ self-assessment was slightly lower than that by Rome IV criteria (47.6% vs 56.1%). The symptoms that made patients feel constipated were decreased number of BMs (71/99, 71.7%), and symptoms of BM (eg, straining, hard stools, sensation of incomplete evacuation; 46/99, 46.5%). Although satisfaction level of OIC treatment was high for both patients and HCPs (proportion of ‘very satisfied’ or ‘satisfied’; patients 79.5%, physicians 75.4%, nurses 76.4%), about half of patients (53.6%), physicians (42.3%), and nurses (36.8%) reported their pain management was ‘much affected’ or ‘affected’ by OIC. Most patients and HCPs reported that OIC conditions were ‘sufficiently/essentially communicated’.


Patients recognize the onset of OIC in very early period of opioid therapy and the impact of OIC on pain management was also recognized among both patients and HCPs. This suggests that treating OIC early is warranted for effective pain management.

Editorial acknowledgement

Clinical trial identification


Legal entity responsible for the study

Shionogi & Co., Ltd.


Shionogi & Co., Ltd.


T. Harada: Honoraria: Taiho Pharmaceutical, AstraZeneca K.K., Boehringer Ingelheim, Hisamitsu Pharmaceutical Co., Inc. H. Sato: Employee: Shionogi Co., Ltd. All other authors have declared no conflicts of interest.