NIPH Clinical Trials Search

Phase II study of lubiprostone for chemotherapy-induced constipation in patients with lung cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	primary lung cancer
Date of first enrollment	2016/04/14
Target sample size	37
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	oral lubiprostone 24mcg BID

Outcome(s)

Primary Outcome

Change from screening period in bowel movements (BMs) frequency at week first after starting lubiprostone without rescue medication use

Secondary Outcome

Changes from screening period in BMs frequency at week 2 or more after starting lubiprostone without rescue medication use Time to first BMs without rescue medication use Percentage of patients with their first BMs within 24 and 48 hours after the dosage without rescue medication use Changes from screening period of each parameter and total score in Constipation Scoring System Change of the hardness in BMs (Bristol Stool Scale) Time to first rescue medication use (Time to treatment failure) Adverse Events

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria	Primary inclusion criteria 1) Histologically or cytologically confirmed lung cancer 2) First course or after second course chemotherapy or chemoradiotherapy including cytotoxic anticancer agent (Regardless of untreated or treated, before or after start of the regimen) 3) Aged 20 years or over 4) ECOG Performance Status 0-2 5) Keep a diary by oneself, and ability to answer a writing by oneself-style question paper 6) Adequate organ function, as - Neutro. > or = 1,500/mm3 - Hemoglobin > or = 8.0g/dL - Plt > or = 7.5x10,000/mm3 - AST/ALT < or = 100 IU/L - T-bil < or = 1.5mg/dL - Cre < or = 1.5mg/dL - SpO2(Room air)> or = 90% 7) Life expectancy more than 3 months 8) Orally-available 9) Previously not received lubiprostone 10) Written informed consent from the patients Secondary inclusion criteria 1) After starting chemotherapy of the primary registration, there is no BM more than three days, or there is a feeling of remaining BM even if there is a BM every day, and 2 or less in Bristol Stool Scale 2) Chemotherapy or chemoradiotherapy after the second registration and the primary registration are equivalence regimens
Exclude criteria	Primary exclusion criteria 1) Only molecular target based agent (EGFR-TKI, ALK-TKI, VEGF inhibitor, immunotherapy) 2) Brain metastases with symptomatic or required for steroid and anticonvulsant 3) Mechanical bowel obstruction (e.g., tumor, hernia) or organic disorder of the large or small bowel (e.g., obstruction, stenosis, inflammatory bowel disease) 4) Megacolon or Pseudo intestinal obstruction 5) Gastrointestinal or abdominal surgery for three months before registration 6) Severe complications (e.g., uncontrollable peptic ulcer, angina pectoris, cardiovascular disease, or infection) 7) Starting opioid within two weeks before primary registration 8) History of severe drug allergy 9) Inappropriate for this study judged by the attending doctor Secondary exclusion criteria 1) Discontinuation of equivalence regimens for severe adverse events, except for dose reduction 2) Mechanical bowel obstruction (e.g., tumor, hernia) or organic disorder of the large or small bowel (e.g., obstruction, stenosis, inflammatory bowel disease) 3) Severe complications (e.g., uncontrollable peptic ulcer, angina pectoris, cardiac disease, or infection) 4) Starting opioid within two weeks before secondary registration 5) Inappropriate for this study judged by the attending doctor