PMID- 30030317
OWN - NLM
STAT- MEDLINE
DCOM- 20191022
LR  - 20191022
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 8
IP  - 7
DP  - 2018 Jul 19
TI  - Efficacy of oral administration of cystine and theanine in patients with 
      colorectal cancer undergoing capecitabine-based adjuvant chemotherapy after 
      surgery: study protocol for a multi-institutional, randomised, double-blinded, 
      placebo-controlled, phase II trial.
PG  - e021442
LID - 10.1136/bmjopen-2017-021442 [doi]
LID - e021442
AB  - INTRODUCTION: Although adjuvant capecitabine therapy for patients with colorectal 
      cancer after surgery often causes adverse events (AEs), such as diarrhoea, 
      stomatitis, anorexia and hand-foot syndrome (HFS), there are no standard 
      prevention therapies. Cystine and theanine were reported to attenuate some 
      chemotherapy-associated AEs, and are also expected to attenuate the AEs caused by 
      capecitabine treatment. Therefore, our present study aimed to determine the 
      safety and efficacy of cystine/theanine therapy in patients with colorectal 
      cancer undergoing capecitabine-based adjuvant chemotherapy after surgery. METHODS 
      AND ANALYSIS: A multi-institutional, prospective, randomised, double-blinded, 
      placebo-controlled, phase II trial is being planned. Patients with colorectal 
      cancer treated with capecitabine as an adjuvant chemotherapy will be randomised 
      into either the cystine/theanine group (n=50) or placebo group (n=50). Data will 
      be collected during four courses of capecitabine therapy. The primary endpoint 
      will be incidence rate of diarrhoea of grade 1 or higher in accordance with the 
      Common Terminology Criteria for AEs (CTCAE) v.4.0, Japanese Clinical Oncology 
      Group (JCOG) version. The secondary endpoints are incidence rates of other AEs 
      (CTCAE v.4.0-JCOG), scores of the Japanese version of the European Organisation 
      for Research and Treatment of Cancer Quality of Life Questionnaire module for all 
      patients with cancer (QLQ-C30) and for patients with colorectal cancer 
      (QLQ-CR29), incidence rate of HFS according to the HFS grading scale, protocol 
      adherence, completion rate of four courses of capecitabine therapy and the 
      proportion of completion without delay or dose reduction, time to completion of 
      four courses of capecitabine and total dose of capecitabine. A sample size of 100 
      patients will be analysed between November 2016 and April 2018. ETHICS AND 
      DISSEMINATION: Ethical approval was obtained at all participating institutions. 
      The results of this study will be submitted for publication in international 
      peer-reviewed journals. TRIAL REGISTRATION NUMBER: UMIN000024784; Pre-results.
CI  - (c) Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Hamaguchi, Reo
AU  - Hamaguchi R
AD  - Department of Palliative Medicine, The Institute of Medical Science, The 
      University of Tokyo, Tokyo, Japan.
FAU - Tsuchiya, Takashi
AU  - Tsuchiya T
AD  - Department of Gastroenterological Surgery, Sendai City Medical Center Sendai Open 
      Hospital, Sendai, Japan.
FAU - Miyata, Go
AU  - Miyata G
AD  - Department of Gastroenterological Surgery, Iwate Prefectural Central Hospital, 
      Iwate, Japan.
FAU - Sato, Toshihiko
AU  - Sato T
AD  - Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.
FAU - Takahashi, Kenichi
AU  - Takahashi K
AD  - Department of Colorectal Surgery, Tohoku Rosai Hospital, Sendai, Japan.
FAU - Ariyoshi, Keisuke
AU  - Ariyoshi K
AD  - Department of Palliative Medicine, The Institute of Medical Science, The 
      University of Tokyo, Tokyo, Japan.
AD  - Japanese Organisation for Research and Treatment of Cancer (JORTC), NPO, Tokyo, 
      Japan.
FAU - Oyamada, Shunsuke
AU  - Oyamada S
AD  - Japanese Organisation for Research and Treatment of Cancer (JORTC), NPO, Tokyo, 
      Japan.
FAU - Iwase, Satoru
AU  - Iwase S
AD  - Department of Palliative Medicine, The Institute of Medical Science, The 
      University of Tokyo, Tokyo, Japan.
LA  - eng
SI  - UMIN-CTR/UMIN000024784
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180719
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0 (Glutamates)
RN  - 48TCX9A1VT (Cystine)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - 8021PR16QO (theanine)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Antimetabolites, Antineoplastic/*therapeutic use
MH  - Capecitabine/*therapeutic use
MH  - *Chemotherapy, Adjuvant
MH  - *Clinical Trials, Phase II as Topic
MH  - Colorectal Neoplasms/*drug therapy/mortality/surgery
MH  - Cystine/*administration & dosage
MH  - Disease-Free Survival
MH  - Double-Blind Method
MH  - Female
MH  - Glutamates/*administration & dosage
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Multicenter Studies as Topic
MH  - *Randomized Controlled Trials as Topic
MH  - Treatment Outcome
PMC - PMC6059283
OTO - NOTNLM
OT  - adjuvant chemotherapy
OT  - adverse events
OT  - capecitabine
OT  - colorectal cancer
OT  - cystine and theanine
OT  - hand-foot syndrome
COIS- Competing interests: None declared.
EDAT- 2018/07/22 06:00
MHDA- 2019/10/23 06:00
PMCR- 2018/07/19
CRDT- 2018/07/22 06:00
PHST- 2018/07/22 06:00 [entrez]
PHST- 2018/07/22 06:00 [pubmed]
PHST- 2019/10/23 06:00 [medline]
PHST- 2018/07/19 00:00 [pmc-release]
AID - bmjopen-2017-021442 [pii]
AID - 10.1136/bmjopen-2017-021442 [doi]
PST - epublish
SO  - BMJ Open. 2018 Jul 19;8(7):e021442. doi: 10.1136/bmjopen-2017-021442.