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Poster lunch

966 - Randomized Phase II Study of TJ-54 (Yokukansan) for postoperative delirium in gastrointestinal and lung malignancy patients (515P)

Date

18 Nov 2017

Session

Poster lunch

Presenters

Junya Morita

Citation

Annals of Oncology (2017) 28 (suppl_10): x155-x165. 10.1093/annonc/mdx676

Authors

J. Morita1, T. Aoyama1, N. Sugano1, T. Sato1, S. Amano1, T. Nagashima1, Y. Ishikawa1, M. Taguri2, T. Yamanaka2, Y. Yamamoto1, T. Oshima1, N. Yukawa1, Y. Rino1, M. Masuda1

Author affiliations

  • 1 Department Of Surgery, Yokohama City University, 236-0004 - Yokohama/JP
  • 2 Department Of Biostatistics, Yokohama City University, 236-0004 - Yokohama/JP
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Resources

Abstract 966

Background

We evaluated the efficacy and safety of TJ-54 (Yokukansan; a traditional Japanese medicine [Kampo]) for the prevention and/or treatment of postoperative delirium in a randomized phase II trial of patients receiving surgery for gastrointestinal and lung malignancies.

Methods

Patients ≥70 years of age who underwent surgery for gastrointestinal or lung malignancy were eligible for this study. The 186 eligible patients were randomly assigned at a 1:1 ratio to receive TJ-54 or control during their perioperative care (between day 7 before surgery and day 4 after surgery, except for the operation day). The signs and symptoms of delirium were assessed using the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV by the investigator during the perioperative period.

Results

We analyzed 186 eligible gastrointestinal or lung malignancy patients (TJ-54; 93, control; 93). There were no marked differences between the two randomized groups. The incidence of delirium was 6.5% (6 patients) in the TJ-54 group and 9.7% (9 patients) in the control group, with no significant difference (p = 0.419). However, among the patients who were MMSE ≤ 26, the incidence of postoperative delirium was 9.1% in the TJ-54 group and 26.9% in the control group (risk ratio: 0.338; 95% confidence interval [0.078-1.462], p = 0.115). Treatment with TJ-54 tended to reduce the incidence of postoperative delirium compared with the control group.

Conclusions

Although TJ-54 did not demonstrate any contribution to preventing or treating postoperative delirium in patients following surgery for gastrointestinal or lung malignancy, TJ-54 tended to reduce the risk of postoperative delirium in the patients who were MMSE ≤ 26. Further phase III studies with a larger sample size are needed to clarify the effects of TJ-54 against postoperative delirium.

Clinical trial identification

UMIN000005423.

Legal entity responsible for the study

Toru Aoyama

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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