PD787 - EFFECTS OF NINJIN’YOEITO ON NUTRITIONAL STATUS AND QUALITY OF LIFE IN PATIENTS WITH METASTATIC COLORECTAL CANCER RECEIVING CHEMOTHERAPY

PD787

EFFECTS OF NINJIN’YOEITO ON NUTRITIONAL STATUS AND QUALITY OF LIFE IN PATIENTS WITH METASTATIC COLORECTAL CANCER RECEIVING CHEMOTHERAPY

K. Shinozaki^1,*, Y. Motoo², T. Takagi³, N. Yoshida⁴, S. Ito⁵, Y. Munemoto⁶, T. Nishiuchi⁷, Y. Negoro⁸, H. Fujita⁹, Y. Shindo¹⁰, E. Baba¹¹, H. Arai¹², M. Miura¹³, S. Morita¹⁴, A. Tsuji¹⁵

¹Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, ²Department of Internal Medicine and Multidisciplinary Cancer Centre, Fukui-ken Saiseikai Hospital, Fukui, ³Department of Surgery, Nishijin Hospital, ⁴Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, ⁵Department of Surgery, Shonan Kamakura General Hospital, Kamakura, ⁶Department of Surgery, Fukui-ken Saiseikai Hospital, Fukui, ⁷Department of Medical Oncology, Takamatsu Red Cross Hospital, Takamastu, ⁸Department of Oncological Medicine, Kochi Health Sciences Centre, Kochi, ⁹Department of General and Digestive Surgery, Kanazawa Medical University, Kahoku, ¹⁰Department of Gastroenterological Surgery, Nakadori General Hospital, Akita, ¹¹Department of Comprehensive Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, ¹²Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, ¹³Department of Pharmacy, Akita University Hospital, Akita, ¹⁴Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, ¹⁵Department of Clinical Oncology, Kagawa University Faculty of Medicine, Kita-gun, Japan

Rationale: Cancer-associated malnutrition during chemotherapy impairs quality of life (QoL) and treatment tolerance. We evaluated whether Ninjin’yoeito (NYT) improves nutritional status and QoL in patients with metastatic colorectal cancer (mCRC).

Methods: This multicentre, open-label, randomised phase II trial enrolled patients with unresectable mCRC receiving first-line capecitabine plus oxaliplatin (CAPOX) with bevacizumab. Patients were randomly assigned (1:1) to NYT plus chemotherapy or chemotherapy alone. Nutritional status was assessed using the Controlling Nutritional Status (CONUT) score and categorised as improvement/maintenance or deterioration. QoL was evaluated using the EORTC QLQ-C30. Between-group comparisons were performed using Fisher’s exact test and mixed-effects models.

Results: A total of 74 patients were analysed (NYT, n=39; control, n=35). Based on CONUT-defined nutritional status, deterioration occurred in 12/39 (30.8%) patients in the NYT group and 13/33 (39.4%) in the control group, with no significant difference between groups (p=0.470). The incidence of grade ≥3 non-haematological adverse events was similar (25.6% vs. 20.0%; p=0.593). In contrast, BMI was significantly better maintained in the NYT group (p=0.007). The NYT group also showed significantly improved QoL, including higher social functioning (p=0.009) and lower appetite loss (p=0.011) and constipation (p=0.024).

Conclusion: Although NYT did not significantly affect CONUT-defined nutritional deterioration or severe toxicity, it was associated with better maintenance of body weight and improvements in selected QoL domains. Further studies are warranted to confirm these findings.

Disclosure of Interest: K. Shinozaki: None declared, Y. Motoo Speakers Bureau of: Tsumura & Co., T. Takagi: None declared, N. Yoshida: None declared, S. Ito Speakers Bureau of: Tsumura & Co., Y. Munemoto: None declared, T. Nishiuchi: None declared, Y. Negoro: None declared, H. Fujita: None declared, Y. Shindo: None declared, E. Baba: None declared, H. Arai: None declared, M. Miura: None declared, S. Morita: None declared, A. Tsuji: None declared