Effects of Goshajinkigan (TJ-107) for oxaliplatin-induced peripheral neurotoxicity using the functional assessment of cancer therapy/gynecologic oncology group 12-item neurotoxicity questionnaire in a Phase II, multicenter, randomized, double-blind, placebo-controlled trial
Toru Aoyama1, Satoshi Morita2, Toru Kono3, Taishi Hata4, Hideyuki Mishima5, Junichi Sakamoto6
1 Department of Surgery, Yokohama City University, Yokohama, Japan
2 Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan
3 Advanced Surgery Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan
4 Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan
5 Cancer Center, Aichi Medical University, Nagakute, Japan
6 Director of a Hospital, Tokai Central Hospital, Kakamigahara, Japan
Department of Surgery, Yokohama City University, 3.9 Fukuura, Kanazawa.Ku, Yokohama 236.0004
Source of Support: None, Conflict of Interest: None
Background: The aim of the present study was to evaluate the efficacy of TJ-107 for oxaliplatin-induced peripheral neurotoxicity in prospective, multi-institutional, randomized, double-blind, placebo-controlled Phase II trials using the functional assessment of cancer therapy/gynecologic oncology group 12-item neurotoxicity questionnaire (FACT-GOG-NTX-12).
Patients and Methods: The patients who were registered to the Goshajinkigan oxaliplatin neurotoxicity evaluation study (UMIN000002211) were analyzed. A NTX-12 from the validated FACT/GOG-NTX-12 was assessed before treatment and at the end of every 2 cycles.
Results: The comparisons of the median scores for TJ-107 and the placebo at 8 and 26 weeks were as follows: numbness or tingling in the hands (P = 0.5820), numbness or tingling in the feet (P = 0.3236), feeling of discomfort in the hands (P = 0.8219), feeling of discomfort in the feet (P = 0.5361), joint pain or muscle cramps (P = 0.1974), feeling weak all over (P = 0.2771), trouble hearing (P = 0.2832), ringing or buzzing in ears (P = 0.1031), trouble buttoning buttons (P = 0.1653), trouble feeling the shape of small objects when held in hand (P = 0.2919), trouble walking (P = 0.5406), and pain in the hands or feet when exposed to cold temperatures (P = 0.1872).
Conclusion: There might be no clinically significant difference between the use of TJ-107 and the severity and quality of life for patients treated with oxaliplatin.