goshajinkigan (TJ-107) / Tsumura - LARVOL DELTA

Preventive effect of goshajinkigan on paclitaxel-induced peripheral neuropathy: an open-label, randomized phase II study (OLCSG2101). (PubMed, Oncologist) - "GJG was associated with fewer grade ≥2 CIPN events in this predominantly lung-cancer population. Given the open-label design and uncertainty in the stratified analysis, these findings represent a phase II preventive signal warranting confirmation in a double-blind, placebo-controlled phase III trial."

Journal • P2 data • Lung Cancer • Oncology • Pain • Solid Tumor

Paclitaxel-Induced Neuropathy Prevention With Goshajinkigan in a Lung Cancer-Predominant Population: OLCSG2101 Randomized Phase II Trial (IASLC-WCLC 2026) - "Goshajinkigan (GJG), a traditional Japanese herbal medicine (Kampo), has shown neuroprotective potential in preclinical studies and a favorable signal in a randomized trial of docetaxel-induced CIPN...Methods : In this open-label, randomized phase II trial conducted by the Okayama Lung Cancer Study Group (OLCSG; trial identifier OLCSG2101), patients enrolled between April 2022 and September 2025 with pathologically confirmed malignant tumors who were scheduled to undergo at least four cycles of carboplatin plus PTX (≥150 mg/m2 every 3-4 weeks) were randomized 1:1 to arm A (GJG 7.5 g/day from cycle 1) or arm B (control without GJG)...Conclusions : In this predominantly lung cancer population, prophylactic GJG was associated with a lower incidence of clinically relevant PTX-induced CIPN, without a clear increase in severe adverse events. These findings support further evaluation of GJG in a double-blind, placebo-controlled phase III trial."

Clinical • P2 data • Lung Cancer • Oncology • Solid Tumor

Kampo medicine as a nutrition-relevant multi-target intervention for sarcopenia: implications for appetite, mitochondrial function, and the frailty-sarcopenia-cachexia continuum. (PubMed, Front Nutr) - "Several Kampo formulations, including Ninjin'yoeito, Rikkunshito, Hochuekkito, Juzentaihoto, Hachimijiogan, and Goshajinkigan, have been associated with biological or clinical domains potentially relevant to appetite regulation, oral intake, inflammatory balance, gut microbiota-related pathways, metabolic resilience, and functional support...Kampo medicine is best regarded as a hypothesis-generating, nutrition-relevant complementary approach within multimodal sarcopenia care rather than as an established stand-alone therapy for muscle loss. Future studies should use standardized diagnostic criteria, prespecified sarcopenia endpoints, rigorous safety monitoring, and transparent reporting to determine whether selected Kampo formulations can improve clinically meaningful nutrition-related and muscle-related outcomes."

Journal • Review • Anorexia • Cachexia • Fatigue • Inflammation • Metabolic Disorders • Sarcopenia

Functional prescribing patterns of 111 Kampo formulations in contemporary hospital practice: a 21-year prescription- and patient-level analysis from Japan. (PubMed, J Ethnopharmacol) - "Although the study setting was a single tertiary-care university hospital, this real-world analysis identified distinct functional prescribing patterns among major Kampo medicines and provides a comprehensive overview of Kampo utilization in contemporary Japanese hospital practice."

Journal • Women's Health

Precision Management Framework for Chemotherapy-Induced Peripheral Neuropathy (CIPN): Healthcare DX x Multidisciplinary Intervention (JBCS 2026) - "From the start of treatment, in addition to administering three types of herbal medicine (Goshajinkigan, Keishikajutsubuto, aconic acid: 2019 Japanese Breast Cancer Society General Meeting), surgical gloves are worn, and during treatment, CIPN and other adverse events (fever, respiratory symptoms, etc.) are regularly evaluated mainly using ePRO (PRO-CTCAE), and an early detection (alert) system has been introduced...This suggests the importance of not only symptomatic treatment for neuropathic pain but also identifying and intervening in modifiable exacerbating factors in CIPN management. Furthermore, the algorithm and ePRO (electronic Prosecution and Evaluation) enable standardization of evaluation and treatment, reduce the burden on healthcare providers, and suggest the potential for a precision management framework that can be deployed to other facilities."

Breast Cancer • Neuralgia • Peripheral Neuropathic Pain • Solid Tumor

Prediction of Analgesic Use After Neurotoxic Chemotherapy: A Machine Learning Study Using Japanese Claims and Health Checkup Data (MASCC-ISOO 2026) - "The primary outcome was analgesic use within 12 months after the end of chemotherapy with gabapentin, duloxetine, pregabalin, tramadol, mirogabalin, mecobalamin, or goshajinkigan, defined as three or more prescriptions of any of the medications. Conclusions Claims-based prescribing trajectories with chemotherapy intensity can moderately predict post-chemotherapy analgesic use after oxaliplatin or paclitaxel. Further research with assessments of neuropathic symptoms or functional measures is needed to develop proactive supportive care and mitigate polypharmacy."

Machine learning • Neuralgia • Pain • Peripheral Neuropathic Pain

"KAMPO UTILIZATION GUIDE FOR CANCER SUPPORTIVE CARE": FROM EVIDENCE TO PRACTICAL USE (MASCC-ISOO 2026) - "Results The guide consists of (1) General Section, describing the history, characteristics, significance, action mechanisms, technical terms, safety, and future perspectives of Kampo medicine; (2) Specific Section 1: Symptoms, covering 12 major supportive care domains: general malaise/fatigue, anorexia/nausea & vomiting, psychiatric symptoms, bone marrow suppression, oral mucositis, taste disorder, diarrhea, constipation, peripheral neuropathy, skin & nail disorder, menopausal symptoms, and edema; (3) Specific Section 2: Kampo formulas, covering 14 representative Kampo formulas: bakumondoto, daikenchuto, goreisan, goshajinkigan, hangeshashinto, hochuekkito, juzentaihoto, kamikihito, keishibukuryogan, mashiningan, ninjin'yoeito, rikkunshito, shakuyakukanzoto, and yokukansan...The columns include how to learn Kampo medicine, characteristics of various crude drugs, and Evidence Reports of Kampo Treatments, and Kampo in clinical practice guidelines. Conclusions..."

Anorexia • Constipation • Gastroenterology • Gastrointestinal Disorder • Mucositis • Oncology • Stomatitis

Effects of Integrative Approaches for the Management of Chemotherapy-Induced Peripheral Neuropathy in Colorectal Cancer Patients: A Systematic Review of Randomized Controlled Trials and Quasi-Experimental Studies. (PubMed, J Pain Res) - "Furthermore, hand-foot exercise (Number of study, N=1), massage therapy (N=2) and henna application (N=1) demonstrated significant positive effects on neuropathy (p < 0.05) immediately post-intervention, while Goshajinkigan (N=2) suggested a significant effect of prevention of worsening of CIPN instead of the improvement of CIPN symptoms (p<0.05)...Therefore, high-quality studies with larger sample sizes are required to investigate the long-term effects of integrative interventions on CIPN management in patients with CRC. : CRD42025644115."

Journal • Review • Colorectal Cancer • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor

REAL-WORLD UTILIZATION OF TRADITIONAL JAPANESE KAMPO MEDICINE AS SUPPORTIVE CARE IN PATIENTS UNDERGOING CHEMOTHERAPY (IGCS 2025) - "Twenty-eight Kampo formulations were used, with the most common being Goshajinkigan (91 cases, 47.6%), Daikenchuto (82, 42.9%), and Shakuyakukanzoto (15, 7.9%). Regarding chemotherapy regimens, 123 patients (63.4%) received TEC (paclitaxel, epirubicin, carboplatin), and 53 (27.7%) received TC... Among endometrial cancer patients who underwent chemotherapy during the study period, 339 cases were identified. Of these, 191 (56.3%) received Kampo prescriptions. The median age was 60 years (range, 28–85)."

Clinical • Real-world • Real-world evidence • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Co-treatment with Gabapentinoid and Japanese Herbal Medicine Goshajinkigan for CIPN is Associated with Longer Duration and Higher Dose of Chemotherapy. (PubMed, Adv Ther) - "Combination treatment with gabapentinoid plus GJG might prevent reductions in dose or discontinuation of chemotherapy, and might be effective for the treatment of CIPN."

Journal • Breast Cancer • Colorectal Cancer • Gastric Cancer • Oncology • Pain • Solid Tumor

Preventive and therapeutic effects of ephedrine alkaloids-free Ephedra Herb extract on paclitaxel-induced neuropathic pain. (PubMed, J Nat Med) - "Currently, there are no effective prophylactic or therapeutic drugs for the treatment of paclitaxel (PTX)-induced peripheral neuropathic pain (PTX-PNP), highlighting the urgent need for the development of effective prophylactic and therapeutic drugs. In contrast, goshajinkigan, a Kampo medicine, and diclofenac, a non-steroidal anti-inflammatory drug, showed minimal therapeutic effects on PTX-PNP. These findings demonstrate the significant potential of EFE as a novel, safe prophylactic and therapeutic agent against PTX-PNP."

Journal • Neuralgia • Oncology • Pain • Peripheral Neuropathic Pain

Effects of morroniside isolated from Cornus officinalis fruits on functional gastrointestinal disorders and gastric ulcer in mice. (PubMed, Fitoterapia) - "The dried fruits of Cornus officinalis (Cornaceae) are used in Kampo medicine (e.g. Hachimigan and Goshajinkigan) to treat senile osteoporosis, diabetes, gastric atony, frequent urination, and diarrhea/constipation associated with aging...officinalis extract, morroniside and 5-HT3 receptor antagonist (ramosetron) attenuated 5-HT-induced diarrhea...The results obtained herein suggest the potential of morroniside as an effective treatment for irritable bowel syndrome, such as diarrhea and functional dyspepsia (reductions in gastric emptying and small intestinal motility), caused by 5-HT. The present study suggests a role for morroniside in the regulation of elevations in CRF, ACTH, and corticosterone levels through hypothalamic-pituitary-adrenal axis activity induced by stress loading, such as a 5-HT treatment and/or HCl/EtOH stimulation."

Journal • Preclinical • Constipation • Diabetes • Dyspepsia • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Osteoporosis • Peptic Ulcer • Rheumatology

Effectiveness of the Traditional Japanese Medicine Goshajinkigan in Preventing Paclitaxel-Induced Peripheral Neuropathy: A Multicenter Randomized Comparative Trial. (PubMed, Integr Cancer Ther) - " This study enrolled 55 patients with ovarian cancer undergoing first-line chemotherapy using paclitaxel and carboplatin. GJG, when administered prophylactically, showed potential for mitigating CIPN symptoms during paclitaxel chemotherapy. While promising, further research with placebo controls and objective measures is essential to comprehensively validate these findings."

Clinical • Journal • Oncology • Ovarian Cancer • Pain • Solid Tumor

A randomized, open-label phase II study on the preventive effect of goshajinkigan against peripheral neuropathy induced by paclitaxel-containing chemotherapy: The OLCSG2101 study protocol. (PubMed, Respir Investig) - "The results of this study may contribute to better management of CIPN, which can enable the continuation of chemotherapy and maintenance of the patient's QOL."

Clinical • Clinical protocol • Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor • Thymus Cancer

Study of perioperative dose-dense chemotherapy at our hospital (JBCS 2024) - "The taxanes used were dose dense paclitaxel (ddPTX) in 19 patients, weekly paclitaxel (wPTX) in 31 patients, and nab-paclitaxel (nab-PTX) in 3 patients...Peripheral neuropathy is a frequent side effect of taxanes, but only two cases required dose reduction, and the rest were able to be controlled with goshajinkigan, pregabalin, and mirogabalin besilate...Conclusion Dose-dense chemotherapy showed a high completion rate and was relatively safe. Furthermore, dose-dense chemotherapy showed a high pCR rate in preoperative chemotherapy for HER2-negative breast cancer, and is considered to be an effective treatment"

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Pain • Solid Tumor • Triple Negative Breast Cancer • HER-2

CANCER SUPPORT CLINIC USING KAMPO MEDICINE (MASCC-AFSOS-ISOO 2024) - "Goshajinkigan (TJ-107) was used for paclitaxel-induced PN, and ninjin'yoeito (TJ-108) was used for oxaliplatin-induced PN. Other symptoms (and Kampo prescription) included niraparib-induced nausea & vomiting in a patient with recurrent ovarian cancer (heiisan, TJ-79), multiple pain (not due to metastasis) in a postoperative patient with breast cancer (goshakusan, TJ-63), and oral mucositis in a patient with recurrent non-small cell lung cancer (hangeshashinto, TJ-14). In some patients, a single Kampo prescription effectively ameliorated multiple symptoms, indicating a potential polypharmacy solution. Conclusions Kampo medicines, high-quality pharmaceutical products, have been well applied in cancer support clinic in Japan."

Anorexia • Breast Cancer • Lung Cancer • Mucositis • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pain • Peripheral Neuropathic Pain • Sarcopenia • Solid Tumor • Stomatitis

The Role Of Diet And Non-pharmacologic Supplements In The Treatment Of Chronic Neuropathic Pain: A Systematic Review (ASA 2023) - "The CIPN studies used various interventions including goshajinkigan (4 studies), vitamin E (5), vitamin B12 (3), glutamine (3), N-acetyl-cysteine (2), acetyl-L-carnitine (2), guilongtonluofang (1), ninjin'yoeito (1), alpha-lipoic acid (1), L-carnosine (1), magnesium and calcium (1), crocin (1) and antioxidants (1), with some studies involving multiple interventions... Based on the review, we cannot recommend any supplement use for the management of CIPN, although further research into N-acetyl-cysteine, L-carnosine, crocin and magnesium is warranted. Acetyl-L-carnitine was found to be likely ineffective or harmful. Alpha-lipoic acid was not found effective."

Review • Diabetic Neuropathy • Musculoskeletal Pain • Neuralgia • Oncology • Pain • Peripheral Neuropathic Pain

Efficacy and safety of drug therapy for the prevention and treatment of chemotherapy-induced peripheral neuropathy: a protocol for a systematic review and network meta-analysis. (PubMed, BMJ Open) - "We will include studies that investigated the efficacy and safety of vitamin B, goshajinkigan, non-steroidal anti-inflammatory analgesics, opioids, calcium and magnesium, antidepressants and anticonvulsants on CIPN...The research will be published in a peer-reviewed journal. CRD42022371829."

Journal • Retrospective data • Review • Oncology • Pain

The role of diet and non-pharmacologic supplements in the treatment of chronic neuropathic pain: A systematic review. (PubMed, Pain Pract) - "Based on the review, we cannot recommend any supplement use for the management of CIPN, although further research into N-acetyl-cysteine, l-carnosine, crocin, and magnesium is warranted. Acetyl-l-carnitine was found to be likely ineffective or harmful. Alpha-lipoic acid was not found effective. Studies with goshajinkigan, vitamin B12, vitamin E, and glutamine had conflicting results regarding efficacy, with one goshajinkigan study finding it harmful. Guilongtonluofang, ninjin'yoeito, and antioxidants showed various degrees of potential effectiveness. Regarding DPN, our review supports the use of alpha-lipoic acid, acetyl-l-carnitine, and vitamin D. The early use of vitamin C prophylaxis for the development of CRPS-I also seems promising. Further research is warranted to confirm these findings."

Journal • Review • Diabetic Neuropathy • Musculoskeletal Pain • Neuralgia • Oncology • Pain • Peripheral Neuropathic Pain

Efficacy and safety of dose-dense neoadjuvant chemotherapy with nab-paclitaxel followed by epirubicin and cyclophosphamide for operable breast cancer. (PubMed, Jpn J Clin Oncol) - "Neoadjuvant dose-dense biweekly nanoparticle albumin-bound paclitaxel followed by dose-dense epirubicin and cyclophosphamide was effective, especially in patients with triple-negative disease, and feasible with pegfilgrastim support."

Journal • Breast Cancer • Fatigue • Febrile Neutropenia • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor • Triple Negative Breast Cancer • HER-2

Preventive effect of goshajinkigan against peripheral neuropathy induced by paclitaxel-containing chemotherapy: An open-label, randomized, phase II study. (ASCO 2022) - " Patients have to meet the followings: pathologically diagnosed with malignant tumor (regardless of cancer type) and scheduled to receive ≥4 courses of chemotherapy including carboplatin and paclitaxel (paclitaxel ≥150mg/m2 every 3-4 weeks) as initial chemotherapy; age ≥20yrs; Performance Status of 0 or 1. The secondary endpoint includes time to the onset of CIPN G2, incidence rate and severity of CIPN at the end of each course, relative dose intensity of paclitaxel, adverse events other than CIPN. Enrollment began in 2022, and will be complete by 2025."

Clinical • P2 data • Diabetic Neuropathy • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor

Behavioral and Immunohistochemical Evidence for Suppressive Effects of Goshajinkigan on Salicylate-Induced Tinnitus in Rats. (PubMed, Brain Sci) - "The analysis of c-Fos expression in auditory-related brain areas revealed that GJG significantly reduced the salicylate-induced increase in the number of c-Fos-expressing cells in the auditory cortices, inferior colliculus, and dorsal cochlear nucleus. These results suggest a suppressive effect of GJG on salicylate-induced tinnitus in animal models."

Journal • Preclinical • Otorhinolaryngology • Palliative care • FOS

NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: Hyunseok Kang, MD; Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Dietary Supplements in Chemotherapy-Induced Peripheral Neuropathy: A New Hope? (PubMed, Nutrients) - "As proposed, acetyl-L-carnitine, vitamins (group B and E), extracts of medical plants, including goshajinkigan, curcumin and others, unsaturated fatty acids, as well as the diet composed of so-called "sirtuin-activating foods", could change the typical way of treatment of CIPN, improve the quality of life of patients and maintain the continuity of chemotherapy. This review summarizes currently available data regarding mentioned above agents and evaluates the rationale behind future research focused on their efficacy in CIPN."

Journal • Review • Oncology • Pain

Kampo medicines for supportive care of patients with cancer: A brief review. (PubMed, Integr Med Res) - "Potential use of rikkunshito for anorexia/cancer cachexia and goshajinkigan for peripheral neuropathy is proposed from small numbers of randomized controlled trials in addition to basic research...Kampo medicines potentially play some roles in preventing or ameliorating side effects of anticancer agents. Supportive care with Kampo medicines for patients with cancer might lead to physical, mental, and nutritional improvement."

Journal • Review • Anorexia • Cachexia • Fatigue • Oncology • Pain