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.

Abstract

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.

• Authors: Toru Aoyama, Satoshi Morita, Toru Kono, Taishi Hata, Hideyuki Mishima, Junichi Sakamoto
• Journal: Journal of cancer research and therapeutics (J Cancer Res Ther) 2021 Oct-Dec Vol. 17 Issue 6 Pg. 1473-1478 ISSN: 1998-4138 [Electronic] India
• PMID: 34916380 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Drugs, Chinese Herbal
• Organoplatinum Compounds
• gosha-jinki-gan
• Oxaliplatin
• Leucovorin
• Fluorouracil

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Colonic Neoplasms (drug therapy)
• Double-Blind Method
• Drugs, Chinese Herbal (administration & dosage)
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Humans
• Leucovorin (administration & dosage, adverse effects)
• Male
• Middle Aged
• Neurotoxicity Syndromes (diagnosis, drug therapy, etiology)
• Organoplatinum Compounds (administration & dosage, adverse effects)
• Oxaliplatin (administration & dosage, adverse effects)
• Prospective Studies
• Rectal Neoplasms (drug therapy)
• Treatment Outcome