NIPH Clinical Trials Search

JRCT ID: jRCT2041210101

Registered date:19/11/2021

A placebo-controlled, double-blind crossover study investigating the ameliorative effect of shakuyakukanzoto on paclitaxel (Tri-weekly)-induced muscle pain and arthralgia

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedMalignant tumors for which paclitaxel is indicated
Date of first enrollment03/12/2021
Target sample size26
Countries of recruitment
Study typeInterventional
Intervention(s)Crossover administration of Shakuyakukanzoto and placebo is conducted in the second and the third course of paclitaxel. Shakuyakukanzoto 2.5 g or placebo 2.5 g is administrated 3 times a day before meal or between meals from day 1 to day 7 of each course.


Primary OutcomeComparison between maximum pain scale of placebo from day 3 to day 5 and pain scale of shakuyakukanzoto on the corresponding day.
Secondary Outcome1) Parallel comparison of pain scale between shakuyakukanzoto and placebo on the second course of paclitaxel. 2) Amount of change of VAS, NRS, VRS, and FRS compared between shakuyakukanzoto and placebo. The timing of the evaluation is the same as that of the primary outcome. (VAS Visual analogue scale, NRS Numerical rating scale, VRS Verbal rating scale, FRS Facial rating scale) 3) The prevalence and the pattern of myalgia and arthralgia on the first, the second, and the third course of paclitaxel. 4) Medication adherence of shakuyakukanzoto.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria[Inclusion Criteria at Provisional Registration] (1) Who plans paclitaxel administered tri-weekly. (2) The age at the date of consent acquisition is 20 years or older (3) The patient's written consent to participate in the study has been obtained. (4) Patients that can be expected to survive for 12 weeks or more . (5) Performance Status (ECOG scale) is 0-2 (6) Who have never been treated with chemotherapy including paclitaxel previously. [Inclusion Criteria at Main Registration] (1) Who experienced myalgia or arthralgia above 2 with the pain scale for myalgia or arthralgia during the screening period. (2) Patients in which treatment of paclitaxel can be continued at least 2 courses from the main registration (First course to 3rd course treatment of paclitaxel is mandatory) (3) Patients who can be taken oral administration (4) Patients who meets the all inclusion criteria of provisional registration at the time of main registration and do not conflict with any of the "exclusion criteria"
Exclude criteriaPatients who meet any criterion bellow are excluded from provisional or main registration. (1) Brain metastasis or suspected brain metastasis *1 (2) Pleural effusion, ascites, or pericardial fluid which needs treatment. (3) Double cancer except for recovered past cancer (4) Severe allergic or hypersensitive conditions for any drug (5) Hypertension above 170/110 mmHg (6) Severe interstitial pneumoniae, pulmonary fibrosis, or severe COPD (7) Severe comorbidity such as ileus, diabetes mellitus (HbA1c 10.0% and above), heart failure, kidney diseases (serum Cr 1.5 mg/dL and above), liver diseases (AST and/or ALT more than 3 times standard value), or severe heart diseases *3 (8) Current thrombosis or embolism (9) Current or past stroke except for asymptomatic lacunar infarction (10) Patients who is taking loop diuretic, thiazido, or any other drug containing shakuyaku, paeoniflorin, kanzo, or glycyrrhizic acid. (11) Serum potassium level below 3.5 mEq/L (12) Aldosteronism (13) Myalgia or arthralgia caused by other diseases *4 (14) Myopathy (15) Mental disorders which matter clinically (16) Patients who have taken shakuyakukanzoto previously. (17) Pregnant, lactating, or women with a positive pregnancy test (serum human chorionic gonadotropin (hCG) test).However, pregnancy tests are not required for women undergoing sterilization, women who have had their uterus or both ovaries removed, and women who have been amenorrhea for more than a year without any other medical reason. (18) Patients (male and female) who do not consent to contraception during the period from the acquisition of consent to the end of the clinical trial, or who do not agree to contraception for a period of 6 months or more from the end of the clinical trial as directed by the principal investigator (subinvestigator). (19) Other patients who are judged by the principal investigator to be inappropriate for participation in the study safely. *1 If there are no symptoms, registration is possible even if the presence or absence of brain metastasis has not been confirmed by imaging examination. . However, asymptomatic patients who show brain metastasis in any imaging examination are excluded. *2 The eligibility of the cases with interstitial pneumoniae is judged from the estimation of the risk of worsening due to the drug based on the area of the fibrosis and whether the UIP pattern exists or not. The radiation pneumonitis without symptom is eligible. *3 For example, symptomatic coronary artery diseases, uncontrolled arrhythmia, and myocardial infarction within 12 months. *4 For example, neurologic or muscular diseases which cause chronic or unexpected pain, such as rheumatoid arthritis, guillain-barre syndrome, or chronic inflammatory demyelinating polyneuropathy.

Related Information


Public contact
Name Tsuyoshi Teramoto
Address 2630 Sugitani, Toyama, Toyama Toyama Japan 9300194
Telephone +81-76-434-7154
Affiliation Toyama University Hospital
Scientific contact
Name Akitoshi Nakashima
Address 2630 Sugitani, Toyama, Toyama Toyama Japan 9300194
Telephone +81-76-434-7357
Affiliation Toyama University Hospital