Chinese medicine in postoperative adjuvant chemotherapy (Capecitabine therapy) for colorectal cancer: Examination of prevention of hand-foot syndrome by the prophylactic administration of Eppikajutsutou (clinical phase II study)

Phase 2

• Conditions: Colorectal cancer

• Registration Number: JPRN-UMIN000005899
• Lead Sponsor: Yokohama City University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1) severe hypersensitivity 2) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 3) The infectious disease of briskness 4) severe mental disease 5) continuous systemic steroid therapy 6) pregnant or lactating women 7) severe concomitance disease (Interstitial pneumonia, Lung fibrosis, Intestinal paralysis, Intestinal obstruction, uncontrolled Diabetes, Liver cirrhosis or Chronic hepatitis (B type and C type), etc.) 8) organ transplant patient 9) Neoadjuvant therapy (chemotherapy, radiation therapy, and hormone treatment, etc.) 10) colostomy (temporarily contained) 11) Postoperative complications do not recover. 12) remarkable perspiration tendency 13) cardiac dysfunction or cardiac infarction within six months 14) severe hypertension 15) severe renal dysfunction 16) Dysuria 17) Hyperthyroidism 18) improper as patient of clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of hand-foot syndrome of Grade2 or more

Secondary Outcome Measures

Name	Time	Method
1) Capecitabine therapy completion rate 2) Hand-and-foot syndrome (Palmar-plantar erythrodysesthesia syndrome) incidence ratio (each course Grade) 3) Time until hand-and-foot syndrome of Grade2 or more appearing 4) Capecitabine interruption (interruption frequency and total dosage/schedule dosage)5) Incidence ratios of an adverse event other than hand-and-foot syndrome (frequency and level of adverse event