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)

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) - Examination of prevention of hand-foot syndrome in Capecitabine therapy by the prophylactic administration of Eppikajutsutou

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005899

Enrollment

Registered

2011-07-01

Start date

2011-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Capecitabine + Eppikajutsutou group One course of Capecitabine: Daily oral administration of Capecitabine (Xeloda) dose according to the body surface area twice a day for 14 days within 30 minutes af

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Capecitabine therapy patient after resection of colorectal cancer 1)histologically proven colorectal carcinoma and the clinical stage3 2)The radical cure lymphnode dissection (D2 or D3) is done. 3)tumor located in the cecum, ascending colon, transverse colon, descending colon, sigmoid colon, rectosigmoid colon, or upper rectum, and the distal edge of tumor is above the peritoneal reflection. 4)age 20< =and >=80 years 5)Performance Status(ECOG) is 0-1. 6)An advanced trouble is not provided as the main internal organs function (Fill everything the following with the inspection within 14 days before it registers). (1)White blood cell count >=3,000/mm3 and <=12,000/ mm3 (2)Platelet number >=100,000/ mm3 (3) Hemoglobin >= 9.0 g/dl (4) AST(GOT) ALT(GPT) <= facilities standard value upper bound *2.5 (5)Serum total bilirubin <= 1.5 mg/dl(6)Serum creatinine <= 1.5 mg/dl 7)Provided written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Incidence rate of hand-foot syndrome of Grade2 or more	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Japan

Contacts

Public ContactMitsuyoshi Ota

Yokohama City University Medical Center Gastroenterological center

m_ota@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026