UMIN-CTR Clinical Trial

Public title

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)

Acronym

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

Scientific Title

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)

Scientific Title:Acronym

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

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the hand-foot syndrome controlling effect by the prophylactic administration of Eppikajutsutou for the patient of postoperative adjuvant Capecitabine therapy (B method) by randomized controlled study with vitamin B6

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Incidence rate of hand-foot syndrome of Grade2 or more

Key secondary outcomes

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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 after the breakfast and the supper, and a rest for seven days afterwards. Total 8 courses are performed.
Eppikajutsutou: Daily oral administration during Capecitabine therapy
Its dose is 7.5g divided in three times/day, before a meal or inter cibos.

Interventions/Control_2

Capecitabine + Vitamin B6 group
One course of Capecitabine: It is the same as intervention 1.
Vitamin B6: Daily oral administration during Capecitabine therapy
Its dose is 60mg divided in three times/day, after a meal.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

20

years-old

>=

Gender

Male and Female

Key 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

Key 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

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Itaru Endo, MD. PhD.

Organization

Yokohama City University Hospital

Division name

Department of Gastroenterological Surgery

Zip code

Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL

045-787-2800

Email

endoit@med.yokohama-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Mitsuyoshi Ota

Organization

Yokohama City University Medical Center

Division name

Gastroenterological center

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL

Email

m_ota@yokohama-cu.ac.jp

Institute

Yokohama City University Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Yokohama Clinical Oncolgy Group (YCOG)

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院（神奈川県）
横浜市立みなと赤十字病院（神奈川県）

Date of disclosure of the study information

2011

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2011

Year

06

Month

15

Day

Date of IRB

Anticipated trial start date

2011

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

07

Month

01

Day

Last modified on

2016

Year

01

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006973