The effect of co-administration of Samryungbaekchulsan to 5 FU + eloxatin on the chemotherapy induced gut toxicity and immune function in colon cancer patient - pilot study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001348

Enrollment

Registered

2015-01-19

Start date

2014-12-19

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : Patients with colorectal cancer were randomized to receive either Samryungbaekchulsan or placebo in addition to standard chemotherapy. The study group received Chinese herbal medicine three ti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. proven colorectal cancer patient 2. age between 18 - 75 yrs 3. Patients who receive FOLFOX(Oxaliplatin/LV5FU2) chemotherapy including Oxaliplatin 4 less than Eastern Cooperative Oncology Group (ECOG) performance status 2 5. patient who is possible to follow up

Exclusion criteria

Exclusion criteria: 1. current metastatic colorectal cancer 2. patients who need surgery including intestinal obstruction 3. prenant, breastfeeding woman 4. patients who have psychological diseases or problems 5. patients who do not agree with the trial 6. moderate to severe hepatotoxicity or renal toxicity(AST, ALT > 100 IU/L, Creatinine >3.4mg/dl) 7. allergic or hyper-reactive response to Samryungbaekchulsan

Design outcomes

Primary

Measure	Time frame
Gut toxicity in CTCAE(Common Terminology Criteria for Adverse Effect) grading system	—

Secondary

Measure	Time frame
immunologic function including WBC(White Blood Cell) count, CRP(C-Reactive Protein), T-cell, immunoglobulin G,A,M, NK(Natural Killer) cell, complement	—

Countries

Korea, Republic of

Contacts

Public ContactDae Dong Kim

Daegu Catholic Univercity Medical Center

Outcome results