The Effect of Co-administration of Herbal extracts to Sorafenib (NexavarTM) on the QoL in patients with Hepatocellular carcinoma - pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001354

Enrollment

Registered

2015-01-20

Start date

2015-01-19

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

Others(Coadministration of licensed medicines) : We randomly allocated 16 HCC patients to two groups: combined treatment group(Sorafenib + Bojungikgitang or Yukmijihwangtang and control group(sorafeni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HCC patient who is taking Sorafenib or is planning to take Sorafenib. 2. ECOG performance 0~2 3. Age: 20 years ~ 80 years 4. No disability of cognitive function 5. Who voluntarily decide the participation of the study and sign the consent. 6. The patients who can be possible to follow up during the study periods.

Exclusion criteria

Exclusion criteria: 1. HCC patient who is planning to surgery or other chemotherapy. 2. HCC patient who in needed surgical operation due to GI obstruction. 3. Hypertension whitch is not controlled antihypertensive drug. 4. Serum AST and ALT: above 150 U/mL, serum cratinine: above 3.4 mg/dL 5. Who can not sign the consent. 6. The patients who is inappropriated this study confirmed by researchers. 7. Women who have posive urine hCG.

Design outcomes

Primary

Measure	Time frame
QoL (EORCT QLQ-C30, QLQ-HCC18, KPS) and weight change;survival, adverse events of Sorafenib(diarrhea, weight loss, hand-foot skin reaction, skin eruption)	—

Secondary

Measure	Time frame
Adverse events and overall safety	—

Countries

Korea, Republic of

Contacts

Public ContactChang Hyeong Lee

Daegu Catholic Univercity Medical Center

Outcome results