Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients

Kyung Hee University

Status: Unknown

Conditions: Breast Carcinoma

Treatments: Drug: Sipjeondaebo-tang

Study type: Interventional

Funder types: Other

Identifiers

NCT02858856

ISEE_2016_SJDBT

Details and patient eligibility

About

This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• men and women aged over 18 years
• patients who have histologically or cytologically confirmed breast tumor
• patients who applicable AC(doxorubicin + cyclophosphamide)
• ECOG score 0 to 2

Exclusion criteria

• patient impossible to orally intake
• patient with dementia, delirium and depression
• patient suffering from diseases like chronic hepatitis B, C or hepatocirrhosis
• severe liver disability (3-fold the normal high range value for ALT, AST)
• patient who has diabetes not controlled by diet, hypertension, hyperthyroidism,
• severe systemic disease
• use of other investigational products within the past 30 days
• hypersensitivity to investigational product
• others who are judged not to be appropriate to study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

A group

Experimental group

Description:

Take Sipjeondaebo-tang on 0\~2 week, 3\~5 week of clinical trial period, total of 4 weeks

Treatment:

Drug: Sipjeondaebo-tang

B group

Experimental group

Description:

Take Sipjeondaebo-tang on 6\~8 week, 9\~11 week of clinical trial period, total of 4 weeks

Treatment:

Drug: Sipjeondaebo-tang