## Protocol Section
### Identification Module
**NCT ID:** NCT01142479

**Brief Title:** Compound Herbal Formula (TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy

**Official Title:** The Effects of Compound Herbal Formula(TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy

#### Organization Study ID Info
**ID:** TPE-1-breast Ca
#### Organization
**Class:** OTHER_GOV
**Full Name:** Taipei City Hospital
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-05-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-05-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-04

**Type:** ACTUAL

#### Start Date
**Date:** 2010-05

**Status Verified Date:** 2014-05

#### Study First Post Date
**Date:** 2010-06-11
**Type:** ESTIMATED
**Study First Submit Date:** 2010-06-10
**Study First Submit QC Date:** 2010-06-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Taipei Medical University Shuang Ho Hospital

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Taipei City Hospital

#### Responsible Party

**Investigator Affiliation:** Taipei City Hospital

**Investigator Full Name:** Chung-Hua Hsu

**Investigator Title:** vice superintendent

**Type:** PRINCIPAL_INVESTIGATOR

### Description Module

**Brief Summary:** Many breast cancer patients will taking Chinese herbal medicine during receiving radiotherapy. The investigators conducted the pilot study showing Compound Herbal Formula (TPE-1) have the effect of improving the fatigue and leukopenia during radiotherapy. So the investigators designed this double blind and controlled trial to evaluate whether TPE-1 have the effects for leukopenia and cancer-related fatigue in breast cancer patients with radiotherapy. From our initial observation for 2 years, TPE-1 is safety. The study is also designed to evaluate the safety when patients taking this formula.

**Detailed Description:** TPE-1 is designed according to TCM concept. It is not anti-cancer directly, it is enhancing the Qi flow and immunity of breast cancer when they are just finishing chemotherapy and on going radiotherapy. Many Chinese population will seeking Chinese herbal medicine under the same condition.

### Conditions Module

**Conditions:**

- Breast Cancer

- Radiotherapy

- Chinese Herbal Medicine

**Keywords:**

- Breast Cancer

- Radiotherapy

- Chinese herbal medicine

- TPE-1

- Leukopenia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** dilute of (TPE-1) decoction.

**Intervention Names:**

- Drug: Chinese herbal medicine decoction

**Label:** herbal A

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** TPE-1 decoction (100 ml)

**Intervention Names:**

- Drug: Chinese herbal medicine decoction

**Label:** herbal B

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- herbal A

- herbal B

**Description:** 100 ml /Qd for 6 weeks(42 days)

**Name:** Chinese herbal medicine decoction

**Other Names:**

- TPE-1

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** WBC will be checked before taking TPE ans after taking TPE-1.

**Measure:** the % change of white blood cell(WBC) count

**Time Frame:** 6 weeks

#### Secondary Outcomes

**Description:** The Hb will be checked before and after kaking TPE-1

**Measure:** Hemoglobin (Hb)

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* breast cancer
* age between 18 to 70 yrs
* finished chemotherapy (adriamycin ), will receiving radiotherapy
* Chinese population
* KP$ between 40-100
* ECOG \< 2
* WBC \>4X10(9)／L and Hb \> 10g/dl
* Assigned informed concent.

Exclusion Criteria:

* receiving operation during 14 days
* blood transfusion during one month.
* ALT \>100mg/dL
* Creatinine \>2.0mg/dL
* Total bilirubin \>2.0mg/dL
* Infection
* prolation
* Taking anti-seizure , psychological drugs or any drugs not suitable patients
* AIDS or any disease diagnosed by physician and not suitable patients.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taipei

**Country:** Taiwan

**Facility:** Shuang Ho Hospital

**Zip:** 886

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000095542

- Term: Cytopenia

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000007960

- Term: Leukocyte Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC15

- Name: Blood and Lymph Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M8364

- Name: Fatigue

- Relevance: LOW

- As Found: Unknown

- ID: M10973

- Name: Leukopenia

- Relevance: HIGH

- As Found: Leukopenia

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3170

- Name: Cytopenia

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10963

- Name: Leukocyte Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000007970

- Term: Leukopenia

### Misc Info Module

- Version Holder: 2024-05-24
