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

Taipei City Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Breast Cancer; Chinese Herbal Medicine; Radiotherapy

Treatments: Drug: Chinese herbal medicine decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT01142479

TPE-1-breast Ca

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

herbal A

Placebo Comparator group

Description:

dilute of (TPE-1) decoction.

Treatment:

Drug: Chinese herbal medicine decoction

herbal B

Experimental group

Description:

TPE-1 decoction (100 ml)

Treatment:

Drug: Chinese herbal medicine decoction