Therapeutic Effects of Traditional Chinese Medicine, Shen-Mai San in Cancer Patient Undergoing Chemotherapy or Radiotherapy

Study Overview
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Brief Summary
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Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help these people improve the quality of life.

Detailed Description
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Shen-Mai-San could improve fatigue, general weakness, neutropenia for patients under going chemotherapy or radiotherapy.

Official Title
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Changhua Christian Hospital

Conditions
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Cancer Patients Undergoing Chemotherapy or Radiotherapy

Intervention / Treatment
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* Drug: Shen-Mai San
* Drug: Starch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postoperative patients with histologically confirmed cancer within 3 years and undergoing chemotherapy or radiotherapy age above 18 years old signed informed consent ability to read Chinese, ability for oral intake. Exclusion Criteria: being pregnancy on breast feeding completed chemotherapy or radiotherapy brain metastasis with Eastern Cooperative Oncology Group (ECOG) performance status of two to four delusion or hallucination acute infection received medications for other clinical trials.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Shen-Mai San<br>Shen mai san is composed of three herb medicines, Ginseng radis, Liriope spicata, and Schizandrae fructus and was manufactured into concentrated herbal extract and packed with 0.5g per capsule and labeled by Sun-Ten pharmaceutical company in Taiwan with good manufacturing practice (GMP). | Drug: Shen-Mai San<br>* Shen mai san is composed of three herb medicines, Ginseng radis, Liriope spicata, and Schizandrae fructus and was manufactured into concentrated herbal extract and packed with 0.5g per capsule and labeled by Sun-Ten pharmaceutical company in Taiwan with good manufacturing practice (GMP).<br>|
| Placebo Comparator: starch<br>Starch in the same granule as intervention group for this double-blind trial | Drug: Starch<br>* It was packed in granules with 0.5gm starch. Patients took eight granules three times per day for four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in EORTC QOL-C30 at four weeks |  | baseline and four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in BUN, Creatinine, GOT, GPT at four weeks | monitor the liver function and renal function | baseline and four weeks | 
| Change from baseline in Heart rate variability at four weeks |  | baseline and four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, radiotherapy, chemotherapy, Traditional Chinese Medicine, Safety