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

Not Applicable

• Conditions: Cancer Patients Undergoing Chemotherapy or Radiotherapy
• Interventions: Drug: Shen-Mai San; Drug: Starch

• Registration Number: NCT01580358
• Lead Sponsor: Changhua Christian Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-19
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-21
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shen-Mai San	Shen-Mai San	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).
starch	Starch	Starch in the same granule as intervention group for this double-blind trial

Primary Outcome Measures

Name	Time	Method
Change from baseline in EORTC QOL-C30 at four weeks	baseline and four weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in BUN, Creatinine, GOT, GPT at four weeks	baseline and four weeks	monitor the liver function and renal function
Change from baseline in Heart rate variability at four weeks	baseline and four weeks

Trial Locations

Locations (1)

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan