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

Cancer Patients Undergoing Chemotherapy or Radiotherapy Clinical Trial

Official title:

Changhua Christian Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01580358
• Other study ID #: CCMP98 -CT-203
• Status: Recruiting
• Phase: N/A
• First received: April 16, 2012
• Last updated: June 19, 2012
• Start date: October 2009
• Est. completion date: September 2012

Study information

• Verified date: June 2012
• Source: Changhua Christian Hospital
• Contact: Chia Yun Chen, MD
• Phone: +886-47238595
• Email: 137877[@]cch.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer Patients Undergoing Chemotherapy or Radiotherapy

Intervention

Drug:
• 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
It was packed in granules with 0.5gm starch. Patients took eight granules three times per day for four weeks.

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua

Sponsors (2)

Lead Sponsor	Collaborator
Changhua Christian Hospital	Committee on Chinese Medicine and Pharmacy

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in EORTC QOL-C30 at four weeks		baseline and four weeks	No
Secondary	Change from baseline in BUN, Creatinine, GOT, GPT at four weeks	monitor the liver function and renal function	baseline and four weeks	Yes
Secondary	Change from baseline in Heart rate variability at four weeks		baseline and four weeks	No