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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Changhua Christian Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Committee on Chinese Medicine and Pharmacy
Information provided by (Responsible Party):
Chia-Yun Chen, Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT01580358
First received: April 16, 2012
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention
Cancer Patients Undergoing Chemotherapy or Radiotherapy
Drug: Shen-Mai San
Drug: Starch

Study Type: Interventional
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
Official Title: Changhua Christian Hospital

Resource links provided by NLM:


Further study details as provided by Changhua Christian Hospital:

Primary Outcome Measures:
  • Change from baseline in EORTC QOL-C30 at four weeks [ Time Frame: baseline and four weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in BUN, Creatinine, GOT, GPT at four weeks [ Time Frame: baseline and four weeks ] [ Designated as safety issue: Yes ]
    monitor the liver function and renal function

  • Change from baseline in Heart rate variability at four weeks [ Time Frame: baseline and four weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
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).
Placebo Comparator: starch
Starch in the same granule as intervention group for this double-blind trial
Drug: Starch
It was packed in granules with 0.5gm starch. Patients took eight granules three times per day for four weeks.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580358

Contacts
Contact: Chia Yun Chen, MD +886-47238595 ext 4027 137877@cch.org.tw

Locations
Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan
Contact: Chia Yun Chen, MD    +886-47238595 ext 4027    137877@cch.org.tw   
Principal Investigator: Lun Chien Lo, MD.PhD         
Sponsors and Collaborators
Changhua Christian Hospital
Committee on Chinese Medicine and Pharmacy
Investigators
Principal Investigator: Lun Chien Lo, MD. PhD Changhua Christian Hospital
  More Information

No publications provided by Changhua Christian Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chia-Yun Chen, MD, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01580358     History of Changes
Other Study ID Numbers: CCMP98 -CT-203
Study First Received: April 16, 2012
Last Updated: June 19, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Changhua Christian Hospital:
cancer
radiotherapy
chemotherapy
Traditional Chinese Medicine
Safety

ClinicalTrials.gov processed this record on October 22, 2014