NCT01580358

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2012

Enrollment Period

2.7 years

First QC Date

April 16, 2012

Last Update Submit

June 19, 2012

Conditions

Cancer Patients Undergoing Chemotherapy or Radiotherapy

Keywords

cancerradiotherapychemotherapyTraditional Chinese MedicineSafety

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in EORTC QOL-C30 at four weeks

    baseline and four weeks

Secondary Outcomes (2)

  • Change from baseline in BUN, Creatinine, GOT, GPT at four weeks

    baseline and four weeks

  • Change from baseline in Heart rate variability at four weeks

    baseline and four weeks

Study Arms (2)

Shen-Mai San

ACTIVE COMPARATOR

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

starch

PLACEBO COMPARATOR

Starch in the same granule as intervention group for this double-blind trial

Drug: Starch

Interventions

Shen-Mai SanDRUG

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).

Shen-Mai San
StarchDRUG

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

starch

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhua Christian Hospital

Changhua, Taiwan

RECRUITING

Related Publications (1)

  • Lo LC, Chen CY, Chen ST, Chen HC, Lee TC, Chang CS. Therapeutic efficacy of traditional Chinese medicine, Shen-Mai San, in cancer patients undergoing chemotherapy or radiotherapy: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2012 Dec 3;13:232. doi: 10.1186/1745-6215-13-232.

    PMID: 23206440DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Starch

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Lun Chien Lo, MD. PhD

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia Yun Chen, MD

CONTACT

+886-47238595137877@cch.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 19, 2012

Study Start

October 1, 2009

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

June 21, 2012

Record last verified: 2012-06

Locations

TW(1)