Cancer Patients Undergoing Chemotherapy or RadiotherapyNCT01580358
Therapeutic Effects of Traditional Chinese Medicine, Shen-Mai San in Cancer Patient Undergoing Chemotherapy or Radiotherapy
A study testing Shen-Mai San and Starch in people with Cancer Patients Undergoing Chemotherapy or Radiotherapy, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help these people improve the quality of life. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer Patients Undergoing Chemotherapy or Radiotherapy
- What is being tested?
- Shen-Mai San and Starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2009to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Changhua Christian Hospital
Changhua
Chia Yun Chen, MD, +886-47238595 ext. 4027, 137877@cch.org.tw
Lun Chien Lo, MD.PhD
About this study
Official title: Changhua Christian Hospital
Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help these people improve the quality of life.
Read the detailed description
Shen-Mai-San could improve fatigue, general weakness, neutropenia for patients under going chemotherapy or radiotherapy.
- Being tested
- Shen-Mai San, Starch
- Keywords
- cancer, radiotherapy, chemotherapy, Traditional Chinese Medicine, Safety
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
StarchDrug
It was packed in granules with 0.5gm starch. Patients took eight granules three times per day for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Shen-Mai San |
| starch | Placebo comparator | Starch in the same granule as intervention group for this double-blind trial Receives: Drug: Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in EORTC QOL-C30 at four weeks
Measured: baseline and four weeks
Secondary outcomes (2)
Change from baseline in BUN, Creatinine, GOT, GPT at four weeks
monitor the liver function and renal function
Measured: baseline and four weeks
Change from baseline in Heart rate variability at four weeks
Measured: baseline and four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startOct 2009
- Primary completionJun 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer Patients Undergoing Chemotherapy or RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Committee on Chinese Medicine and Pharmacy
- Responsible party
- Principal investigator, Chia-Yun Chen, Changhua Christian Hospital
- Investigators
- Lun Chien Lo, MD. PhD, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580358
- Sponsor's protocol ID
- CCMP98 -CT-203
- Status last verified
- Jun 2012
- First submitted
- 16 Apr 2012
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23206440
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changhua Christian Hospital
- ClinicalTrials.gov ID
- NCT01580358
- Acronym / sponsor ID
- CCMP98 -CT-203
- Keywords
- cancer, radiotherapy, chemotherapy, Traditional Chinese Medicine, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Collaborators
- Committee on Chinese Medicine and Pharmacy
- Study start
- Oct 2009
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shen-Mai San | Active comparator | Drug: Shen-Mai SanShen 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 | Placebo comparator | Drug: StarchStarch in the same granule as intervention group for this double-blind trial |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shen-Mai SanShen 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 |
| StarchIt was packed in granules with 0.5gm starch. Patients took eight granules three times per day for four weeks. | Drug | starch |
Primary outcome
Change from baseline in EORTC QOL-C30 at four weeks
Time frame: baseline and four weeks
2 secondary outcomes
Change from baseline in BUN, Creatinine, GOT, GPT at four weeks
Time frame: baseline and four weeks
Change from baseline in Heart rate variability at four weeks
Time frame: baseline and four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
- Derived from this study: PubMed 23206440Lo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lun Chien Lo, MD. PhD principal investigator
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shen-Mai San and Starch in people with Cancer Patients Undergoing Chemotherapy or Radiotherapy, run by Changhua Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia Yun Chen, MD (+886-47238595 ext. 4027, 137877@cch.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in EORTC QOL-C30 at four weeks (time frame: baseline and four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01580358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.