Breast CancerPhase 2/3NCT01142479
Compound Herbal Formula (TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
A Phase 2/3 study testing Chinese herbal medicine decoction in people with Breast Cancer and Radiotherapy, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
Many breast cancer patients will taking Chinese herbal medicine during receiving radiotherapy. The investigators conducted the pilot study showing Compound Herbal Formula (TPE-1) have the effect of improving the fatigue and leukopenia during radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Radiotherapy, Chinese Herbal Medicine
- What is being tested?
- Chinese herbal medicine decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2010to Apr 2011
- Phase
- Phase 2/3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer
- age between 18 to 70 yrs
- finished chemotherapy (adriamycin ), will receiving radiotherapy
- Chinese population
- KP$ between 40-100
- ECOG < 2
- WBC >4X10(9)／L and Hb > 10g/dl
- Assigned informed concent.
Who cannot join
- receiving operation during 14 days
- blood transfusion during one month.
- ALT >100mg/dL
- Creatinine >2.0mg/dL
- Total bilirubin >2.0mg/dL
- Infection
Show all 9Show fewer
- prolation
- Taking anti-seizure , psychological drugs or any drugs not suitable patients
- AIDS or any disease diagnosed by physician and not suitable patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Compound Herbal Formula(TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
Many breast cancer patients will taking Chinese herbal medicine during receiving radiotherapy. The investigators conducted the pilot study showing Compound Herbal Formula (TPE-1) have the effect of improving the fatigue and leukopenia during radiotherapy. So the investigators designed this double blind and controlled trial to evaluate whether TPE-1 have the effects for leukopenia and cancer-related fatigue in breast cancer patients with radiotherapy. From our initial observation for 2 years, TPE-1 is safety. The study is also designed to evaluate the safety when patients taking this formula.
Read the detailed description
TPE-1 is designed according to TCM concept. It is not anti-cancer directly, it is enhancing the Qi flow and immunity of breast cancer when they are just finishing chemotherapy and on going radiotherapy. Many Chinese population will seeking Chinese herbal medicine under the same condition.
- Conditions
- Breast Cancer, Radiotherapy, Chinese Herbal Medicine
- Being tested
- Chinese herbal medicine decoction
- Keywords
- Breast Cancer, Radiotherapy, Chinese herbal medicine, TPE-1, Leukopenia
- Medical subject headings
- Breast Neoplasms, Leukopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal medicine decoctionDrug
Also called TPE-1
100 ml /Qd for 6 weeks(42 days)
| Study group | Role | What they receive |
|---|---|---|
| herbal A | Placebo comparator | dilute of (TPE-1) decoction. Receives: Drug: Chinese herbal medicine decoction |
| herbal B | Experimental | TPE-1 decoction (100 ml) Receives: Drug: Chinese herbal medicine decoction |
What is being measured
The primary outcome is the main question the study is designed to answer.
the % change of white blood cell(WBC) count
WBC will be checked before taking TPE ans after taking TPE-1.
Measured: 6 weeks
Secondary outcomes (1)
Hemoglobin (Hb)
The Hb will be checked before and after kaking TPE-1
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Collaborators
- Taipei Medical University Shuang Ho Hospital
- Responsible party
- Principal investigator, Chung-Hua Hsu, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142479
- Sponsor's protocol ID
- TPE-1-breast Ca
- Status last verified
- May 2014
- First submitted
- 10 Jun 2010
- Last updated
- 29 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Compound Herbal Formula(TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
- ClinicalTrials.gov ID
- NCT01142479
- Acronym / sponsor ID
- TPE-1-breast Ca
- Conditions
- Breast Cancer, Radiotherapy, Chinese Herbal Medicine
- Keywords
- Breast Cancer, Radiotherapy, Chinese herbal medicine, TPE-1, Leukopenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Collaborators
- Taipei Medical University Shuang Ho Hospital
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- First posted
- 11 Jun 2010 (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.
Many breast cancer patients will taking Chinese herbal medicine during receiving radiotherapy. The investigators conducted the pilot study showing Compound Herbal Formula (TPE-1) have the effect of improving the fatigue and leukopenia during radiotherapy. So the investigators designed this double blind and controlled trial to evaluate whether TPE-1 have the effects for leukopenia and cancer-related fatigue in breast cancer patients with radiotherapy. From our initial observation for 2 years, TPE-1 is safety. The study is also designed to evaluate the safety when patients taking this formula.
Detailed description
TPE-1 is designed according to TCM concept. It is not anti-cancer directly, it is enhancing the Qi flow and immunity of breast cancer when they are just finishing chemotherapy and on going radiotherapy. Many Chinese population will seeking Chinese herbal medicine under the same condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| herbal A | Placebo comparator | Drug: Chinese herbal medicine decoctiondilute of (TPE-1) decoction. |
| herbal B | Experimental | Drug: Chinese herbal medicine decoctionTPE-1 decoction (100 ml) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- breast cancer
- age between 18 to 70 yrs
- finished chemotherapy (adriamycin ), will receiving radiotherapy
- Chinese population
- KP$ between 40-100
Key exclusion criteria (9 listed)
- receiving operation during 14 days
- blood transfusion during one month.
- ALT >100mg/dL
- Creatinine >2.0mg/dL
- Total bilirubin >2.0mg/dL
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 |
|---|---|---|
| Chinese herbal medicine decoctionAlso: TPE-1100 ml /Qd for 6 weeks(42 days) | Drug | herbal A, herbal B |
Primary outcome
the % change of white blood cell(WBC) count
Time frame: 6 weeks
WBC will be checked before taking TPE ans after taking TPE-1.
1 secondary outcome
Hemoglobin (Hb)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Chinese herbal medicine decoction in people with Breast Cancer and Radiotherapy, run by Taipei City 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 29 May 2014. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the % change of white blood cell(WBC) count (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2014.