MyelosuppressionNCT05442177
Clinical Observation of Integrated Chinese Medicine With Western Medicine for the Reduction of Chemotherapy-induced Hematologic Toxicity
An observational study of Myelosuppression, run by Taichung Tzu Chi Hospital.
Trial summary
We conducted an observational study to investigate the effectiveness and safety of Integrated Chinese Medicine With Western Medicine for bone marrow suppression induced by chemotherapy in patients with cancer. The TCM constitution and pulse diagnosis was also observed in the study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myelosuppression
- What is being tested?
- Chemotherapy and Integrated Chinese Medicine With Western Medicine for cancer treatment
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 30 Jun 2016
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients with cancer under chemotherapy and Integrated Chinese Medicine With Western Medicine.
Who may be able to join
- Patients with cancer diagnosed through pathological histology
- Patients with cancer under chemotherapy and Integrated Chinese Medicine With Western Medicine
- Patients with an Eastern Cooperative Oncology Group Performance score of 0-2
- Patients having normal liver and kidney functions and electrocardiography and eligible for chemotherapy with normal bone marrow hematopoietic function
- Patients who were voluntarily involved in this study
Who cannot join
- Cases that did not meet the inclusion criteria
- Patients who could not cooperate with pulse diagnosis
- Patients with underlying diseases such as chronic obstructive pulmonary disease, cardiac failure, chronic renal failure, cirrhosis, etc.
- Patients with severe infection
- Patients with severe cachexia
About this study
We conducted an observational study to investigate the effectiveness and safety of Integrated Chinese Medicine With Western Medicine for bone marrow suppression induced by chemotherapy in patients with cancer. The TCM constitution and pulse diagnosis was also observed in the study.
Read the detailed description
Patients with cancer under chemotherapy and integrated Western and Chinese medicine were enrolled in this observational study. The assessment of radial pressure pulse (RPP) was performed before and after chemotherapy. The correlation between the spectral energy (SE0-10 Hz, SE10-50 Hz, and SE13-50 Hz) of the RPP at six diagnosis positions and the blood cell counts before and after chemotherapy were analyzed.
- Conditions
- Myelosuppression
- Being tested
- Chemotherapy and Integrated Chinese Medicine With Western Medicine for cancer treatment
- Keywords
- Traditional Chinese Medicine; radial pulse assessment; sphygmography; pulse diagnosis; myelosuppression; cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy and Integrated Chinese Medicine With Western Medicine for cancer treatmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy-induced Hematologic Toxicity
the blood cell count before and after chemotherapy was collected for measurement of severity of myelosuppression
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Jul 2015
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelosuppressionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Tzu Chi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Ying Chuang, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442177
- Sponsor's protocol ID
- REC104-12
- Status last verified
- Jun 2022
- First submitted
- 28 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Integrated Chinese Medicine With Western Medicine for the Reduction of Chemotherapy-induced Hematologic Toxicity
- ClinicalTrials.gov ID
- NCT05442177
- Acronym / sponsor ID
- REC104-12
- Conditions
- Myelosuppression
- Keywords
- Traditional Chinese Medicine; radial pulse assessment; sphygmography; pulse diagnosis; myelosuppression; cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Taichung Tzu Chi HospitalUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 1 Jul 2022 (actual)
- 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.
We conducted an observational study to investigate the effectiveness and safety of Integrated Chinese Medicine With Western Medicine for bone marrow suppression induced by chemotherapy in patients with cancer. The TCM constitution and pulse diagnosis was also observed in the study.
Detailed description
Patients with cancer under chemotherapy and integrated Western and Chinese medicine were enrolled in this observational study. The assessment of radial pressure pulse (RPP) was performed before and after chemotherapy. The correlation between the spectral energy (SE0-10 Hz, SE10-50 Hz, and SE13-50 Hz) of the RPP at six diagnosis positions and the blood cell counts before and after chemotherapy were analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer under chemotherapy and Integrated Chinese Medicine With Western Medicine.
Key inclusion criteria (5 listed)
- Patients with cancer diagnosed through pathological histology
- Patients with cancer under chemotherapy and Integrated Chinese Medicine With Western Medicine
- Patients with an Eastern Cooperative Oncology Group Performance score of 0-2
- Patients having normal liver and kidney functions and electrocardiography and eligible for chemotherapy with normal bone marrow hematopoietic function
- Patients who were voluntarily involved in this study
Key exclusion criteria (5 listed)
- Cases that did not meet the inclusion criteria
- Patients who could not cooperate with pulse diagnosis
- Patients with underlying diseases such as chronic obstructive pulmonary disease, cardiac failure, chronic renal failure, cirrhosis, etc.
- Patients with severe infection
- Patients with severe cachexia
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 |
|---|---|---|
| Chemotherapy and Integrated Chinese Medicine With Western Medicine for cancer treatment | Procedure or surgery | – |
Primary outcome
Chemotherapy-induced Hematologic Toxicity
Time frame: one month
the blood cell count before and after chemotherapy was collected for measurement of severity of myelosuppression
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 1 Jul 2022.
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Tumor Patients
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelosuppression, run by Taichung Tzu Chi Hospital.
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 5 inclusion and 5 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 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
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?
Chemotherapy-induced Hematologic Toxicity (time frame: one month). 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 1 Jul 2022.