Chemotherapy-Induced ChangeNCT04606121
The Benefit of Enhanced Day Care of Traditional Chinese Medicine: A Retrospective Study of Medical Records
An observational study of Chemotherapy-Induced Change, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
We collected medical records since June 2017 to November 2019., used pair-T test for questionnaire of CTCAE, BFT-I, WHOQOL to evaluate the benefit of enhanced day care of TCM for cancer patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chemotherapy-Induced Change
- What is being tested?
- enhanced day care of TCM include acupuncture, massage, tai ji quan, TCM herbal medicine
- How many people
- 401 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jun 2020to 11 Jun 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cancer patients who needed to accept surgery, or chemotherapy, or radiotherapy, or other conventional cancer therapy
Who may be able to join
- The medical records since June 2017 to December 2019 needed to meet the following criterial: (1)age>20 years old, (2)diagnosis meet ICD10:C00.0-C97 (3) needed to do Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE), scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T) and scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF), and those scales needed to be done pretest when patient came to the clinics and posttest when case end.
Who cannot join
- The subjects will be excluded if they do not complete pretest and posttest of the following scales:(1) Taiwan brief version scale of CTCAE, (2) BFI-T scale (3) WHOQOL-BREF scale
Trial locations and contacts
1 site in 1 country.
About this study
We collected medical records since June 2017 to November 2019., used pair-T test for questionnaire of CTCAE, BFT-I, WHOQOL to evaluate the benefit of enhanced day care of TCM for cancer patients.
Read the detailed description
using TCM method as Complementary and Alternative Medicine is worldwide. we collected medical records that using TCM methods for adverse event from cancer therapies. we used CTCAE BFI-T and WHOQOF-BREF to evaluate the benefit.
- Conditions
- Chemotherapy-Induced Change
- Being tested
- enhanced day care of TCM include acupuncture, massage, tai ji quan, TCM herbal medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced day care of TCM include acupuncture, massage, tai ji quan, TCM herbal medicineCombination product
acupuncture twice in enhanced day care of TCM massage twice in enhanced day care of TCM tai ji quan one time in enhanced day care of TCM TCM herbal powder three times a day
What is being measured
The primary outcome is the main question the study is designed to answer.
scale of Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE)
for chemotherapy related adverse effects in Taiwan
Measured: 2020
Secondary outcomes (2)
scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T)
evaluate the level of fatique
Measured: 2020
scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF)
evaluate QOL
Measured: 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start11 Jun 2020
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
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 Chemotherapy-Induced ChangeStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606121
- Sponsor's protocol ID
- TCHIRB-10905008-E
- Status last verified
- Jul 2020
- First submitted
- 23 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu HA, Chen CH, Hsieh MH, Wu YC, Chiu JP, Huang CJ, Hsu CH. The Benefit of Enhanced Daycare of Traditional Chinese Medicine for Cancer Treatment Related Adverse Events: A Retrospective Study of Medical Records. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211025634. doi: 10.1177/15347354211025634.
PubMed 34142595
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of Enhanced Day Care of Traditional Chinese Medicine: A Retrospective Study of Medical Records
- ClinicalTrials.gov ID
- NCT04606121
- Acronym / sponsor ID
- TCHIRB-10905008-E
- Conditions
- Chemotherapy-Induced Change
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 28 Oct 2020 (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 collected medical records since June 2017 to November 2019., used pair-T test for questionnaire of CTCAE, BFT-I, WHOQOL to evaluate the benefit of enhanced day care of TCM for cancer patients.
Detailed description
using TCM method as Complementary and Alternative Medicine is worldwide. we collected medical records that using TCM methods for adverse event from cancer therapies. we used CTCAE BFI-T and WHOQOF-BREF to evaluate the benefit.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cancer patients who needed to accept surgery, or chemotherapy, or radiotherapy, or other conventional cancer therapy
Key inclusion criteria (1 listed)
- The medical records since June 2017 to December 2019 needed to meet the following criterial: (1)age>20 years old, (2)diagnosis meet ICD10:C00.0-C97 (3) needed to do Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE), scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T) and scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF), and those scales needed to be done pretest when patient came to the clinics and posttest when case end.
Key exclusion criteria (1 listed)
- The subjects will be excluded if they do not complete pretest and posttest of the following scales:(1) Taiwan brief version scale of CTCAE, (2) BFI-T scale (3) WHOQOL-BREF scale
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 |
|---|---|---|
| enhanced day care of TCM include acupuncture, massage, tai ji quan, TCM herbal medicineacupuncture twice in enhanced day care of TCM massage twice in enhanced day care of TCM tai ji quan one time in enhanced day care of TCM TCM herbal powder three times a day | Combination product | – |
Primary outcome
scale of Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE)
Time frame: 2020
for chemotherapy related adverse effects in Taiwan
2 secondary outcomes
scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T)
Time frame: 2020
scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF)
Time frame: 2020
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 28 Oct 2020.
- Derived from this study: PubMed 34142595Wu HA, Chen CH, Hsieh MH, Wu YC, Chiu JP, Huang CJ, Hsu CH. The Benefit of Enhanced Daycare of Traditional Chinese Medicine for Cancer Treatment Related Adverse Events: A Retrospective Study of Medical Records. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211025634. doi: 10.1177/15347354211025634.
- Individual participant dataSharing planned: No
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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?
An observational study of Chemotherapy-Induced Change, 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 1 inclusion and 1 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 28 Oct 2020. 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. 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?
scale of Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE) (time frame: 2020). 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 NCT04606121, 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 28 Oct 2020.