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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04606121
Other study ID # TCHIRB-10905008-E
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 11, 2020
Est. completion date June 11, 2020

Study information

Verified date July 2020
Source Taipei City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 401
Est. completion date June 11, 2020
Est. primary completion date June 11, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
enhanced day care of TCM include acupuncture, massage, tai ji quan, TCM herbal medicine
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

Locations

Country Name City State
Taiwan Taipei city hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2020
Secondary scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T) evaluate the level of fatique 2020
Secondary scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF) evaluate QOL 2020
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