The Effect of Jin Si Herbal Tea on Cancer-related Fatigue... | NCT05454865

Studies
The Effect of Jin Si Herbal Tea on Cancer-related Fatigue of Gynecological Cancer Patients

NCT05454865

Sponsor

Buddhist Tzu Chi General Hospital

Status

Completed

Last Update Posted

Aug 9, 2024Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Cancer-related Fatigue
Gynecologic Cancer

Interventions

Jin Si Herbal Tea
Placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Jul 7, 2022

First Submission Date that Met QC Criteria

Jul 7, 2022

First Posted Date

Jul 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2024

Last Update Posted Date

Aug 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cancer-related fatigue caused by cancer and treatment reduces patients' compliance with treatment. Fatigue caused by chemotherapy usually has multifaceted symptoms, such as being very tired, feeling weak, desperate for rest, or decreased activity. Cancer-related fatigue is often the main reason why patients are reluctant to continue treatment. Even after finished chemotherapy, most patients still feel fatigued.

Therefore, how to solve the patient's fatigue caused by cancer and treatment is a very important issue, and there is no effective treatment at present. This project plans to use the Jin Si herbal tea developed by our hospital to improve cancer-related fatigue.

Detailed Description

Jin Si Herbal Tea Brief mechanism of action: It contains eight kinds of traditional Chinese medicines, mainly including wormwood, fish needle grass, Ophiopogon japonicas, houttuynia cordata, platycodon, licorice, perilla leaves, and chrysanthemum, which promote lung health including dampness and clean lung heat, diuresis, generate body heat, anti-cold, clean blood, and reduce phlegm.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Jin Si Herbal Tea	Experimental	Jin Si Herbal Tea 1 pack (15 ml) oral use twice daily for two cycles (1 cycle = 3 wks)	Dietary Supplement: Jin Si Herbal Tea
Placebo group	Placebo Comparator	Mimic Tea 1 pack (15ml) oral use twice daily in the first cycle, using Jin Si Herbal Tea in the 2nd cycle	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Jin Si Herbal Tea	Dietary Supplement	Jin Si Herbal Tea 1 pack PO bid for 2 treatment cycles (1 cycle = 3 weeks)	Jin Si Herbal Tea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brief Fatigue Inventory-Taiwanese (BFI-T)	scores 0-90, higher scores mean the worse outcome	2 months
Functional Assessment of Cancer Therapy-General (FACT-G7, Version 4)	scores 0-28, higher scores mean the worse outcome	2 months

Secondary Outcomes

Measure	Description	Time Frame
Laboratory assessment (White Blood Cells count, Differential count)	monitor bone marrow function	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who received chemotherapy
Patients who understand the experimental process

Exclusion Criteria:

Unconscious
Severe disease, not well-controlled patients judged by PI
Pregnancy, breastfeeding, menstruation during screening phase
Weakness, allergy to Herbal tea, frequently felt cold

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
DAH-CHING DING, MD, PhD	Buddhist Tzu Chi Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hualien Tzu Chi Hospital		Hualien City	Please Select	970	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Model Description

Patients with advanced cancer and moderate to severe cancer-related fatigue were randomized to receive either Jin Si Herbal Tea or a placebo (mimic fluid) for the first treatment cycle (three weeks) in a double-blind manner. On the next cycle (three weeks), all patients received open-label treatment with Jin Si Herbal Tea.