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

Primary Purpose

Cancer-related Fatigue, Gynecologic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Jin Si Herbal Tea
Placebo
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer-related Fatigue

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hualien Tzu Chi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Jin Si Herbal Tea

Placebo group

Arm Description

Jin Si Herbal Tea 1 pack (15 ml) oral use twice daily for two cycles (1 cycle = 3 wks)

Mimic Tea 1 pack (15ml) oral use twice daily in the first cycle, using Jin Si Herbal Tea in the 2nd cycle

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Laboratory assessment (White Blood Cells count, Differential count)
monitor bone marrow function

Full Information

First Posted
July 7, 2022
Last Updated
July 11, 2022
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05454865
Brief Title
The Effect of Jin Si Herbal Tea on Cancer-related Fatigue of Gynecological Cancer Patients
Official Title
The Effect of Jin Si Herbal Tea on Cancer-related Fatigue of Gynecological Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Fatigue, Gynecologic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind setting
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jin Si Herbal Tea
Arm Type
Experimental
Arm Description
Jin Si Herbal Tea 1 pack (15 ml) oral use twice daily for two cycles (1 cycle = 3 wks)
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Mimic Tea 1 pack (15ml) oral use twice daily in the first cycle, using Jin Si Herbal Tea in the 2nd cycle
Intervention Type
Dietary Supplement
Intervention Name(s)
Jin Si Herbal Tea
Intervention Description
Jin Si Herbal Tea 1 pack PO bid for 2 treatment cycles (1 cycle = 3 weeks)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo 1 1pack PO bid for 1 treatment cycle (1 cycle = 3 weeks) and followed by Jin Si Herbal Tea 1 pack PO bid for the 2nd treatment cycle
Primary Outcome Measure Information:
Title
Brief Fatigue Inventory-Taiwanese (BFI-T)
Description
scores 0-90, higher scores mean the worse outcome
Time Frame
2 months
Title
Functional Assessment of Cancer Therapy-General (FACT-G7, Version 4)
Description
scores 0-28, higher scores mean the worse outcome
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Laboratory assessment (White Blood Cells count, Differential count)
Description
monitor bone marrow function
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DAH-CHING DING, MD, PhD
Phone
88638561825
Ext
13383
Email
dah1003@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DAH-CHING DING, MD, PhD
Organizational Affiliation
Buddhist Tzu Chi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hualien Tzu Chi Hospital
City
Hualien City
State/Province
Please Select
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DAH-CHING DING, MD, PhD
Phone
88638561825
Ext
13383
Email
dah1003@yahoo.com.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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