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
About this trial
This is an interventional treatment trial for Cancer-related Fatigue
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
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
NCT ID
NCT05454865
First Posted
July 7, 2022
Last Updated
July 11, 2022
Sponsor
Buddhist Tzu Chi General Hospital
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
We'll reach out to this number within 24 hrs