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

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05454865
• Other study ID #: IRB110-253-A
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2021
• Source: Buddhist Tzu Chi General Hospital
• Contact: DAH-CHING DING, MD, PhD
• Phone: 88638561825
• Email: dah1003[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue
• Gynecologic Cancer

Intervention

Dietary Supplement:
• Jin Si Herbal Tea
Jin Si Herbal Tea 1 pack PO bid for 2 treatment cycles (1 cycle = 3 weeks)
• Placebo
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

Locations

Country	Name	City	State
Taiwan	Hualien Tzu Chi Hospital	Hualien City	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Fatigue Inventory-Taiwanese (BFI-T)	scores 0-90, higher scores mean the worse outcome	2 months
Primary	Functional Assessment of Cancer Therapy-General (FACT-G7, Version 4)	scores 0-28, higher scores mean the worse outcome	2 months
Secondary	Laboratory assessment (White Blood Cells count, Differential count)	monitor bone marrow function	2 months