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

Not Applicable

Completed

• Conditions: Cancer-related Fatigue; Gynecologic Cancer
• Interventions: Dietary Supplement: Jin Si Herbal Tea; Dietary Supplement: Placebo

• Registration Number: NCT05454865
• Lead Sponsor: Buddhist Tzu Chi General Hospital

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Jin Si Herbal Tea	Jin Si Herbal Tea	Jin Si Herbal Tea 1 pack (15 ml) oral use twice daily for two cycles (1 cycle = 3 wks)
Placebo group	Placebo	Mimic Tea 1 pack (15ml) oral use twice daily in the first cycle, using Jin Si Herbal Tea in the 2nd cycle

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Laboratory assessment (White Blood Cells count, Differential count)	2 months	monitor bone marrow function

Trial Locations

Locations (1)

Hualien Tzu Chi Hospital; 🇨🇳 Hualien City, Please Select, Taiwan