Clinical trial NCT05454865: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Fatigue
Gynecologic Cancer
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 21
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Brief Fatigue Inventory-Taiwanese (BFI-T)
timeFrame: 2 months
measure: Functional Assessment of Cancer Therapy-General (FACT-G7, Version 4)
timeFrame: 2 months
Secondary outcomes:
measure: Laboratory assessment (White Blood Cells count, Differential count)
timeFrame: 2 months
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
state: Please Select
Study officials:
affiliation: Buddhist Tzu Chi Hospital
name: DAH-CHING DING, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: