Cancer-related Fatigue, Gynecologic Cancer
Conditions
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.
Interventions
DIETARY_SUPPLEMENTJin Si Herbal Tea
Jin Si Herbal Tea 1 pack PO bid for 2 treatment cycles (1 cycle = 3 weeks)
DIETARY_SUPPLEMENTPlacebo
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
Sponsors
Buddhist Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-blind setting
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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Fatigue Inventory-Taiwanese (BFI-T) | 2 months | scores 0-90, higher scores mean the worse outcome |
| Functional Assessment of Cancer Therapy-General (FACT-G7, Version 4) | 2 months | scores 0-28, higher scores mean the worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory assessment (White Blood Cells count, Differential count) | 2 months | monitor bone marrow function |
Countries
Taiwan
Outcome results
None listed