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

NCT05454865 | Completed DMC

• 1 other identifier: IRB110-253-A
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer-related Fatigue; Gynecologic Cancer

Outcome Measures

Primary Outcomes (2)

• Brief Fatigue Inventory-Taiwanese (BFI-T)

  scores 0-90, higher scores mean the worse outcome

  2 months

• Functional Assessment of Cancer Therapy-General (FACT-G7, Version 4)

  scores 0-28, higher scores mean the worse outcome

  2 months

Secondary Outcomes (1)

• Laboratory assessment (White Blood Cells count, Differential count)

  2 months

Study Arms (2)

Jin Si Herbal Tea

EXPERIMENTAL

Jin Si Herbal Tea 1 pack (15 ml) oral use twice daily for two cycles (1 cycle = 3 wks)

Dietary Supplement: Jin Si Herbal Tea

Placebo group

PLACEBO COMPARATOR

Mimic Tea 1 pack (15ml) oral use twice daily in the first cycle, using Jin Si Herbal Tea in the 2nd cycle

Dietary Supplement: Placebo

Interventions

Jin Si Herbal Tea DIETARY_SUPPLEMENT

Jin Si Herbal Tea 1 pack PO bid for 2 treatment cycles (1 cycle = 3 weeks)

Jin Si Herbal Tea

Placebo DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who received chemotherapy
• Patients who understand the experimental process

You may not qualify if:

• Unconscious
• Severe disease, not well-controlled patients judged by PI
• Pregnancy, breastfeeding, menstruation during screening phase
• Weakness, allergy to Herbal tea, frequently felt cold

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, Please Select, 970, Taiwan

Location

Study Officials

• DAH-CHING DING, MD, PhD

  Buddhist Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind setting
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)