RSYR for Fatigue Reduction in Cancer Fatigue Caused by Chemotherapy
TCM
A Multicenter, Randomized, Double-blind Clinical Trial of TCM in Reducing CRF Caused by Chemotherapy in Cancer Patients
2 other identifiers
interventional
196
1 country
1
Brief Summary
This is a multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of Chinese herbal compound in improving fatigue symptoms and quality of life in patients with chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2020
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2020
CompletedFirst Submitted
Initial submission to the registry
December 3, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJanuary 19, 2024
January 1, 2024
3.4 years
December 3, 2021
January 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue score
Self-assessed 24-hour fatigue symptom score. According to the NCCN fatigue guide, the score is 0-10 points, 0 points means no fatigue, 10 points means the most serious fatigue that can be imagined.
21 days
Study Arms (2)
TCM decoction
EXPERIMENTALCompound granules of Traditional Chinese Medicine
placebo
PLACEBO COMPARATORPlacebo only
Interventions
TCM herbs：White peony 10g, angelica 10g, Astragalus 20g, Atractylodes macrocephala 10g, tangerine peel 6g, Poria cocos 10g, raw land 10g, cinnamon 3g, Polygala tenuifolia 6g, Schisandra chinensis 6g, raw licorice 6g.
Mainly made of dextrin and caramel, containing 1/30 concentration of experimental group drugs
Eligibility Criteria
You may qualify if:
- Malignant tumor patients with pathological diagnosis
- Men and women aged 18-75
- KPS score ≥ 70, expected survival time more than 6 months
- The function of heart, lung, liver and kidney was normal
- Hemoglobin ≥ 8g
- Neuroendocrine function is normal
- BMI ≥ 18.5.
- Cancer pain, VAS score \< 3
- Fatigue score ≥ 4
- syndrome differentiation is deficiency of Qi and blood
You may not qualify if:
- Brain metastases with Symptomatic
- Mental disease
- Severe infection
- Insomniacs
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Sun
Peking University Cancer Hospital & Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
December 3, 2021
First Posted
February 8, 2022
Study Start
April 2, 2020
Primary Completion
September 1, 2023
Study Completion
June 30, 2024
Last Updated
January 19, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share