Back to resultsRSYR for Fatigue Reduction in Cancer Fatigue Caused by Chemotherapy (TCM)
Primary Purpose
Cancer-related Problem/Condition
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TCM Formula
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cancer-related Problem/Condition focused on measuring Chemotherapy, Fatigue, Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Brain metastases with Symptomatic
- Mental disease
- Severe infection
- Insomniacs
- Pregnant or lactating women
Sites / Locations
- Beijing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TCM decoction
placebo
Arm Description
Compound granules of Traditional Chinese Medicine
Placebo only
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05229029
First Posted
December 3, 2021
Last Updated
February 6, 2022
Sponsor
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT05229029
Brief Title
RSYR for Fatigue Reduction in Cancer Fatigue Caused by Chemotherapy
Acronym
TCM
Official Title
A Multicenter, Randomized, Double-blind Clinical Trial of TCM in Reducing CRF Caused by Chemotherapy in Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
In this study, symptomatic indicators and quality of life were used as the main evaluation indicators. Patients with moderate to severe CRF who received dual drug chemotherapy were given traditional Chinese medicine compound and placebo intervention respectively. The data of fatigue symptoms, quality of life, sleep quality, blood routine test, liver and kidney function were observed and compared, so as to verify the traditional Chinese medicine compound prescription in improving the CRF symptoms and quality of life of chemotherapy patients validity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Problem/Condition
Keywords
Chemotherapy, Fatigue, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TCM decoction
Arm Type
Experimental
Arm Description
Compound granules of Traditional Chinese Medicine
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo only
Intervention Type
Drug
Intervention Name(s)
TCM Formula
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo made of dextrin and caramel
Primary Outcome Measure Information:
Title
Fatigue score
Description
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.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Brain metastases with Symptomatic
Mental disease
Severe infection
Insomniacs
Pregnant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yichen D Xu
Phone
8601088196273
Ext
8601088196273
Email
xxxxyc@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei D Zhang
Phone
8601088196273
Ext
8601088196273
Email
wtrf0371w@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Sun
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhang
Phone
86-010-88196273
Email
wtrf0371w@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RSYR for Fatigue Reduction in Cancer Fatigue Caused by Chemotherapy
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