RSYR for Fatigue Reduction in Cancer Fatigue Caused by Chemotherapy (TCM)

January 17, 2024 updated by: Sun Hong, Peking University Cancer Hospital & Institute

A Multicenter, Randomized, Double-blind Clinical Trial of TCM in Reducing CRF Caused by Chemotherapy in Cancer Patients

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yichen D Xu
  • Phone Number: 8601088196273 8601088196273
  • Email: xxxxyc@126.com

Study Contact Backup

  • Name: Wei D Zhang
  • Phone Number: 8601088196273 8601088196273
  • Email: wtrf0371w@126.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TCM decoction
Compound granules of Traditional Chinese Medicine
Drug: TCM Formula
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.
Other Names:
  • RSYR decoction
Placebo Comparator: placebo
Placebo only
Drug: Placebo
Mainly made of dextrin and caramel, containing 1/30 concentration of experimental group drugs
Other Names:
  • Placebo dicoction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue score
Time Frame: 21 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Hong Sun, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2020

Primary Completion (Actual)

September 1, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

February 6, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEM FATI
  • SF2020-2-1023 (Other Grant/Funding Number: Beijing Science and Technology Commission)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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