RSYR for Fatigue Reduction in Cancer Survivors

April 12, 2019 updated by: Yichen Xu, Peking University Cancer Hospital & Institute

Renshen Yangrong Tang (RSYRT) for Reducing Fatigue in Cancer Survivors: A Phase II Randomized Trial

This randomized Phase II trial to establish the efficacy of traditional Chinese medicine (TCM) herbal products above control group for treating fatigue in patients with cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who were randomized and been enrolled in, had stable disease and no anemia, and reported moderate to severe fatigue over two months (rated ≥4 on a 0-10 scale). Patients took TCM decoction Renshen Yangrong decoction (RSYR),Which containing 12 TCM herbs, twice a day for 6 weeks. RSYRT aims to correct Qi deficiency. Fatigue was assessed before and after RSYRT therapy.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Pathological diagnosis of malignant tumors; 3 months without surgery, radiotherapy and chemotherapy, biological treatment; Hemoglobin > 11g/L; Complete remission of the lesion, or recent review of the Disease is stable, the estimated survival time is more than 6 months; ECOG score is 0-2, fatigue score of the last 24 hours > 4 ; Age is 18-65 years old; TCM syndrome differentiation for deficiency of qi; Liver, kidney function, electrolyte normal; Willing to join the group and sign the informed consent.

Exclusion Criteria:

Allergies to herbs and plant drugs; Uncontrollable diabetes, hypertension, TSH abnormalities, uncontrollable pain, and a history of myocardial infarction within 6 months; Scores of anxiety disorders and depression (HAD-D) were 11 or more, antidepressants and antioxidants were used in the past month; Breast cancer receptor positive patients took endocrine therapy drugs; Tonics were used in the past 2 weeks.; Children, pregnant and lactating women; Receiving anemia-related treatment; Chinese medicine syndrome differentiation with excessive heat; Unable to read or understand the scale.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RSYYT decoction
RSYYT decoction Compound granules of traditional Chinese medicine
Drug: RSYRT decoction
Compound granules of traditional Chinese medicine
Experimental: Astragalus membranaceus
one herb decoction Compound granules of one herb (Astragalus membranaceus)
Drug: Astragalus membranaceus
One herb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue score
Time Frame: 6 weeks
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.
6 weeks

Collaborators and Investigators

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

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Study Director: Pingping Li, Prof., Peking University Cancer Hospital & Institute
  • Principal Investigator: Ting Lu, Dr., Peking University Cancer Hospital & Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2015

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fatigue
  • PZ2017019 (Other Grant/Funding Number: Beijing Municipal Hospital Administration Training Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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