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RSYR for Fatigue Reduction in Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03911921
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yichen Xu, Beijing Cancer Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer-related Problem/Condition Drug: RSYRT decoction Drug: Astragalus membranaceus Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a randomized Phase II trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Renshen Yangrong Tang (RSYRT) for Reducing Fatigue in Cancer Survivors: A Phase II Randomized Trial
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911921


Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
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Study Director: Pingping Li, Prof. Beijing Cancer Hospital
Principal Investigator: Ting Lu, Dr. Beijing Cancer Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yichen Xu, Research leader, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03911921    
Other Study ID Numbers: FATIGUE
PZ2017019 ( Other Grant/Funding Number: Beijing Municipal Hospital Administration Training Program )
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yichen Xu, Beijing Cancer Hospital:
Fatigue, Cancer
Additional relevant MeSH terms:
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Fatigue