search
Back to results

RSYR for Fatigue Reduction in Cancer Survivors

Primary Purpose

Cancer-related Problem/Condition

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
RSYRT decoction
Astragalus membranaceus
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer-related Problem/Condition focused on measuring Fatigue, Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    RSYYT decoction

    Astragalus membranaceus

    Arm Description

    RSYYT decoction Compound granules of traditional Chinese medicine

    one herb decoction Compound granules of one herb (Astragalus membranaceus)

    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

    First Posted
    April 10, 2019
    Last Updated
    April 12, 2019
    Sponsor
    Peking University Cancer Hospital & Institute
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03911921
    Brief Title
    RSYR for Fatigue Reduction in Cancer Survivors
    Official Title
    Renshen Yangrong Tang (RSYRT) for Reducing Fatigue in Cancer Survivors: A Phase II Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2015 (Actual)
    Primary Completion Date
    February 1, 2019 (Actual)
    Study Completion Date
    February 1, 2019 (Actual)

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer-related Problem/Condition
    Keywords
    Fatigue, Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    a randomized Phase II trial
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    92 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RSYYT decoction
    Arm Type
    Experimental
    Arm Description
    RSYYT decoction Compound granules of traditional Chinese medicine
    Arm Title
    Astragalus membranaceus
    Arm Type
    Experimental
    Arm Description
    one herb decoction Compound granules of one herb (Astragalus membranaceus)
    Intervention Type
    Drug
    Intervention Name(s)
    RSYRT decoction
    Intervention Description
    Compound granules of traditional Chinese medicine
    Intervention Type
    Drug
    Intervention Name(s)
    Astragalus membranaceus
    Intervention Description
    One herb
    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
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pingping Li, Prof.
    Organizational Affiliation
    Peking University Cancer Hospital & Institute
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ting Lu, Dr.
    Organizational Affiliation
    Peking University Cancer Hospital & Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31668965
    Citation
    Xu Y, Wang XS, Chen Y, Shi Q, Chen TH, Li P. A Phase II Randomized Controlled Trial of Renshen Yangrong Tang Herbal Extract Granules for Fatigue Reduction in Cancer Survivors. J Pain Symptom Manage. 2020 May;59(5):966-973. doi: 10.1016/j.jpainsymman.2019.10.018. Epub 2019 Oct 24.
    Results Reference
    derived

    Learn more about this trial

    RSYR for Fatigue Reduction in Cancer Survivors

    We'll reach out to this number within 24 hrs