RSYR for Fatigue Reduction in Cancer Survivors

NCT ID: NCT03911921

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2019-02-01

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.

Conditions

Cancer-related Problem/Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RSYYT decoction

RSYYT decoction Compound granules of traditional Chinese medicine

Group Type: EXPERIMENTAL

RSYRT decoction

Intervention Type: DRUG

Compound granules of traditional Chinese medicine

Astragalus membranaceus

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

Group Type: EXPERIMENTAL

Astragalus membranaceus

Intervention Type: DRUG

One herb

Interventions

RSYRT decoction

Compound granules of traditional Chinese medicine

Intervention Type: DRUG

Astragalus membranaceus

One herb

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Yichen Xu

Research leader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pingping Li, Prof.

Role: STUDY_DIRECTOR

Peking University Cancer Hospital & Institute

Ting Lu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

References

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.

Reference Type: DERIVED

PMID: 31668965 (View on PubMed)

Other Identifiers

PZ2017019

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FATIGUE

Identifier Type: -

Identifier Source: org_study_id