RSYR for Fatigue Reduction in Cancer Survivors

Phase 2

Completed

• Conditions: Cancer-related Problem/Condition
• Interventions: Drug: RSYRT decoction; Drug: Astragalus membranaceus

• Registration Number: NCT03911921
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-11
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RSYYT decoction	RSYRT decoction	RSYYT decoction Compound granules of traditional Chinese medicine
Astragalus membranaceus	Astragalus membranaceus	one herb decoction Compound granules of one herb (Astragalus membranaceus)

Primary Outcome Measures

Name	Time	Method
Fatigue score	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.