RSYR for Fatigue Reduction in Cancer Survivors

Cancer-related Problem/Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911921
• Other study ID #: FATIGUE
• Secondary ID: PZ2017019
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2015
• Est. completion date: February 1, 2019

Study information

• Verified date: April 2019
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer-related Problem/Condition
• Fatigue

Intervention

Drug:
• RSYRT decoction
Compound granules of traditional Chinese medicine
• Astragalus membranaceus
One herb

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks