RSYR for Fatigue Reduction in Cancer Fatigue Caused by Chemotherapy

Phase 2

Active, not recruiting

• Conditions: Cancer-related Problem/Condition
• Interventions: Drug: TCM Formula; Drug: Placebo

• Registration Number: NCT05229029
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

This is a multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of Chinese herbal compound in improving fatigue symptoms and quality of life in patients with chemotherapy.

Detailed Description

In this study, symptomatic indicators and quality of life were used as the main evaluation indicators. Patients with moderate to severe CRF who received dual drug chemotherapy were given traditional Chinese medicine compound and placebo intervention respectively. The data of fatigue symptoms, quality of life, sleep quality, blood routine test, liver and kidney function were observed and compared, so as to verify the traditional Chinese medicine compound prescription in improving the CRF symptoms and quality of life of chemotherapy patients validity.

Study Timeline

• Study Start: 2020-04-02
• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2022-02-06
• Study First Posted: 2022-02-08
• Primary Completion: 2023-09-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-19
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Malignant tumor patients with pathological diagnosis
• Men and women aged 18-75
• KPS score ≥ 70, expected survival time more than 6 months
• The function of heart, lung, liver and kidney was normal
• Hemoglobin ≥ 8g
• Neuroendocrine function is normal
• BMI ≥ 18.5.
• Cancer pain, VAS score < 3
• Fatigue score ≥ 4
• syndrome differentiation is deficiency of Qi and blood

Exclusion Criteria

• Brain metastases with Symptomatic
• Mental disease
• Severe infection
• Insomniacs
• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCM decoction	TCM Formula	Compound granules of Traditional Chinese Medicine
placebo	Placebo	Placebo only

Primary Outcome Measures

Name	Time	Method
Fatigue score	21 days	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.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China