Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules

NCT06381557 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: YRPG-PMS-ZYJN-RCT-2022-01
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

Traditional Chinese medicine（TCM） has achieved some meaningful results in improving the symptoms and quality of life of cancer patients, but many research results need to be further verified by clinical trials with larger samples and better design.This study aims to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer.

Conditions

Cancer-related Fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue degree with the Brief Fatigue Inventory（BFI）

  BFI consists of 9 items, each rated from 0 to 10, with fatigue score calculated as the total score divided by 9. A higher score indicates a greater level of fatigue; where 0 indicates no fatigue, 1-3 indicates mild fatigue, 4-6 indicates moderate fatigue, 7-9 indicates severe fatigue, and 10 indicates the most severe fatigue imaginable.In the screening phase, the subjects' fatigue status is assessed using the Brief Fatigue Inventory (BFI). Subjects are required to complete the BFI assessment at a specified time each day for 14 consecutive days and record the assessment results. The Investigators determine the eligibility of subjects based on the average BFI scores over the 14 days, with subjects considered eligible if the BFI average is ≥4 points. During the treatment phase, subjects undergo BFI assessments once a week at specified times (i.e., week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8,) to evaluate their fatigue status.

  8 weeks

Secondary Outcomes (4)

• Fatigue degree the Revised Piper Fatigue Scale（PFS⁃R）

  8 weeks

• Fatigue degree with the MD Anderson Symptom Inventory（MDASI）

  8 weeks

• Change of patients' functional status with Karnofsky performance status (KPS)

  8 weeks

• Quality of Life Questionnaire-Breast Cancer Module 23（QLQ-BR23）

  8 weeks

Other Outcomes (1)

• Adverse reaction rates, including the damage of liver and renal functions that reflected by increased alanine aminotransferase, aspartate aminotransferase and creatinine urea nitrogen respectively

  8 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Drug: Zhengyuan Capsules

Control Group

PLACEBO COMPARATOR

Drug: Placebo contains 5%-10% Zhengyuan Capsule total mixed powder

Interventions

Zhengyuan Capsules DRUG

Zhengyuan capsules, 4 capsules at a time, 3 times per day;

Also known as: A listed Chinese Medicine

Experimental Group

Placebo contains 5%-10% Zhengyuan Capsule total mixed powder DRUG

Zhengyuan capsules simulator（Placebo contains 5%-10% Zhengyuan Capsule total mixed powder）, 4 capsules at a time, 3 times per day;

Also known as: Placebo

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically or cytologically confirmed as breast cancer; AJCC 8th edition staging for breast cancer is stages I to III, clinically and radiologically confirmed with no tumor recurrence or metastasis.
• Completed anti-tumor treatment (surgery, radiotherapy, chemotherapy, targeted therapy) for at least 2 months, with no planned anti-tumor treatment during the study period, excluding endocrine therapy.
• Meets the diagnosis criteria for cancer-related fatigue.
• Average score on the Brief Fatigue Inventory (BFI) in the 14 days preceding enrollment is ≥4.
• Life expectancy of at least 6 months.
• Age between 18 and 70 years old.
• Patients and their families understand the basic details of the study, agree to cooperate in completing the relevant research; the patient can communicate verbally and in writing; voluntary signing of the informed consent form.

You may not qualify if:

• Presence of significant liver or kidney dysfunction (e.g., alanine transaminase, aspartate transaminase greater than 3 times the upper limit of normal, blood creatinine greater than 1.5 times the upper limit of normal, eGFR \<60 mL/min/1.73m²) or abnormalities in the hematological system (platelet count \<75×10⁹/L, hemoglobin \<100g/L, or neutrophil count \<1.5×10⁹/L);
• Presence of severe primary diseases in the cardiovascular, cerebrovascular, immune systems, or requiring treatment for mental illness;
• Hypokalemia (blood potassium \<3.0mmol/L) or electrolyte imbalance with related symptoms or symptoms that may occur after enrollment;
• Unimproved hypothyroidism;
• Hypoalbuminemia (blood albumin \<30g/L) or malnutrition (Body Mass Index, BMI \<18 kg/m²);
• Traditional Chinese medicine syndrome pattern consistent with Yin deficiency and internal heat;
• Use of medications indicated in the instructions or with main functions that meet the following conditions: other Western or Chinese medicine preparations that affect the efficacy evaluation of cancer-related fatigue; undergoing treatment with anti-anemia, anti-anxiety/depression, anti-insomnia, or other psychostimulant drugs; use of drugs with leukocyte-increasing effects within the past week, such as granulocyte colony-stimulating factor (G-CSF);
• Known allergy to the investigational drug or its components;
• Breastfeeding, pregnant, or planning to become pregnant within 3 months;
• The investigator deems the individual unsuitable for participation in this clinical trial.

Sponsors & Collaborators

• Qiang Fu: lead
• Yangtze River Pharmaceutical Group Co., Ltd.: collaborator

Central Study Contacts

Shiying Yu, MD.

CONTACT

+86 13871382805; syyu@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 24, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share