Cancer-related FatiguePhase 4CRFNCT06381557
Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules
A Phase 4 study testing Zhengyuan Capsules in people with Cancer-related Fatigue, run by Qiang Fu.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cancer-related Fatigue
- What is being tested?
- Zhengyuan Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study on the Effectiveness and Safety of Zhengyuan Capsules for Cancer-related Fatigue in Patients With Breast Cancer
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.
Read the detailed description
By conducting multi-center, randomized, double-blind, placebo-controlled clinical research to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer.This test choose the improvement of fatigue degree as key indicator, and choose the improvement both symptoms of patients and quality of life as second indicators. And last, the study will try to verify its safety and efficacy with some haematological indexs and reveal its mechanism from the perspectives of Cytokines and immunological indicators, so as to explore the advantages of traditional Chinese medicine（TCM） in the treatment of CRF and support some high quality, internationally recognized clinical evidence.
- Conditions
- Cancer-related Fatigue
- Being tested
- Zhengyuan Capsules, Placebo contains 5%-10% Zhengyuan Capsule total mixed powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zhengyuan CapsulesDrug
Also called A listed Chinese Medicine
Zhengyuan capsules, 4 capsules at a time, 3 times per day;
Placebo contains 5%-10% Zhengyuan Capsule total mixed powderDrug
Also called Placebo
Zhengyuan capsules simulator（Placebo contains 5%-10% Zhengyuan Capsule total mixed powder）, 4 capsules at a time, 3 times per day;
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Drug: Zhengyuan Capsules |
| Control Group | Placebo comparator | Not described Receives: Drug: Placebo contains 5%-10% Zhengyuan Capsule total mixed powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
Fatigue degree the Revised Piper Fatigue Scale（PFS⁃R）
PFS-R is derived from the Piper Fatigue Scale by reducing the number of items. It includes 22 items assessing behavior, emotion, sensation, and cognition. Each question is cored from 0 to10 points, where a higher score indicates severe symptoms; 1 to 3 point is mild, 4 to 6 point is moderate, and 7 to 10 point is severe. , resulting in a total fatigue score ranging from 0 to 220. The average score is calculated by dividing the total score by 22. A higher score indicates greater fatigue.Treatment follow-up: Subjects are required to visit the clinic for Visit 3 (4 weeks ± 3 days after medication) and Visit 5 (8 weeks ± 3 days after medication). For Visit 1 (1 week ± 1 day after medication), Visit 2 (2 weeks ± 1 day after medication), and Visit 4 (6 weeks ± 1 day after medication), researchers will conduct follow-up via telephone to assess the subject's condition, encourage, and assist in completing the assessment and recording of the PFS-R scale.
Measured: 8 weeks
Fatigue degree with the MD Anderson Symptom Inventory（MDASI）
MDASI is used to assess various symptoms and discomfort experienced by cancer patients during their treatment. Each question is cored from 0 to10 points, where 0 indicates no symptoms or symptoms without interference, and 10 indicates symptoms reaching the most severe imaginable level and causing severe interference. A higher total score indicates more severe symptoms and higher distress from symptoms.Treatment follow-up: Subjects are required to visit the clinic for Visit 3 (4 weeks ± 3 days after medication) and Visit 5 (8 weeks ± 3 days after medication). For Visit 1 (1 week ± 1 day after medication), Visit 2 (2 weeks ± 1 day after medication), and Visit 4 (6 weeks ± 1 day after medication), researchers will conduct follow-up via telephone to assess the subject's condition, encourage, and assist in completing the assessment and recording of the MDASI scale.
Measured: 8 weeks
Change of patients' functional status with Karnofsky performance status (KPS)
KPS Scores ranged from 100 to 0,The higher score represent the better health, the more likely that you are able to tolerate the side effects of treatment. It is generally considered that Karnofsky80 score or above represent patients can live independently, 60~80 score represent semi-independently, Under 60 represent patients often need help in living.KPS scores should be measured at the baseline, 4 weeks, 8 weeks.
Measured: 8 weeks
Quality of Life Questionnaire-Breast Cancer Module 23（QLQ-BR23）
The EORTC QLQ-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.Each question is cored from 0 to 4points, where 0 indicates no symptoms or symptoms without interference, and 4 indicates symptoms reaching the most severe imaginable level and causing severe interference. QLQ-BR23 were recorded at the baseline and 8 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiang Fu
- Sponsor type
- University, hospital or other
- Collaborators
- Yangtze River Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor-investigator, Qiang Fu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381557
- Sponsor's protocol ID
- YRPG-PMS-ZYJN-RCT-2022-01
- Acronym
- CRF
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study on the Effectiveness and Safety of Zhengyuan Capsules for Cancer-related Fatigue in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT06381557
- Acronym / sponsor ID
- CRF / YRPG-PMS-ZYJN-RCT-2022-01
- Conditions
- Cancer-related Fatigue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Qiang FuUniversity, hospital or other
- Collaborators
- Yangtze River Pharmaceutical Group Co., Ltd.
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
By conducting multi-center, randomized, double-blind, placebo-controlled clinical research to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer.This test choose the improvement of fatigue degree as key indicator, and choose the improvement both symptoms of patients and quality of life as second indicators. And last, the study will try to verify its safety and efficacy with some haematological indexs and reveal its mechanism from the perspectives of Cytokines and immunological indicators, so as to explore the advantages of traditional Chinese medicine（TCM） in the treatment of CRF and support some high quality, internationally recognized clinical evidence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Zhengyuan Capsules |
| Control Group | Placebo comparator | Drug: Placebo contains 5%-10% Zhengyuan Capsule total mixed powder |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zhengyuan CapsulesAlso: A listed Chinese MedicineZhengyuan capsules, 4 capsules at a time, 3 times per day; | Drug | Experimental Group |
| Placebo contains 5%-10% Zhengyuan Capsule total mixed powderAlso: PlaceboZhengyuan capsules simulator（Placebo contains 5%-10% Zhengyuan Capsule total mixed powder）, 4 capsules at a time, 3 times per day; | Drug | Control Group |
Primary outcome
Fatigue degree with the Brief Fatigue Inventory（BFI）
Time frame: 8 weeks
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.
4 secondary outcomes
Fatigue degree the Revised Piper Fatigue Scale（PFS⁃R）
Time frame: 8 weeks
Fatigue degree with the MD Anderson Symptom Inventory（MDASI）
Time frame: 8 weeks
Change of patients' functional status with Karnofsky performance status (KPS)
Time frame: 8 weeks
Quality of Life Questionnaire-Breast Cancer Module 23（QLQ-BR23）
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zhengyuan Capsules in people with Cancer-related Fatigue, run by Qiang Fu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiying Yu, MD. (+86 13871382805, syyu@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue degree with the Brief Fatigue Inventory（BFI） (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.