Evaluate the Meritup Oral Solution to Decrease Fatigue in Metastatic Breast Cancer Patients Receiving Chemotherapy

Metastatic Breast Cancer Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Safety and Ability of Meritup Oral Liquid to Reduce Fatigue in Patients With Metastatic Breast Cancer Receiving Chemotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06151249
• Other study ID #: CSMUH No:CS2-23089
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: November 2023
• Source: Chung Shan Medical University
• Contact: ChihHui Lin, MS
• Phone: 0935318221
• Email: wisdomli[@]ms2.hinet.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety profile and ability of Meritup oral solution to decrease fatigue in metastatic breast cancer patients receiving chemotherapy.

Description:

The study population designed to be enrolled is patients with histologically and/or cytologically confirmed breast cancer with clinical evidence of recurrent or progressive metastatic disease and at least completed 3 cycle chemotherapy regimen who have evidence of fatigue.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Female patients over 20years old and under 80 years old.

2. Estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor (HER2), These 3 indicators are all negative.

3. After at least 3 cycles of chemotherapy.

4. Sign the subject Informed Consent Form (ICF).

Exclusion Criteria:

1. Have received other clinical studies within 3 weeks

2. Any uncontrollable infection

3. History of lupus erythematosus, rheumatoid arthritis, ankylosing spondylosis, scleroderma or multiple sclerosis

4. History of cancer cells that have metastasized to the brain

5. Currently receiving a mixture of three or more types of cytotoxic chemotherapy drugs

6. Currently using anti-fatigue treatments, including psychostimulants, acupuncture, etc. Note: Antidepressants are used for treatment to relieve fatigue (such as depression or hot flashes) is allowed,

7. Need to use long-acting sustained-release pain narcotic analgesics

8. Uncontrollable nausea, vomiting or other symptoms that will hinder the ability to speak about the test product

9. Any other serious illness/history that would limit the patient's ability to receive study treatment, as determined by the researcher evaluate

10. Lactation, pregnancy or planning pregnancy

11. People with cardiovascular disease or severe liver and kidney dysfunction should not drink it within one week after surgery.

Related Conditions & MeSH terms

• Breast Neoplasms
• Fatigue
• Metastatic Breast Cancer

Intervention

Combination Product:
• Meritup oral solution
chemotherapy + Meritup

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chung Shan Medical University	Phytofound Biotech Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in fatigue scores	Changes in fatigue scores using the Functional Assessment of Chronic Illness Treatment (FACIT)-Fatigue subscale after 9 weeks of combined chemotherapy treatment	one months
Secondary	Blood test	WBC, RBC, PLT, serum creatinine (SCr), SGOT, SGPT	one month