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

Phase 2

Not yet recruiting

• Conditions: Metastatic Breast Cancer
• Interventions: Combination Product: Meritup oral solution

• Registration Number: NCT06151249
• Lead Sponsor: Chung Shan Medical University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study First Posted: 2023-11-30
• Last Update Posted: 2023-11-30
• Study Start: 2023-12-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy+Meritup	Meritup oral solution	Chemotherapy+Meritup 20ml TID
Chemotherapy+Placebo	Meritup oral solution	Chemotherapy+Placebo 20ml TID

Primary Outcome Measures

Name	Time	Method
Changes in fatigue scores	one months	Changes in fatigue scores using the Functional Assessment of Chronic Illness Treatment (FACIT)-Fatigue subscale after 9 weeks of combined chemotherapy treatment

Secondary Outcome Measures

Name	Time	Method
Blood test	one month	WBC, RBC, PLT, serum creatinine (SCr), SGOT, SGPT