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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06151249

Enrollment

Registered

2023-11-30

Start date

2023-12-01

Completion date

2025-11-30

Last updated

2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer, Fatigue

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.

Interventions

COMBINATION_PRODUCTMeritup oral solution

chemotherapy + Meritup

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Chemotherapy+Meritup Chemotherapy+Placebo

Intervention model description

An add-on study design to assess the superiority of Meritup over placebo will be utilized in this study to evaluate whether Meritup can decrease fatigue in patients with fatigue. The study will be conducted as a double-blind, randomized trial.

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Blood test	one month	WBC, RBC, PLT, serum creatinine (SCr), SGOT, SGPT

Contacts

Primary ContactChihHui Lin, MS

wisdomli@ms2.hinet.net0935318221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026