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

Chung Shan Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Combination Product: Meritup oral solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06151249

CSMUH No:CS2-23089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups, including a placebo group

Chemotherapy+Meritup

Experimental group

Description:

Chemotherapy+Meritup 20ml TID

Treatment:

Combination Product: Meritup oral solution

Chemotherapy+Placebo

Placebo Comparator group

Description:

Chemotherapy+Placebo 20ml TID

Treatment:

Combination Product: Meritup oral solution