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Trial Title:
Evaluate the Meritup Oral Solution to Decrease Fatigue in Metastatic Breast Cancer Patients Receiving Chemotherapy
NCT ID:
NCT06151249
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Fatigue
Conditions: Keywords:
Metastatic Breast Cancer
Fatigue
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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.
Primary purpose:
Treatment
Masking:
Single (Participant)
Masking description:
Chemotherapy+Meritup Chemotherapy+Placebo
Intervention:
Intervention type:
Combination Product
Intervention name:
Meritup oral solution
Description:
chemotherapy + Meritup
Arm group label:
Chemotherapy+Meritup
Arm group label:
Chemotherapy+Placebo
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
December 1, 2023
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Chung Shan Medical University
Agency class:
Other
Collaborator:
Agency:
Phytofound Biotech Co., Ltd.
Agency class:
Other
Source:
Chung Shan Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06151249
