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

NCT ID: NCT06151249

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Metastatic Breast Cancer

Keywords

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Metastatic Breast Cancer Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Chemotherapy+Meritup Chemotherapy+Placebo

Study Groups

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Chemotherapy+Meritup

Chemotherapy+Meritup 20ml TID

Group Type EXPERIMENTAL

Meritup oral solution

Intervention Type COMBINATION_PRODUCT

chemotherapy + Meritup

Chemotherapy+Placebo

Chemotherapy+Placebo 20ml TID

Group Type PLACEBO_COMPARATOR

Meritup oral solution

Intervention Type COMBINATION_PRODUCT

chemotherapy + Meritup

Interventions

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Meritup oral solution

chemotherapy + Meritup

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Phytofound Biotech Co., Ltd.

UNKNOWN

Sponsor Role collaborator

Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming-Hsin Yeh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Central Contacts

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ChihHui Lin, MS

Role: CONTACT

Phone: 0935318221

Email: [email protected]

Other Identifiers

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CSMUH No:CS2-23089

Identifier Type: -

Identifier Source: org_study_id