NCT06151249

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

November 21, 2023

Last Update Submit

November 29, 2023

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast CancerFatigue

Outcome Measures

Primary Outcomes (1)

  • Changes in fatigue scores

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

    one months

Secondary Outcomes (1)

  • Blood test

    one month

Study Arms (2)

Chemotherapy+Meritup

EXPERIMENTAL

Chemotherapy+Meritup 20ml TID

Combination Product: Meritup oral solution

Chemotherapy+Placebo

PLACEBO COMPARATOR

Chemotherapy+Placebo 20ml TID

Combination Product: Meritup oral solution

Interventions

Meritup oral solutionCOMBINATION_PRODUCT

chemotherapy + Meritup

Chemotherapy+MeritupChemotherapy+Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients over 20years old and under 80 years old.
  • Estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor (HER2), These 3 indicators are all negative.
  • After at least 3 cycles of chemotherapy.
  • Sign the subject Informed Consent Form (ICF).

You may not qualify if:

  • Have received other clinical studies within 3 weeks
  • Any uncontrollable infection
  • History of lupus erythematosus, rheumatoid arthritis, ankylosing spondylosis, scleroderma or multiple sclerosis
  • History of cancer cells that have metastasized to the brain
  • Currently receiving a mixture of three or more types of cytotoxic chemotherapy drugs
  • 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,
  • Need to use long-acting sustained-release pain narcotic analgesics
  • Uncontrollable nausea, vomiting or other symptoms that will hinder the ability to speak about the test product
  • Any other serious illness/history that would limit the patient's ability to receive study treatment, as determined by the researcher evaluate
  • Lactation, pregnancy or planning pregnancy
  • People with cardiovascular disease or severe liver and kidney dysfunction should not drink it within one week after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ming-Hsin Yeh, MD, PhD

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ChihHui Lin, MS

CONTACT

0935318221wisdomli@ms2.hinet.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Chemotherapy+Meritup Chemotherapy+Placebo
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2023

First Posted

November 30, 2023

Study Start

December 1, 2023

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share