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

• Sponsor: Chung Shan Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06151249
• Collaborator: Phytofound Biotech Co., Ltd. (Other)
• Enrollment: 32
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Combination Product: Meritup oral solution	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• 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.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.
• Masking: Single (Participant)
• Masking Description: Chemotherapy+Meritup Chemotherapy+Placebo
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Nov 30, 2025
• Anticipated Study Completion Date: Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chemotherapy+Meritup Chemotherapy+Meritup 20ml TID	Combination Product: Meritup oral solution; chemotherapy + Meritup
Placebo Comparator: Chemotherapy+Placebo Chemotherapy+Placebo 20ml TID	Combination Product: Meritup oral solution; chemotherapy + Meritup

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Blood test [one month]

   WBC, RBC, PLT, serum creatinine (SCr), SGOT, SGPT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Chung Shan Medical University
• Phytofound Biotech Co., Ltd.

Investigators

• Principal Investigator: Ming-Hsin Yeh, MD, PhD, Chung Shan Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chung Shan Medical University
• ClinicalTrials.gov Identifier: NCT06151249
• Other Study ID Numbers: CSMUH No:CS2-23089
• First Posted: Nov 30, 2023
• Last Update Posted: Nov 30, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chung Shan Medical University: Metastatic Breast Cancer; Fatigue
• Additional relevant MeSH terms: Breast Neoplasms; Fatigue

Study Results

No Results Posted as of Nov 30, 2023