Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue

NCT06830018 | Recruiting

• 1 other identifier: MGA- Fatigue-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for the first-line treatment of patients with cancer-related fatigue in gastric or colorectal cancer.

Conditions

Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment

Keywords

cancer-related fatigue， cancer-caused fatigue，fatigue，appetite stimulants; gastric cancer，colorectal cancer，gastrointestinal tumor，cancer，tumor，carcinoma，; nano-crystalline megestrol acetate，megestrol，megestrol acetate，; antineoplastic agents, hormonal，central nervous system stimulants，appetite stimulants

Outcome Measures

Primary Outcomes (2)

• the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV).

  week 6

• the difference in improvement of appetite based on A/CS-12 assessment

  week 6

Study Arms (2)

Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy

EXPERIMENTAL

Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Combination Product: Standard Treatment

Standard Therapy

ACTIVE COMPARATOR

Combination Product: Standard Treatment

Interventions

Nano-crystalline Megestrol Acetate Oral Suspension DRUG

Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day), and continues medication; after completing the treatment cycle, patients who are assessed by the researchers as suitable for continued treatment may continue to receive therapy.

Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy

Standard Treatment COMBINATION_PRODUCT

Standard Treatment，First-line treatment (chemotherapy + immunotherapy/targeted therapy)

Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy; Standard Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤75 years.
• Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2.
• Expected survival ≥ 6 months.
• Locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal adenocarcinoma not amenable to radical treatment with histologic or cytologic confirmation.
• No prior systemic systemic antitumor therapy for gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal cancer.
• Have at least one measurable tumor lesion according to RECIST v1.1.
• Compliance with a Fatigue Visual Analog Scale (VAS) score of ≥ 4 (consistent with moderate or severe fatigue).
• Complain of anorexia.
• Good organ function as determined by the following requirements.

You may not qualify if:

• Suffered significant surgery or traumatic injuries within the past 1month.
• Having any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrollable vomiting.
• currently undergoing tube feeding or parenteral nutrition.
• Suffering from anorexia due to neurosis, mental illness, or difficulty eating due to pain.
• Received erythropoietin or blood transfusion within the past 1month.
• Comorbidities such as serious cerebrovascular, heart, kidney, or liver disease.
• A history of hypersensitivity to the components of the trial medication.
• Other conditions that were considered inappropriate as determined by the investigators.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Hospital Of China Medical University

Shenyang, Liaoning, 110000, China

RECRUITING

Central Study Contacts

Xiujuan Qu

CONTACT

024-83281560; xjqu@cmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: January 23, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-01

Locations

CN (1)