Nanocrystalline Megestrol for First-line Treatment of Adv... | NCT06830018

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

NCT06830018

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Feb 17, 2025Actual

Enrollment

76Estimated

Phase

Not Applicable

Conditions

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

Interventions

Nano-crystalline Megestrol Acetate Oral Suspension
Standard Treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2025Actual

Primary Completion Date

Jan 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Feb 11, 2025

First Submission Date that Met QC Criteria

Feb 14, 2025

First Posted Date

Feb 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2025

Last Update Posted Date

Feb 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided