Clinical trial NCT06830018: Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue
Official title: A Multicenter, Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment Alone for the First-line Treatment of Patients With Cancer-related Fatigue In Gastric Or Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV).
timeFrame: week 6
measure: the difference in improvement of appetite based on A/CS-12 assessment
timeFrame: week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Hospital Of China Medical University
state: Liaoning
Study officials:
References: