Clinical trial · Interventional
Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension | Drug | — | UNRESOLVED |
| Standard Treatment | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy
- interventionNames
- Drug: Nano-crystalline Megestrol Acetate Oral Suspension
- Combination Product: Standard Treatment
- type
- ACTIVE_COMPARATOR
- label
- Standard Therapy
- interventionNames
- Combination Product: Standard Treatment
Primary outcomes (2)
- measure
- the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV).
- timeFrame
- week 6
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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