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

Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial is looking into a new treatment option called nano-crystalline megestrol acetate to help patients with advanced gastric or colorectal cancer who are experiencing cancer-related fatigue. The goal is to see if adding this medication to the standard treatment can improve energy levels and overall well-being compared to just the standard treatment alone. The study is currently recruiting participants, and they are seeking individuals aged 18 to 75 years who have specific types of cancer and are dealing with moderate to severe fatigue.

To be eligible for the trial, participants should have been diagnosed with locally advanced or metastatic gastric or colorectal cancer and must not have received previous systemic treatments for these cancers. They should also be experiencing fatigue and have good organ function. Participants can expect to be randomly assigned to either receive the new medication alongside standard treatment or just the standard treatment alone. It’s important to note that certain health conditions or recent treatments may exclude some people from participating. This trial aims to provide valuable information that could lead to better support for patients struggling with fatigue during their cancer treatment.

Gender

ALL

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.