Actively Recruiting
A Prospective, Randomized, Parallel-Controlled Study of Nanocrystalline Megestrol Acetate with Concurrent Chemoradiotherapy in Locally Advanced Cervical Cancer
Led by Second Xiangya Hospital of Central South University · Updated on 2026-04-24
88
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Locally advanced cervical cancer is a common cancer in women worldwide and often leads to serious nutritional problems like malnutrition and cachexia. This condition worsens during concurrent chemoradiotherapy (CCRT), especially due to treatments like platinum-based drugs, which cause muscle loss and weight loss, increasing mortality risk. Researchers are studying nanocrystalline megestrol acetate (MA), a drug that may help stimulate appetite and reduce inflammation, aiming to improve nutritional status and treatment outcomes in these patients. This clinical trial compares two groups of patients with locally advanced cervical cancer undergoing CCRT: one group will receive nanocrystalline megestrol acetate oral suspension at 625 mg daily for up to 8 weeks, and the other will receive CCRT alone. The nanocrystalline form of MA has better absorption and faster onset of effect than traditional forms, potentially leading to improved weight gain and reduced muscle wasting. The study will measure body mass index (BMI), appetite, lean body mass, treatment completion, and side effects related to radiotherapy. Participants will be monitored for changes in BMI during the 8-week treatment period, alongside assessments of appetite using a specific scale, survival rates, and inflammatory markers. Regular lab tests will evaluate organ function and safety. The trial will also track adverse events and quality of life. The total participation duration for each patient is up to 8 weeks of treatment, with ongoing assessments to understand the drug's impact on nutrition and cancer treatment tolerance.
CONDITIONS
Brief Title
A Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Voluntarily sign informed consent form
- ECOG performance status score of 0 to 2
- Expected survival of at least 6 months
- Histologically or cytologically confirmed locally advanced cervical cancer (Stage IB3/IIA2/IIB-IVA) not suitable for complete surgery
- Scheduled for radical concurrent chemoradiotherapy
- At least one measurable tumor lesion per RECIST v1.1
- Adequate organ function including blood counts, kidney, liver, coagulation, and heart function
- Negative pregnancy test for women of childbearing potential and use of contraceptives as required
- Willing and able to comply with study visits, treatments, and tests
You will not qualify if you...
- Conditions affecting gastrointestinal absorption such as difficulty swallowing, malabsorption, uncontrolled vomiting, or tube feeding
- Current or planned use of appetite or weight-increasing medications except short-term dexamethasone during chemotherapy
- Diagnosis of Cushing's syndrome, adrenal or pituitary insufficiency, or poorly controlled diabetes
- Evidence of gastrointestinal obstruction
- Active autoimmune disease requiring recent systemic treatment or history of serious lung inflammation
- Uncontrolled illnesses including severe liver, kidney, metabolic, peptic ulcer, psychiatric, or social conditions limiting study participation
- Recent serious heart conditions, vascular diseases, gastrointestinal bleeding, or ulcers
- Recent arterial or venous thromboembolic events or severe hypertension despite therapy
- History of severe bleeding disorders or recent significant bleeding
- Recent severe infections requiring hospitalization or systemic antimicrobial therapy
- Any other condition or abnormality that could affect study results or participant safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks or until disease progression
Participants receive Nanocrystalline Megestrol Acetate Oral Suspension daily along with concurrent chemoradiotherapy.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
Xiangya Second Hospital of Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
Research Team
J
jingjing Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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