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A single-center, randomized controlled, Phase III,prospective clinical observation study on dexamethasone individualized application of cervical cancer during chemoradiotherapy

A single-center, randomized controlled, Phase III,prospective clinical observation study on dexamethasone individualized application of cervical cancer during chemoradiotherapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105475
Enrollment
Unknown
Registered
2025-07-03
Start date
2024-10-30
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Interventions

Experimental group B :If the nausea and vomiting score in the first cycle is 0, the patient will be randomly assigned to Group A using a random number method: the dexamethasone dose unadjusted triple
Or Group B: Individualized adjustment of dexamethasone dosage in the triple antiemetic group. For experimental group B, the hormone dosage should be reduced by at least one day in the second week
If the nausea and vomiting score is 0, the same reduction can be made in the third week. If the nausea and vomiting score is upgraded, it is not recommended to reduce the dosage and can be salvaged
The number of days to resume hormone use in the next cycle
Based on the classification of nausea and vomiting, determine whether to reduce the duration of hormone use in the next cycle until the end of the synchronous chemotherapy cycle
The total observation period is 7 weeks, and observation will be stopped 2 weeks after the end of cisplatin synchronous chemotherapy.
control group A:If the nausea and vomiting score in the first cycle is 0, the patient will be randomly assigned to Group A using a random number method

Sponsors

Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Participants must meet all of the following conditions in order to be enrolled. 1. Age over 18 years old and under 70 years old; 2. The subjects must be diagnosed with cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous cell carcinoma through histopathological examination; There are no contraindications for radiotherapy and chemotherapy. For patients who plan to undergo postoperative or radical pelvic radiotherapy and chemotherapy, the synchronous cisplatin regimen is 40 mg/m2 qw. 3. Having sufficient organ and bone marrow function: (1). Hemoglobin>9g/dL in the past 14 days without blood transfusion or use of erythropoietin; (2). Absolute neutrophil count (ANC) >= 1.5 × 10^9/L without using granulocyte colony-stimulating factor in the past 14 days; (3). Platelet count (PLT) >= 9 × 10^9/L without blood transfusion within the past 14 days; (4). Total bilirubin (TBIL) = 50mL/min (Cockcroft Gault formula); 4. The patient chooses a triple antiemetic regimen, which includes NK-1 receptor inhibitors, 5-HT, and dexamethasone acetate; 5. Capable of independently signing informed consent forms; 6. Capable of follow-up and good compliance.

Exclusion criteria

Exclusion criteria: If the subject has any of the following conditions, they will be excluded from the group; 1. Patients with suspected intestinal obstruction and dizziness; Or for patients undergoing extended field radiotherapy; 2. There are contraindications to the use of hormones; 3. Combination use of NK-1 contraindicated medication patients; Patients who use morphine drugs for pain relief simultaneously; 4. Acute exacerbation of chronic pharyngitis; 5. There are other diseases that can easily cause nausea and vomiting; Including psychosomatic diseases; 6. Medical history or disease evidence (poorly controlled hypertension, severe heart disease, etc.) that may interfere with the trial results, hinder the full participation of the subjects in the study, abnormal treatment or laboratory test values, or other situations that the researchers believe are not suitable for inclusion. The researchers believe that there are other potential risks that are not suitable for participation in this study; 7. Unable to sign informed consent form; 8. Has received radiotherapy and chemotherapy; 9. Merge with other malignant tumors.

Design outcomes

Primary

MeasureTime frame
Adverse events;Complete prevention rate;Complete remission and rate;

Countries

China

Contacts

Public ContactSong Xuemei

Affiliated Hospital of Southwest Medical University

522389830@qq.com+86 180 0823 4836

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026