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Efficacy and Safety of Netupitant and Palonosetron Hydrochloride Capsules in Preventing Nausea and Vomiting Induced by Radiochemotherapy in Head and Neck Squamous Cell Carcinoma | Clinical Trials | Clareo Health

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Efficacy and Safety of Netupitant and Palonosetron Hydrochloride Capsules in Preventing Nausea and Vomiting Induced by Radiochemotherapy in Head and Neck Squamous Cell Carcinoma

NCT06102447•Sichuan Cancer Hospital and Research Institute

View on ClinicalTrials.gov

Summary

The enrolled head and neck squamous cell carcinoma patients in this study received high-dose multiday chemotherapy with cisplatin and synchronous radiation therapy, which had a high risk of nausea and vomiting. On the first and third days, they took Netopitam Palonosetron capsules and dexamethasone to reduce the incidence of acute vomiting. The aim of this study is to evaluate the antiemetic effect of Netopitam Palonosetron capsules and to explore the effectiveness of using Netopitam Palonosetron capsules again for antiemetic treatment during the study period when breakthrough vomiting occurs.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, aged 18-75 years old;
•2. Head and neck tumors confirmed by histology or cytology (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer);
•3. Receive radical synchronous radiotherapy and chemotherapy;
•4. The Eastern Oncology Collaborative Group (ECOG) physical fitness score of the subjects was ≤ 2 points;
•5. Adequate organ and bone marrow function;
•6. The expected life is at least 12 weeks;
•7. Pregnant or fertile patients (male or female) use reliable contraceptive measures;
•8. When screening female patients with potential pregnancy, the pregnancy test must be negative;
•9. The subjects voluntarily and strictly comply with the requirements of the research protocol and sign a written informed consent form.

Exclusion Criteria

•1. Recurrent and metastatic head and neck tumors;
•2. Previously underwent tumor resection surgery for treatment;
•3. Patients with platinum drug intolerance;
•4. Receiving any known or potential antiemetic medication within 24 hours prior to the first day, or experiencing symptoms of vomiting, retching, or mild nausea within 24 hours prior to the first day;
•5. Take NK1（neurokinin-1） receptor antagonists or any study medication within 4 weeks before the start of the experiment;
•6. Use CYP3A4 inducer within 4 weeks before chemotherapy, and use CYP3A4 substrate or strong or moderate CYP3A4 inhibitor within 1 week;
•7. Serious cardiovascular, pulmonary, diabetes, mental and other diseases;
•8. Pregnant or lactating women, patients with fertility who are unwilling or unable to take effective contraceptive measures;
•9. Drug and/or alcohol abuse;
•10. Hypocalcemia or any other condition that may cause vomiting;
+4 more criteria

Locations (1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, China

Key Dates

Start Date

November 1, 2023

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2026

Last Updated

October 26, 2023

Enrollment

ESTIMATED participants

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

Netopitam Palonosetron capsules and dexamethasone

DRUG

Contacts

Yangkun Luo

CONTACT

13518161979 621199521@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Netupitant and Palonosetron Hydrochloride Capsules in Preventing Nausea and Vomiting Induced by Radiochemotherapy in Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

AK129 Combination Therapy for Advanced Solid Tumors

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