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 | Unknown

• 1 other identifier: SCCHEC-02-2023-076
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Outcome Measures

Primary Outcomes (1)

• The complete response rate during synchronous radiotherapy and chemotherapy (defined as no vomiting episodes and no emergency medication).

  1 month

Secondary Outcomes (7)

• No significant nausea rate during synchronous radiotherapy and chemotherapy

  1 month

• Nausea free rate during synchronous radiotherapy and chemotherapy

  1 month

• No vomiting rate during synchronous radiotherapy and chemotherapy

  1 month

• The rate of non emergency medication during synchronous radiotherapy and chemotherapy

  1 month

• The prevalence and severity of oral/oropharyngeal mucositis during synchronous radiotherapy and chemotherapy

  1 month

Study Arms (1)

Treatment Group

EXPERIMENTAL

Drug: Netopitam Palonosetron capsules and dexamethasone

Interventions

Netopitam Palonosetron capsules and dexamethasone DRUG

On the first and third days, they took Netopitam Palonosetron capsules and dexamethasone to reduce the incidence of acute vomiting.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Recurrent and metastatic head and neck tumors;
• Previously underwent tumor resection surgery for treatment;
• Patients with platinum drug intolerance;
• 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;
• Take NK1（neurokinin-1） receptor antagonists or any study medication within 4 weeks before the start of the experiment;
• Use CYP3A4 inducer within 4 weeks before chemotherapy, and use CYP3A4 substrate or strong or moderate CYP3A4 inhibitor within 1 week;
• Serious cardiovascular, pulmonary, diabetes, mental and other diseases;
• Pregnant or lactating women, patients with fertility who are unwilling or unable to take effective contraceptive measures;
• Drug and/or alcohol abuse;
• Hypocalcemia or any other condition that may cause vomiting;
• There are significant factors that affect the absorption of oral medication, such as chronic diarrhea and intestinal obstruction;
• The subject has allergic reactions to Netopitam Palonosetron capsules or any of their excipients;
• Within 30 days prior to the baseline visit, the subject participated in another clinical study and used any exploratory drugs or devices; Allow participation in observational research;
• The researcher determines other situations that may affect the progress of clinical research and the determination of research results.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Yangkun Luo

CONTACT

13518161979; 621199521@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

CN (1)