The Optimization of Antiemetic Regimen for C-RINV in LA-HNSCCs

NCT05202275 | Unknown Phase 2 DMC

• 1 other identifier: LC2020A16
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study sought to investigate the efficacy and safety of a three-drug combination antiemetic regimen of olanzapine combined with aprepitant and palonosetron for the prevention of chemoradiotherapy-induced nausea and vomiting in locally advanced head and neck squamous cell carcinoma.

Conditions

Nausea; Vomiting; Head and Neck Squamous Cell Carcinoma; Radiotherapy Side Effect

Keywords

Chemoradiotherapy; nausea; vomiting; Antiemetic regimen

Outcome Measures

Primary Outcomes (1)

• Nausea-free response rate

  The percentage of patients with no nausea (Visual Analogue Scale score 0) during concurrent chemotherapy.

  Up to 6.5 weeks

Secondary Outcomes (4)

• Emesis-free response rate

  Up to 6.5 weeks

• Complete response rate

  Up to 6.5 weeks

• Complete protection rate

  Up to 6.5 weeks

• The rate of no significant nausea

  Up to 6.5 weeks

Study Arms (1)

OPA regimen

EXPERIMENTAL

All patients were given orally olanzapine 10mg once on d1-5; intravenously palonosetron 0.25mg once on d1; aprepitant 125 mg once on d1, then 80mg once on d2-5.

Drug: Olanzapine

Interventions

Olanzapine DRUG

Intensity-modulated radiotherapy was given to the patients with regimen of 69.96 Gy-73.92 Gy to the gross target volume of nasopharynx, 69.96 Gy to the gross target volume of positive nodes, 60.06 Gy the high risk clinical target volume, 50.96 Gy to the low risk clinical target volume. Concurrent chemotherapy is administrated with cisplatin 100mg/m2 at d1, d22, d43 during radiotherapy. All patients were given orally olanzapine 10mg once on d1-5; intravenously palonosetron 0.25mg once on d1; aprepitant 125 mg once on d1, then 80mg once on d2-5 at every chemotherapy cycle.

Also known as: Palonosetron, Aprepitant

OPA regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathology confirmed squamous cell carcinoma. The primary sites included nasopharynx, mouth, oropharynx, hypopharynx, larynx, nasal cavity and paranasal sinuses Aged 18 to 70 years old Stage III-IVB diseases Eastern Cooperative Oncology Group Performance Status 0-1 Normally functioning of liver, kidney, bone marrow Concurrent chemoradiotherapy is recommended after multi-disciplinary team discussion; Must be able to swallow tablets At least 12 weeks lifetime was expected; Fertile male or female patients volunteered to use effective contraception within 90 days of the study period and at the end of study.

You may not qualify if:

• Other medical histories of malignancy apart from non-melanoma skin cancer, cervical carcinoma in situ, and early-stage cured prostate cancer Nausea and emesis occurred 24 hours before the start of CCRT Any medicine which affected metabolism through drug-metabolising enzymes CPY3A4 and CYP2D6 except for nighttime sedatives Mental and severe cognitive impairment Perinatal women or rejection of taking contraception during treatment Drug and/or alcohol addiction Symptomatic brain metastasis Gastrointestinal obstruction Hypocalcemia or any other conditions that could provoke emesis Treatment with another antipsychotic agent for 30 days before or during protocol therapy Concurrent chest or abdominal radiotherapy Concurrent use of corticosteroid or amifostine or quinolone antibiotic therapy Known hypersensitivity to olanzapine Known uncontrolled cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months Medical history of diabetic ketoacidosis or uncontrolled diabetes mellitus, prostate enlargement, narrow angle glaucoma

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Ye Zhang

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting; Squamous Cell Carcinoma of Head and Neck; Radiation Injuries

Interventions

Olanzapine; Palonosetron; Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ye Zhang, MD

  National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zekun Wang, MD

CONTACT

+8618710221130; dr_wangzk@163.com

Ye Zhang, MD

CONTACT

+8613717635880; drzye1983@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 21, 2022
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: September 1, 2023
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

CN (1)