Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC

NCT03572829 | Completed Phase 2 DMC

• 1 other identifier: CH-RCS-004
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of aprepitant combined with ondansetron and dexamethasone to prevent nausea and vomiting induced by Intensity-modulated Radiotherapy (IMRT) cisplatin-chemotherapy regimen in locally advanced squamous cell carcinoma of head and neck

Conditions

Vomiting; Nausea Post Chemotherapy; Head Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  no vomiting and nausea, and no use of rescue therapy

  up to 8 weeks

Secondary Outcomes (3)

• Complete response rate

  up to 3 weeks

• Complete response rate

  up to 6 weeks

• European Organization for Research on Treatment of Cancer Quality of life questionnaire

  up to 12 weeks

Study Arms (1)

Aprepitant

EXPERIMENTAL

Aprepitant combined with ondansetron and dexamethasone

Drug: Aprepitant

Interventions

Aprepitant 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. Patients receive concurrent aprepitant 125mg, dexamethasone 12mg, and ondansetron 8mg p.o. on day1. AND then patients received aprepitant 80mg, dexamethasone 8mg on day 2-5 at every chemotherapy cycle.

Also known as: Dexamethasone, Ondansetron

Aprepitant

Eligibility Criteria

• Age: 18 Years - 80 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:

• Nausea and vomiting occurred 24 hours before the start of the chemotherapy; Corticosteroid or benzodiazepines used; Combination Medicine which metabolism through drug-metabolizing enzyme CPY3A4 and CYP2D6; Serious cardiovascular, pulmonary, diabetes, mental and other diseases; Perinatal women or refused to take contraception during treatment; Other induced vomiting factors. (The transfer of the central nervous system, intestinal obstruction or hypocalcemia, and so on)

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/ Cancer Hospital, Chinese Academy of Medcal science and Peking Union Medical College

Beijing, China

Location

MeSH Terms

Conditions

Vomiting; Head and Neck Neoplasms

Interventions

Aprepitant; Dexamethasone; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Junlin Yi, M.D.

  National Cancer Center/ Cancer Hospital, Chinese Academy of Medcal science and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

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: Vice director of department of radiation oncology

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 28, 2018
• Study Start: March 1, 2018
• Primary Completion: January 9, 2020
• Study Completion: July 1, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)