Aprepitant Triple Therapy for the Prevention of CINV in Nondrinking and Young Women Who Received Moderately Emetogenic Chemotherapy

NCT03674294 | Completed Phase 3

• 1 other identifier: Aprepitant-CINV
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study whether adding Aprepitant to Palonosetron and dexamethasone can further prevent the incidence and severity of nausea and vomiting caused by FOLFIRI or FOLFOX chemotherapy regimen among gastrointestinal malignancy patients with high risk factors of chemotherapy-associated adverse events.

Conditions

Gastrointestinal Neoplasms; Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Complete response rate during the overall phase

  The proportion of patients without emesis episodes or rescue medication use during the overall phase (0-120 h)

  Up to 1-2 months

Secondary Outcomes (5)

• Complete response rate in the acute phase

  Up to 1-2 months

• Complete response rate in the delayed phase

  Up to 1-2 months

• No vomiting rate in the acute phase, delayed phase and overall phase

  Up to 1-2 months

• Affection caused by CINV reported by patients

  Up to 1-2 months

• Effects of CINV on daily life

  Up to 1-2 months

Study Arms (2)

Palonosetron/Dexamethasone/Aprepitant

EXPERIMENTAL

Drug: Aprepitant; Drug: Palonosetron; Drug: Dexamethasone

Palonosetron/Dexamethasone/Placebo

PLACEBO COMPARATOR

Drug: Palonosetron; Drug: Dexamethasone; Drug: Placebo Oral Tablet

Interventions

Aprepitant DRUG

Aprepitant is manufactured by Merck \& Co. for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) and for prevention of postoperative nausea and vomiting. It was approved by the FDA in 2003

Palonosetron/Dexamethasone/Aprepitant

Palonosetron DRUG

Palonosetron is a 5-HT3 antagonist used in the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). It is used for the control of delayed CINV-nausea and vomiting and there are tentative data to suggest that it may be more effective than granisetron.

Palonosetron/Dexamethasone/Aprepitant; Palonosetron/Dexamethasone/Placebo

Dexamethasone DRUG

Dexamethasone is a type of corticosteroid medication. It is used in the treatment of many conditions, including rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive lung disease, croup, brain swelling, and along with antibiotics in tuberculosis.

Palonosetron/Dexamethasone/Aprepitant; Palonosetron/Dexamethasone/Placebo

Placebo Oral Tablet DRUG

In the current clinical trial, placebo oral tablet is provided as a substance for Aprepitant with no active therapeutic effect.

Palonosetron/Dexamethasone/Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed by pathology as gastrointestinal carcinoma and no previous FOLFOX or FOLFIRI based regimen chemotherapy history.
• Female.
• Adult patients ( ≥ 18, ≤ 50 years of age)
• No long-term or excessive alcohol intake history:1.Alcohol intake less than 5 times per week; 2.Alcohol intake less than 100g per day.
• Performance status ECOG 0-1
• Adequate haematological, hepatic, renal and metabolic function parameters:
• Leukocytes : 3,500-10,000/mm3, ANC ≥ 1,500/mm3, Platelets ≥ 90,000/mm3, Hb \> 9g/dl (may be transfused or treated with erythropoietin to maintain or exceed this level), Serum creatinine ≤ 1 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal, Serum AST, ALT, ALP ≤ 2.5 x upper limit of normal in absence of liver metastases, or ≤ 5 x upper limit of normal in presence of liver metastases.
• Negative pregnancy test. If pregnancy test were positive, subject should be included in the trial only when the subsequent pregnancy test is negative.
• Ability of reading, comprehending and finishing trial questionnaires and record, including VAS (Visual Analogue Scale) question.
• Before subject registration, written informed consent must be given according to local regulations.

You may not qualify if:

• Pregnant women without morning sickness.
• Presence of gastrointestinal tract obstruction or electrolyte imbalance.
• Any history of central nervous system disease(e.g. Primary brain tumour, seizure not controlled with standard medical therapy, brain metastases or history of stroke).
• Contraindication of glucocorticoid:1.Infection of virus, bacteria or fungus uncontrolled by antibiotics; 2.Active stomach or duodenum ulcer; 3.Severe hypertension, atherosclerosis, diabetes; 4.Osteoporosis;5.Corneal ulcer; 6.Pregnancy; 7.Reparative phase of trauma, operation or fraction; 8.Hypercortisolism; 9.Severe mental disorder or epilepsy; 10.Inadequate cardiac or renal function.
• Mental disability or severe emotional or mental disorder.
• Active infection(e.g. pneumonia, hepatitis) or any uncontrolled disease(e.g.diabetic ketoacidosis) that may affect study outcome or expose patients to unnecessary risk.
• Usage of any illicit drug, including medical marijuana or alcohol abusing(China drug dependence criteria).
• Treatment of unapproved medicine in the previous 4 weeks.
• Concomitant therapy of psychotropic medicine such as olanzapine.
• Hypersensitivity history towards Aprepitant, 5-HT3 receptor antagonist or dexamethasone.
• Previous treatment of Aprepitant.
• Unable to swallow capsules.
• Main researchers considered that the patient is unsuited to the trial.
• Unable or unwilling to follow research programme.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Wang DS, Hu MT, Wang ZQ, Ren C, Qiu MZ, Luo HY, Jin Y, Fong WP, Wang SB, Peng JW, Zou QF, Tan Q, Wang FH, Li YH. Effect of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Women: A Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e215250. doi: 10.1001/jamanetworkopen.2021.5250.

  PMID: 33835174 DERIVED

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Vomiting

Interventions

Aprepitant; Palonosetron; Dexamethasone

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Medical Oncology, Principal Investigator, Clinical Professor, Yuhong Li

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: September 17, 2018
• Study Start: August 4, 2015
• Primary Completion: March 31, 2020
• Study Completion: June 1, 2020
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)