Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aprepitant Triple Therapy Caused Chemotherapy Induced Nausea And Vomiting In Gastrointestinal Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03674294
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yuhong Li, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Colo-rectal Cancer Chemotherapy-induced Neutropenia Drug: Aprepitant Drug: Palonosetron Drug: Dexamethasone Drug: Placebo Oral Tablet Phase 2

Detailed Description:
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 after curative effect among gastrointestinal malignancy patients with high risk factors of chemotherapy-associated adverse events.This study will observe and evaluate the incidence and severity of nausea and vomiting as well as the effectiveness of corresponding treatment(with or without Aprepitant) during Day 1 to Day 5 from the beginning of chemotheray.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sun Yat-sen University Cancer Center
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : December 29, 2019
Estimated Study Completion Date : December 29, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aprepitant

Arm Intervention/treatment
Experimental: Palonosetron/Dexamethasone/Aprepitant Drug: Aprepitant
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

Drug: Palonosetron
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.

Drug: Dexamethasone
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.

Placebo Comparator: Palonosetron/Dexamethasone/Placebo Drug: Palonosetron
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.

Drug: Dexamethasone
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.

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




Primary Outcome Measures :
  1. Complete remission rates during observation [ Time Frame: Up to 1-2 months ]

Secondary Outcome Measures :
  1. Complete remission rates of acute stage [ Time Frame: Up to 1-2 months ]
    Total observation period of vomiting

  2. Complete remission rates of lag stage [ Time Frame: Up to 1-2 months ]
  3. No vomiting during observation [ Time Frame: Up to 1-2 months ]
  4. Affection caused by CINV reported by patients [ Time Frame: Up to 1-2 months ]
  5. Duration to the first time of vomiting. [ Time Frame: Up to 1-2 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed by pathology as gastrointestinal carcinoma and no previous FOLFOX or FOLFIRI based regimen chemotherapy history.
  • Female.
  • Adult patients ( ≥ 18, ≤ 75 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 question.
  • Before subject registration, written informed consent must be given according to local regulations.

Exclusion Criteria:

  • 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 unsuitted to the trial.
  • Unable or unwilling to follow research programme.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674294


Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Yuhong, MD    020-87342487    liyh@sysucc.org.cn   
Principal Investigator: Li Yuhong, MD         
Sponsors and Collaborators
Sun Yat-sen University

Layout table for additonal information
Responsible Party: Yuhong Li, Director, Department of Medical Oncology, Principal Investigator, Clinical Professor, Yuhong Li, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03674294     History of Changes
Other Study ID Numbers: Aprepitant-CINV
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Neutropenia
Colorectal Neoplasms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Dexamethasone
Dexamethasone acetate
Aprepitant
Fosaprepitant
Palonosetron
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones