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Gastrointestinal NeoplasmsPhase 3CINVNCT03674294

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

A Phase 3 study testing Aprepitant, Palonosetron and Dexamethasone in people with Gastrointestinal Neoplasms and Chemotherapy-induced Nausea and Vomiting, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
Aprepitant, Palonosetron and Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
1 siteChina
Study dates
4 Aug 2015to 1 Jun 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Efficacy of Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Nondrinking Women Younger Than 50 Years Who Received Moderately Emetogenic Chemotherapy: A Randomized, Double-blind, Phase Ⅲ Trial

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.

Read the 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 chemotherapy.

Being tested
Aprepitant, Palonosetron, Dexamethasone, Placebo Oral Tablet
Medical subject headings
Gastrointestinal Neoplasms, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AprepitantDrug

    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

  • PalonosetronDrug

    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.

  • DexamethasoneDrug

    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 Oral TabletDrug

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

Study groups in NCT03674294
Study groupRoleWhat they receive
Palonosetron/Dexamethasone/AprepitantExperimentalNot described
Receives: Drug: Aprepitant; Drug: Palonosetron; Drug: Dexamethasone
Palonosetron/Dexamethasone/PlaceboPlacebo comparatorNot described
Receives: Drug: Palonosetron; Drug: Dexamethasone; Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to 1-2 months

Secondary outcomes (5)

  1. Complete response rate in the acute phase

    The proportion of patients without emesis episodes or rescue medication use during the acute phase (0-24h)

    Measured: Up to 1-2 months

  2. Complete response rate in the delayed phase

    The proportion of patients without emesis episodes or rescue medication use during the delayed phase (25-120 h)

    Measured: Up to 1-2 months

  3. No vomiting rate in the acute phase, delayed phase and overall phase

    The proportion of no vomiting (no vomiting or retching episodes) in the acute phase, delayed phase and overall phase

    Measured: Up to 1-2 months

  4. Affection caused by CINV reported by patients

    Measured: Up to 1-2 months

  5. Effects of CINV on daily life

    Measured: Up to 1-2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2018
  2. Study start4 Aug 2015
  3. Primary completion31 Mar 2020
  4. Study completion1 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03674294
Sponsor's protocol ID
Aprepitant-CINV
Acronym
CINV
Status last verified
Feb 2023
First submitted
18 Apr 2018
Last updated
8 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 33835174

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aprepitant, Palonosetron and Dexamethasone in people with Gastrointestinal Neoplasms and Chemotherapy-induced Nausea and Vomiting, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate during the overall phase (time frame: Up to 1-2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03674294, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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