AzTrials
AzTrials

Chemotherapy-induced Nausea and VomitingPhase 2NCT05325190

Granisetron Transdermal Patch System for Prevention of CINV by CapeOX

A Phase 2 study testing Granisetron Transdermal Patch System in people with Chemotherapy-induced Nausea and Vomiting, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study aims to explore the prevention of delayed chemotherapy induced by CAPOX regimen with granisetron transdermal patch。 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy-induced Nausea and Vomiting
What is being tested?
Granisetron Transdermal Patch System
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteChina
Study dates
10 Oct 2021to 1 Jun 2023
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged >18 years.
  • Eligible patients were diagnosed with a colorectal malignancy and scheduled to receive chemotherapy of CapeOx regimens.
  • The Eastern Cooperative Oncology Group Performance Status (ECOG PS) scores of patients were between 0 and 2.
  • Patients with life expectancy≥6 months.
  • Patients with the ability to understand the study and are willing to sign written informed consent document.
  • Patients who were able to read, understand and follow the study procedures，and completed the questionnaire unaided.

Who cannot join

  • Patients with metabolic and haematological abnormalities who are unsuitable for chemotherapy. The following criteria are included: (1) Abnormal of blood routine: absolute neutrophil count(ANC) <1.5*109/L，white blood cell count (WBC)<3.0*109/L, platelet count (PLT) <100*109/L or hemoglobin (HB)<100g/L;(2) Abnormal liver function: aspartate aminotransaminase (AST) and/or aspartate aminotransferase (ALT)≥2.5*ULN, bilirubin is greater than 1.5 times the upper limit of normal value (ULN). In patients with known liver metastasis: AST is greater than or equal to 5 times the upper limit of normal value (ULN); ALT is greater than or equal to 5 times the upper normal value (ULN); (3) Abnormal renal function: serum creatinine is greater than 1.5*ULN.
  • Patient had symptomatic primary or metastatic central nervous system malignancies.
  • Patient used any drug with potential antiemetic effect within 7 days before receiving chemotherapy: 5-HT3 receptor antagonist (such as granisetron), phenothiazide (such as chlorpromazine), phenylbutanone (such as haloperidol), benzamide (such as metoclopramide), domperidone, cannabinoids, herbal medicine with potential antiemetic effect, anisodamine, seclizine, etc.
  • Patients began to receive benzodiazepines or opioids within 48 hours before the first day of the study (except for single daily use of triazolam, temazepam or midazolam).
  • Patients shall not receive any dose of systemic glucocorticoid treatment within 72 hours before the first day, except as specified in the protocol.
  • Patients with historical or predisposing cardiac conduction abnormalities (such as torsade de pointe, ventricular tachycardia, long QT interval syndrome, or others), excluding incomplete right bundle branch block.
Show all 13Show fewer
  • Patients with severe cardiovascular diseases include acute myocardial infarction, unstable angina pectoris, significant membranous or pericardial disease, history of ventricular tachycardia, symptomatic chronic heart failure (New York Heart Association [NYHA] class III-IV) and uncontrolled hypertension.
  • Patients with severe emotional or mental disorders.
  • Patients are taking or has used the following CYP3A4 inducers within 30 days before the first day of treatment, which will affect the efficacy of therapeutic drugs according to the evaluation of the researcher.
  • Patients are taking or has used the following CYP3A4 substrates and inhibitors within 7 days before the first day of treatment, which will significantly increase the adverse events related to therapeutic drugs according to the evaluation of the investigator.
  • Patients with active phase infection (e.g. pneumonia) or any uncontrolled disease (such as diabetic ketoacidosis or gastrointestinal obstruction), researchers believe that treatment may confuse research results or lead to uncertainty risk.
  • Pregnant women, lactating women, or women of childbearing age with positive blood and/or urine HCG test results before the test. Male and female subjects did not take effective contraceptive measures, or planned to be pregnant within 6 months after the start of the trial.
  • Patients have any medical history that the investigator believes may confound the results of the study or expose the patient to unnecessary risks.

Trial locations and contacts

1 site in 1 country.

Cong Wang, Doctor contact

+86 13752570372

wangcongalex@126.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

    Wang Cong, Master, 86-13752570372, wangcongalex@126.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Granisetron Transdermal Patch System for Prevention of Chemotherapy-induced Delayed Nausea and Vomiting by CapeOX：A Single-Arm, Open-Label, Phase II Study.

This study aims to explore the prevention of delayed chemotherapy induced by CAPOX regimen with granisetron transdermal patch。

Read the detailed description

Chemotherapy induced nausea and vomiting (CINV) is one of the most common side effects of tumor chemotherapy. Anorexia occurs in mild cases, electrolyte and acid-base balance disorders and malnutrition even occur in severe cases. Some patients will also have anxiety, fear and depression, which seriously affect the quality of life. This study explored the efficacy and safety of granisetron transdermal patch in the prevention of delayed nausea and vomiting caused by capeox chemotherapy.

Being tested
Granisetron Transdermal Patch System
Medical subject headings
Vomiting

What participants receive

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

  • Granisetron Transdermal Patch SystemDrug

    Also called Sancuso®

    Granisetron transdermal patch 3.1mg was given 48 hours before the first day of chemotherapy, Dexamethasone 12mg was taken orally on the first day of chemotherapy and dexamethasone 8mg was taken orally on the second and third days of chemotherapy,3.1mg granisetron transdermal patch was replaced on the 5th day of chemotherapy. Granisetron transdermal patch was removed and discarded on the 12th day of chemotherapy.

Study groups in NCT05325190
Study groupRoleWhat they receive
Intervention groupExperimentalGranisetron transdermal patch 3.1mg was given 48 hours before the first day of chemotherapy, Dexamethasone 12mg was taken orally on the first day of chemotherapy and dexamethasone 8mg was taken orally on the second and third days of chemotherapy,3.1mg granisetron transdermal patch was replaced on the 5th day of chemotherapy. Granisetron transdermal patch was removed and discarded on the 12th day of chemotherapy.
Receives: Drug: Granisetron Transdermal Patch System

What is being measured

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

  1. Complete control rate of delayed nausea and vomiting

    Complete control rate of delayed nausea and vomiting (CC, 24 hours to 20 days before the first day of chemotherapy)

    Measured: 24 hours to 20 days before the first day of chemotherapy

Secondary outcomes (5)

  1. Dates of delayed complete control

    Definition of DDCC (dates of delayed complete control): from 24 hours to the 20th day of chemotherapy, the patient has no vomiting, no rescue treatment, no nausea (VAS < 5mm) or mild nausea (VAS < 25mm, mild);

    Measured: from 24 hours to the 20th day of chemotherapy

  2. Complete control rate of acute nausea and vomiting

    From 0 hour to 24 hours after chemotherapy, the patients did not vomit or need rescue treatment, and there was no incidence of nausea (VAS < 5mm) or mild nausea (VAS < 25mm).

    Measured: 24 hours to 20 days before the first day of chemotherapy

  3. Proportion of subjects receiving remedial treatment

    The investigator evaluated the degree of nausea and vomiting reported by the patient and the observed clinical manifestations according to the study

    In the judgment of the patient, remedial treatment can be used only when necessary to treat nausea or vomiting, and remedial treatment shall not be used when the patient does not have such symptoms.

    Measured: 24 hours to 20 days before the first day of chemotherapy

  4. Changes of FLIE score before and after treatment

    FLIE includes 9 questions about nausea and 9 questions about vomiting. The answers to each item were marked according to the visual analog scale with a score of 7. The nausea score, vomiting score and total score were calculated by summing the answers of each category and the total answer. Considering the purpose of this scheme, "no impact" on daily life is defined as that the average item score is greater than 6 points (total score > 108) according to 7 subscales.

    Measured: 24 hours to 20 days before the first day of chemotherapy

  5. Changes of hospital anxiety and Depression Scale (HAD) scores before and after treatment

    HAD is mainly used for screening anxiety and depression of patients in general hospitals. There are 14 items in this scale, including 7

    Depression was assessed in items (21 points in total), and anxiety was assessed in 7 items (21 points in total). The score of depression subscale is 0-7, indicating no symptoms; 8-10 points are suspicious of depressive symptoms, and 11-21 points must have depressive state. Anxiety subscale score 0-7

    Asymptomatic; The anxiety symptoms are suspicious on 8-10 points, and there must be anxiety on 11-21 points.

    Measured: 24 hours to 20 days before the first day of chemotherapy

Timeline

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

  1. First posted13 Apr 2022
  2. Study start10 Oct 2021
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion1 Jun 2023 (estimated)

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Granisetron transdermal patch for the prevention and treatment of CINV
Masking
None (open label)
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05325190
Sponsor's protocol ID
E20210665A
Status last verified
Mar 2022
First submitted
27 Mar 2022
Last updated
13 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang C, Jiang Z, Zhang J, Zhuang Y, Sun L, Zhang J, Quan M, Lan L, Li Y, Wang B, Pan Z, Yan Z. Prolonged administration of the granisetron transdermal delivery system reduces capecitabine plus oxaliplatin regimen induced nausea and vomiting. BMC Cancer. 2024 Jul 18;24(1):867. doi: 10.1186/s12885-024-12616-9.

    PubMed 39026165

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Granisetron Transdermal Patch System in people with Chemotherapy-induced Nausea and Vomiting, run by Tianjin Medical University Cancer Institute and Hospital 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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Cong Wang, Doctor (+86 13752570372, wangcongalex@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete control rate of delayed nausea and vomiting (time frame: 24 hours to 20 days before the first day of chemotherapy). 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 NCT05325190, 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 13 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in