TumorPhase 2NCT04430361
the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
A Phase 2 study testing Megestrol, 5-HT3 receptor antagonist and dexamethasone in people with Tumor and Chemotherapy-induced Nausea and Vomiting, run by Henan Cancer Hospital at 1 site in China.
Trial summary
To compare the efficacy and safety of megestrol acetate dispersible tablets combined with 5-HT3 receptor antagonist and dexamethasone triple antiemetic regimen and 5-HT3 receptor antagonist and dexamethasone combined antiemetic regimen in the control of CINV induced by hyperemetic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumor, Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Megestrol, 5-HT3 receptor antagonist and dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2018to 30 May 2021
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Tumor patients diagnosed by histopathology or cytology, as long as the chemotherapy with cisplatin is used, the amount of cisplatin is 60-80 mg/m2;
- Unlimited gender, age 18 to 70 years old;
- ECOG physical status score 0-1;
- The survival time is predicted to be more than 3 months;
- Bone marrow hematopoietic function was not significantly impaired (WBC≥3.5109/L, ANC≥1.5109/L, PLT≥100109/L, Hb≥100g/L);
- Biochemical examination AST / ALT ≤ 2.5 times the upper limit of normal; bilirubin ≤ 1.5 times the upper limit of normal; creatinine clearance ≥ 60ml / min, normal ECG;
- Signing informed consent;
Who cannot join
- Women who are pregnant or breastfeeding, women of childbearing age who refuse to receive contraception;
- Brain metastasis;
- Combine all of the following serious or uncontrolled diseases that affect participation in the trial: Uncontrollable hypertension, history of unstable hypertension, or poor adherence to antihypertention drugs; Unstable angina; Symptomatic congestive heart failure; Myocardial infarction occurred within 6 months before enrollment; Severe uncontrollable arrhythmia; Uncontrollable diabetes; Active or uncontrollable infection; Intestinal paralysis, intestinal obstruction, interstitial pneumonia, active gastric ulcer; Subject to immunosuppressive therapy;
- Inability to understand or express informed consent;
- The investigator judged other conditions that were not suitable for clinical research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Ning Li, 13526501903, lining97@126.com
About this study
Official title: Comparison of the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: a Prospective, Randomized Controlled Phase II Clinical Trial
To compare the efficacy and safety of megestrol acetate dispersible tablets combined with 5-HT3 receptor antagonist and dexamethasone triple antiemetic regimen and 5-HT3 receptor antagonist and dexamethasone combined antiemetic regimen in the control of CINV induced by hyperemetic chemotherapy.
Read the detailed description
120 patients with malignant tumors diagnosed by pathology or cytology and treated with highly emetogenic chemotherapy drugs containing cisplatin from September 2018 to December 2019 were selected. The patients were randomly assigned to megestrol group (megestrol acetate dispersible tablets+5-HT3 receptor antagonist+dexamethasone) or control group (5-HT3 receptor antagonist + dexamethasone) at 1:1. The dosage of antiemetic drugs in the control group: 5-HT3 receptor antagonist 2.5mg, dexamethasone 12mg on the first day, 8mg on the 2nd-4th day, all were injected intravenously with 30min before chemotherapy for 5 days. The patients in the megestrol acetate group were given megestrol acetate dispersible tablets on the basis of the control group. 160 mg of megestrol acetate dispersible tablets were taken orally every morning on the day of the beginning of chemotherapy for 10 days. The main end point was the proportion of control of nausea and vomiting between the two groups during the delayed period (24-120 hours after the beginning of chemotherapy), that is, the proportion of complete remission (no vomiting and no need for rescue treatment) and complete prevention (no nausea and vomiting).The secondary end point was the control ratio of nausea and vomiting in the acute phase (0-24 hours after the beginning of chemotherapy) and the overall phase (0-120 hours after the beginning of chemotherapy); the proportion of patients with grade 3-4 nausea and vomiting during chemotherapy; the adverse reactions related to antiemetic drugs and the score of quality of life of patients in both groups before and after treatment.
- Conditions
- Tumor, Chemotherapy-induced Nausea and Vomiting
- Being tested
- Megestrol, 5-HT3 receptor antagonist, dexamethasone
- Keywords
- Megestrol, Tumor, Cisplatin, Chemotherapy-induced nausea and vomiting, Highly emetogenic chemotherapy
- Medical subject headings
- Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MegestrolDrug
Also called Megestrol acetate
160 mg of megestrol acetate dispersible tablets were taken orally every morning on the day of the beginning of chemotherapy for 10 days.
5-HT3 receptor antagonistDrug
5-HT3 receptor antagonist 2.5mg/iv
dexamethasoneDrug
dexamethasone 12mg on the first day, 8mg on the 2nd-4th day,
| Study group | Role | What they receive |
|---|---|---|
| Megestrol | Experimental | Palonosetron 2.5mg, Dexamethasone 12mg on the first day, 8mg on the 2nd-4th day, Megestrol acetates 160mg orally every morning on the day of the beginning of chemotherapy for 10 days. Receives: Drug: Megestrol; Drug: 5-HT3 receptor antagonist; Drug: dexamethasone |
| Control | Other | Palonosetron 2.5mg, Dexamethasone12mg on the first day, 8mg on the 2nd-4th day Receives: Drug: 5-HT3 receptor antagonist; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of control of nausea and vomiting between the two groups during the delayed period
The main end point was the proportion of control of nausea and vomiting between the two groups during the delayed period chemotherapy
Measured: 24 to120 hours
Secondary outcomes (4)
The control ratio of nausea and vomiting in the acute phase and the overall phase
The control ratio of nausea and vomiting in the acute phase and the overall phase
Measured: 0 to 120 hours
The proportion of patients with grade 3-4 vomiting
The proportion of patients with grade 3-4 vomiting during chemotherapy
Measured: 0 to 120 hours
The adverse reactions related to antiemetic drugs
The adverse reactions related to antiemetic drugs of patients in both groups before and after treatment.
Measured: 1 mounth
The score of quality of life of patients
The score of quality of life of patients in both groups before and after treatment.
Measured: 1 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start7 Sep 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Suxia Luo, Principal investigator, Henan Cancer HospitalNing Li, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430361
- Sponsor's protocol ID
- 2017098
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: a Prospective, Randomized Controlled Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04430361
- Acronym / sponsor ID
- 2017098
- Conditions
- Tumor, Chemotherapy-induced Nausea and Vomiting
- Keywords
- Megestrol, Tumor, Cisplatin, Chemotherapy-induced nausea and vomiting, Highly emetogenic chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy and safety of megestrol acetate dispersible tablets combined with 5-HT3 receptor antagonist and dexamethasone triple antiemetic regimen and 5-HT3 receptor antagonist and dexamethasone combined antiemetic regimen in the control of CINV induced by hyperemetic chemotherapy.
Detailed description
120 patients with malignant tumors diagnosed by pathology or cytology and treated with highly emetogenic chemotherapy drugs containing cisplatin from September 2018 to December 2019 were selected. The patients were randomly assigned to megestrol group (megestrol acetate dispersible tablets+5-HT3 receptor antagonist+dexamethasone) or control group (5-HT3 receptor antagonist + dexamethasone) at 1:1. The dosage of antiemetic drugs in the control group: 5-HT3 receptor antagonist 2.5mg, dexamethasone 12mg on the first day, 8mg on the 2nd-4th day, all were injected intravenously with 30min before chemotherapy for 5 days. The patients in the megestrol acetate group were given megestrol acetate dispersible tablets on the basis of the control group. 160 mg of megestrol acetate dispersible tablets were taken orally every morning on the day of the beginning of chemotherapy for 10 days. The main end point was the proportion of control of nausea and vomiting between the two groups during the delayed period (24-120 hours after the beginning of chemotherapy), that is, the proportion of complete remission (no vomiting and no need for rescue treatment) and complete prevention (no nausea and vomiting).The secondary end point was the control ratio of nausea and vomiting in the acute phase (0-24 hours after the beginning of chemotherapy) and the overall phase (0-120 hours after the beginning of chemotherapy); the proportion of patients with grade 3-4 nausea and vomiting during chemotherapy; the adverse reactions related to antiemetic drugs and the score of quality of life of patients in both groups before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Megestrol | Experimental | Drug: Megestrol, Drug: 5-HT3 receptor antagonist, Drug: dexamethasonePalonosetron 2.5mg, Dexamethasone 12mg on the first day, 8mg on the 2nd-4th day, Megestrol acetates 160mg orally every morning on the day of the beginning of chemotherapy for 10 days. |
| Control | Other | Drug: 5-HT3 receptor antagonist, Drug: dexamethasonePalonosetron 2.5mg, Dexamethasone12mg on the first day, 8mg on the 2nd-4th day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Tumor patients diagnosed by histopathology or cytology, as long as the chemotherapy with cisplatin is used, the amount of cisplatin is 60-80 mg/m2;
- Unlimited gender, age 18 to 70 years old;
- ECOG physical status score 0-1;
- The survival time is predicted to be more than 3 months;
- Bone marrow hematopoietic function was not significantly impaired (WBC≥3.5109/L, ANC≥1.5109/L, PLT≥100109/L, Hb≥100g/L);
Key exclusion criteria (5 listed)
- Women who are pregnant or breastfeeding, women of childbearing age who refuse to receive contraception;
- Brain metastasis;
- Combine all of the following serious or uncontrolled diseases that affect participation in the trial: Uncontrollable hypertension, history of unstable hypertension, or poor adherence to antihypertention drugs; Unstable angina; Symptomatic congestive heart failure; Myocardial infarction occurred within 6 months before enrollment; Severe uncontrollable arrhythmia; Uncontrollable diabetes; Active or uncontrollable infection; Intestinal paralysis, intestinal obstruction, interstitial pneumonia, active gastric ulcer; Subject to immunosuppressive therapy;
- Inability to understand or express informed consent;
- The investigator judged other conditions that were not suitable for clinical research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MegestrolAlso: Megestrol acetate160 mg of megestrol acetate dispersible tablets were taken orally every morning on the day of the beginning of chemotherapy for 10 days. | Drug | Megestrol |
| 5-HT3 receptor antagonist5-HT3 receptor antagonist 2.5mg/iv | Drug | Control, Megestrol |
| dexamethasonedexamethasone 12mg on the first day, 8mg on the 2nd-4th day, | Drug | Control, Megestrol |
Primary outcome
The proportion of control of nausea and vomiting between the two groups during the delayed period
Time frame: 24 to120 hours
The main end point was the proportion of control of nausea and vomiting between the two groups during the delayed period chemotherapy
4 secondary outcomes
The control ratio of nausea and vomiting in the acute phase and the overall phase
Time frame: 0 to 120 hours
The proportion of patients with grade 3-4 vomiting
Time frame: 0 to 120 hours
The adverse reactions related to antiemetic drugs
Time frame: 1 mounth
The score of quality of life of patients
Time frame: 1 mounth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suxia Luo principal investigator
Henan Cancer Hospital
Ning Li principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Megestrol, 5-HT3 receptor antagonist and dexamethasone in people with Tumor and Chemotherapy-induced Nausea and Vomiting, run by Henan Cancer 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 7 inclusion and 5 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 12 Jun 2020. 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 Ning Li (13526501903, lining97@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of control of nausea and vomiting between the two groups during the delayed period (time frame: 24 to120 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2020.