UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055789 |
|---|---|
| Receipt number | R000063756 |
| Scientific Title | Prospective observational study for nausea and vomiting associated with CHOP or Pola-R-CHP therapy for malignant lymphoma |
| Date of disclosure of the study information | 2024/10/11 |
| Last modified on | 2025/10/10 18:10:13 |
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Basic information
Public title
Prospective observational study for nausea and vomiting associated with CHOP or Pola-R-CHP therapy for malignant lymphoma
Acronym
Prospective observational study for nausea and vomiting associated with CHOP or Pola-R-CHP therapy
Scientific Title
Prospective observational study for nausea and vomiting associated with CHOP or Pola-R-CHP therapy for malignant lymphoma
Scientific Title:Acronym
Prospective observational study for nausea and vomiting associated with CHOP or Pola-R-CHP therapy
Region
| Japan |
Condition
Condition
malignant lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the antiemetic effect of 5-HT3 receptor antagonist and corticosteroid combined with or without NK1 receptor antagonist for preventing nausea and vomiting induced by CHOP or Pola-R-CHP regimen
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response (CR) rate, defined as no emetic episodes and no use of rescue medication for overall phase (0-120hr) following the initiation of chemotherapy
Key secondary outcomes
1. CR rate during acute phase (0-24hr), delayed phase (24-120hr), overall delayed phase (24-168hr), beyond delayed phase (120-168hr) and overall period (0-168hr).
2. Total control (TC) rate (defined as no emetic episodes, no rescue medication, and no nausea) rate for the overall phase, delayed phase, overall delayed phase, beyond delayed phase and overall period (0-168hr)
3. Factors associated with CR and TC rates
4. Amount of food intake
5. Frequency of rescue medication
6. Time to treatment failure
7. Adverse event (PRO-CTCAE)
8. Satisfaction with antiemetic therapy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients (at least 20 and up to 75 years of age) with malignant lymphoma (non-Hodgkin lymphoma) receiving CHOP (cyclophosphamide: 750 mg/m2, doxorubicin: 50 mg/m2, vincristine: 1.4 mg/m2 (maximum 2 mg), prednisolone: 100 mg/day) or Pola-R-CHP (cyclophosphamide: 750 mg/m2, doxorubicin: 50 mg/m2, polatuzumab vedotin: 1.8 mg/kg, rituximab: 375 mg/m2) as first-line therapy
2. Eastern Cooperative Oncology Group performance status of 0-2
3. No symptomatic brain metastases
4. No ascites or pleural effusion requiring puncture therapy
5. No gastrointestinal obstruction such as gastropyloric stenosis or intestinal obstruction
6. No severe organ damage and meet the following criteria based on blood tests within 2 weeks prior to registration:
Alanine aminotransferase <100 IU/L
Aspartate aminotransferase <100 IU/L
Total bilirubin <2.0 mg/dL
Serum creatinine <1.5 mg/dL
7. Patients who can accurately document symptom diary
8. Patients who provided written informed consent
Key exclusion criteria
1. Patients with nausea and vomiting within 24-hours prior to initiation of chemotherapy
2. Patients receiving reduced doses of antineoplastic drugs
3. Patients receiving systemic steroids (except for use for disease control of the primary disease)
4. Patients regularly using antiemetic drugs other than 5-HT3 receptor antagonists and NK1 receptor antagonists
5. Patients receiving radiation therapy for the abdomen or pelvis within 1 week prior to initiation of chemotherapy
6. Started strong opioid analgesics within 48-hours before enrolment (dose modifications for drugs that have already been in use are permitted)
7. Patients deemed ineligible for the study by the investigator
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Miyoshi |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Pharmacy
Zip code
810-8563
Address
1-8-1, Jigyohama, Chuo-ku, Fukuoka
TEL
092-852-0700
miyoshi.takanori.jv@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Miyoshi |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Pharmacy
Zip code
810-8563
Address
1-8-1, Jigyohama, Chuo-ku, Fukuoka
TEL
092-852-0700
Homepage URL
miyoshi.takanori.jv@mail.hosp.go.jp
Sponsor or person
Institute
Kyushu National Hospital Organization Pharmacists Association
Institute
Department
Personal name
Funding Source
Organization
Kyushu National Hospital Organization Pharmacists Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of National Hospital Organization Kyushu Medical Center
Address
1-8-1, Jigyohama, Chuo-ku, Fukuoka
Tel
092-852-0700
602-rinri@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design
A prospective, observational, multicenter study
Patients
Patients with malignant lymphoma receiving CHOP or Pola-R-CHP as first-line therapy
Survey
1. Patient's background
2. Antiemetic therapy
3. Nausea, vomiting, Amount of food intake, rescue medications (from patient diary)
4. Adverse event (PRO-CTCAE)
5. Satisfaction with antiemetic therapy
Management information
Registered date
| 2024 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063756
