UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052758 |
|---|---|
| Receipt number | R000060201 |
| Scientific Title | The Effects of Ginger Extract Beverage on Nausea, Vomiting, and Nutritional Status in Chemotherapy-treated Cancer Patients |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2023/11/10 15:59:50 |
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Basic information
Public title
The Effects of Ginger Extract Beverage on Nausea, Vomiting, and Nutritional Status in Chemotherapy-treated Cancer Patients
Acronym
Nutritional Supplements for Prevention of Nausea and Vomiting
Scientific Title
The Effects of Ginger Extract Beverage on Nausea, Vomiting, and Nutritional Status in Chemotherapy-treated Cancer Patients
Scientific Title:Acronym
Study of Nutraceutical Beverage with Ginger Extract for Prevention of Nausea and Vomiting
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects on nausea and vomiting in hospitalized lung cancer patients who consume a dietary supplement drink (Isocal Clear) containing ginger extract from 3 days before to 7 days after chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Complete response (CR)
*CR is defined as nausea of 0 at NRS, no emetic events, and no emergency antiemetic use.
Key secondary outcomes
1) Nausea
2) Vomiting event
3) Urgent use of antiemetic drugs
4) Weight change
5) Compliance with intake (intervention group only)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with head and neck cancer, gynecological cancer, and lung cancer eligible for NST intervention who are hospitalized in our hospital
2) Patients 20 years of age or older
3) Patients who have undergone chemotherapy for cancer within 1 month prior to obtaining consent and have CTCAEv4.0-JCOG Grade 2 or higher nausea (marked weight loss, dehydration or decreased oral intake without malnutrition)
4) Patients scheduled to receive chemotherapy during hospitalization
(5) Patients who are able to eat and drink orally.
6) Patients who are able to obtain written consent.
Key exclusion criteria
(1) Patients whose chemotherapy within 1 month prior to obtaining consent and whose planned chemotherapy is expected to change
(2) Patients who are expected to change their chemotherapy antiemetic regimen within 1 month prior to obtaining consent and their scheduled chemotherapy antiemetic regimen.
(3) Patients who are deemed inappropriate as research subjects by the Principal Investigator and the Principal Investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sakaue |
Organization
Tokushima University Graduate School
Division name
Department of Nutrition and Metabolism, Institute of Biomedical sciences
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima 770-8503
TEL
0886339249
hsakaue@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiorhshi |
| Middle name | |
| Last name | Sakaue |
Organization
Tokushima University Graduate School
Division name
Department of Nutrition and Metabolism, Institute of Biomedical sciences
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima 770-8503
TEL
0886339249
Homepage URL
hsakaue@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Nutrition and Metabolism, Institute of Biomedical sciences
Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Department of Nutrition and Metabolism, Institute of Biomedical sciences
Tokushima University Graduate School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima
Tel
0886339295
awachiken@tokushima-u.ac.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
徳島大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None noted
Management information
Registered date
| 2023 | Year | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060201
