UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046647 |
|---|---|
| Receipt number | R000053210 |
| Scientific Title | A prospective study to evaluate the feasibility and usefulness of a smartphone site aimed at improving taste disorders and nutritional status in cancer patients undergoing chemotherapy |
| Date of disclosure of the study information | 2022/01/17 |
| Last modified on | 2025/01/17 11:32:02 |
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Basic information
Public title
A prospective study to evaluate the feasibility and usefulness of a smartphone site aimed
at improving taste disorders and nutritional status in cancer patients undergoing chemotherapy
Acronym
OISHY Study
Scientific Title
A prospective study to evaluate the feasibility and usefulness of a smartphone site aimed
at improving taste disorders and nutritional status in cancer patients undergoing chemotherapy
Scientific Title:Acronym
OISHY Study
Region
| Japan |
Condition
Condition
Gastrointestinal caner, Head and neck cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examine whether dietary support for cancer chemotherapy patients can be provided using the Internet, and whether it will improve patient outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Step1 (30 patients): Percentage of patients who completed 9 weeks of input
Step2 (200 people): Weight loss rate of 3% or more before and after the start of treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Nutritional intervention using smartphone site
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) Diagnosed as gastrointestinal cancer / head and neck cancer.
2) We plan to start a new regimen of palliative chemotherapy including cell-killing drugs or preoperative chemotherapy for gastrointestinal / head and neck cancer.
3) Over 20 years old.
4) It can be taken orally.
5) Performance status (PS) 0-2.
6) It does not matter if there is an evaluable lesion.
7) I can understand Japanese.
8) You can continue to input to the smartphone site.
9) The patient himself has given written consent to participate in the study.
Key exclusion criteria
1) Be aware of obvious dysgeusia before starting treatment.
2) Radiation therapy that includes the gastrointestinal tract in the irradiation field will be used in combination.
3) Medical professionals have determined that it is difficult to participate in this study.
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kato |
Organization
National Cancer Center Hospital
Division name
Department of Head and Neck, Esophageal Medical Oncology / Department of Gastrointestinal Medical Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
kenkato@ncc.go.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Kato |
Organization
National Cancer Center Hospital
Division name
Department of Head and Neck, Esophageal Medical Oncology / Department of Gastrointestinal Medical O
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
kenkato@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital,
Institute
Department
Personal name
Funding Source
Organization
Oishi kenko Inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3547-5201
irst@ml.res.ncc.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
| 2022 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/detail/um?trial_id=UMIN000046647
Publication of results
Partially published
Result
URL related to results and publications
https://meetings.asco.org/abstracts-presentations/229225
Number of participants that the trial has enrolled
18
Results
A total of 18 patients (9 with esophageal cancer, 8 with colorectal cancer, and 1 with gastric cancer) were enrolled in this study. Palliative chemotherapy was given to 9 patients and preoperative chemotherapy to 9. AEs (any grade) related to chemotherapy-induced eating disorders were anorexia in 13 patients, dysgeusia in 12, nausea in 10, and oral mucositis in 7. Median food intake and taste scores for all patients were 95.7%, sweet 50.1, salty 50.6, sour 49.6, bitter 48.4, umami 52.0, and spicy 49.5.
Results date posted
| 2025 | Year | 01 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 18 patients (9 with esophageal cancer, 8 with colorectal cancer, and 1 with gastric cancer) were enrolled in this study. Palliative chemotherapy was given to 9 patients and preoperative chemotherapy to 9. AEs (any grade) related to chemotherapy-induced eating disorders were anorexia in 13 patients, dysgeusia in 12, nausea in 10, and oral mucositis in 7. Median food intake and taste scores for all patients were 95.7%, sweet 50.1, salty 50.6, sour 49.6, bitter 48.4, umami 52.0, and spicy 49.5. When assessed by CTCAEs, the following were found: anorexia 94.0%, sweet 49.8, salty 50.7, sour 48.5, bitter 48.0, umami 52.0, spicy 47.0; dysgeusia 95.7%, sweet 48.3, salty 51.3, sour 48.0, bitter 46.2, umami 53.2, spicy 45.6; nausea 92.0%, sweet 50.1, salty 50.6, sour 49.4, bitter 45.8, umami 50.3, spicy 46.4; and oral mucositis 94.1%, sweet 47.6, salty 50.4, sour 47.0, bitter 48.9, umami 52.0, spicy 47.0. Compared with all patients, in anorexia there were no obvious sensitivities for any tastes, but the intake amount was decreased. In dysgeusia, patients less strongly perceived sweet and spicy, but more strongly perceived salty and umami. In nausea, the patients ate less and less strongly perceived bitter, umami, and spicy. In oral mucositis, sweet and sour tastes were perceived less strongly.
Participant flow
A total of 18 patients (9 with esophageal cancer, 8 with colorectal cancer, and 1 with gastric cancer) were enrolled in this study. Palliative chemotherapy was given to 9 patients and preoperative chemotherapy to 9. AEs (any grade) related to chemotherapy-induced eating disorders were anorexia in 13 patients, dysgeusia in 12, nausea in 10, and oral mucositis in 7. Median food intake and taste scores for all patients were 95.7%, sweet 50.1, salty 50.6, sour 49.6, bitter 48.4, umami 52.0, and spicy 49.5. When assessed by CTCAEs, the following were found: anorexia 94.0%, sweet 49.8, salty 50.7, sour 48.5, bitter 48.0, umami 52.0, spicy 47.0; dysgeusia 95.7%, sweet 48.3, salty 51.3, sour 48.0, bitter 46.2, umami 53.2, spicy 45.6; nausea 92.0%, sweet 50.1, salty 50.6, sour 49.4, bitter 45.8, umami 50.3, spicy 46.4; and oral mucositis 94.1%, sweet 47.6, salty 50.4, sour 47.0, bitter 48.9, umami 52.0, spicy 47.0. Compared with all patients, in anorexia there were no obvious sensitivities for any tastes, but the intake amount was decreased. In dysgeusia, patients less strongly perceived sweet and spicy, but more strongly perceived salty and umami. In nausea, the patients ate less and less strongly perceived bitter, umami, and spicy. In oral mucositis, sweet and sour tastes were perceived less strongly.
Adverse events
A total of 18 patients (9 with esophageal cancer, 8 with colorectal cancer, and 1 with gastric cancer) were enrolled in this study. Palliative chemotherapy was given to 9 patients and preoperative chemotherapy to 9. AEs (any grade) related to chemotherapy-induced eating disorders were anorexia in 13 patients, dysgeusia in 12, nausea in 10, and oral mucositis in 7. Median food intake and taste scores for all patients were 95.7%, sweet 50.1, salty 50.6, sour 49.6, bitter 48.4, umami 52.0, and spicy 49.5. When assessed by CTCAEs, the following were found: anorexia 94.0%, sweet 49.8, salty 50.7, sour 48.5, bitter 48.0, umami 52.0, spicy 47.0; dysgeusia 95.7%, sweet 48.3, salty 51.3, sour 48.0, bitter 46.2, umami 53.2, spicy 45.6; nausea 92.0%, sweet 50.1, salty 50.6, sour 49.4, bitter 45.8, umami 50.3, spicy 46.4; and oral mucositis 94.1%, sweet 47.6, salty 50.4, sour 47.0, bitter 48.9, umami 52.0, spicy 47.0. Compared with all patients, in anorexia there were no obvious sensitivities for any tastes, but the intake amount was decreased. In dysgeusia, patients less strongly perceived sweet and spicy, but more strongly perceived salty and umami. In nausea, the patients ate less and less strongly perceived bitter, umami, and spicy. In oral mucositis, sweet and sour tastes were perceived less strongly.
Outcome measures
A total of 18 patients (9 with esophageal cancer, 8 with colorectal cancer, and 1 with gastric cancer) were enrolled in this study. Palliative chemotherapy was given to 9 patients and preoperative chemotherapy to 9. AEs (any grade) related to chemotherapy-induced eating disorders were anorexia in 13 patients, dysgeusia in 12, nausea in 10, and oral mucositis in 7. Median food intake and taste scores for all patients were 95.7%, sweet 50.1, salty 50.6, sour 49.6, bitter 48.4, umami 52.0, and spicy 49.5. When assessed by CTCAEs, the following were found: anorexia 94.0%, sweet 49.8, salty 50.7, sour 48.5, bitter 48.0, umami 52.0, spicy 47.0; dysgeusia 95.7%, sweet 48.3, salty 51.3, sour 48.0, bitter 46.2, umami 53.2, spicy 45.6; nausea 92.0%, sweet 50.1, salty 50.6, sour 49.4, bitter 45.8, umami 50.3, spicy 46.4; and oral mucositis 94.1%, sweet 47.6, salty 50.4, sour 47.0, bitter 48.9, umami 52.0, spicy 47.0. Compared with all patients, in anorexia there were no obvious sensitivities for any tastes, but the intake amount was decreased. In dysgeusia, patients less strongly perceived sweet and spicy, but more strongly perceived salty and umami. In nausea, the patients ate less and less strongly perceived bitter, umami, and spicy. In oral mucositis, sweet and sour tastes were perceived less strongly.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 15 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053210
