UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053013 |
|---|---|
| Receipt number | R000060410 |
| Scientific Title | Chemotherapy-Induced Taste alteRation and qUality of life Survey in patients with breast cancer |
| Date of disclosure of the study information | 2023/12/07 |
| Last modified on | 2024/12/06 09:50:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Chemotherapy-induced taste alteration and quality of life survey in patients with breast cancer
Acronym
CITRUS study
Scientific Title
Chemotherapy-Induced Taste alteRation and qUality of life Survey in patients with breast cancer
Scientific Title:Acronym
CITRUS study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of taste alteration due to perioperative chemotherapy on the quality of life of breast cancer patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Taste alteration measured by CiTAS and NRS
Key secondary outcomes
QOL change measured by EORCT-QLQ-30
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Breast cancer patients planned to receive Doxorubicin+Cyclophosphamide(ddAC, Tri-weekly AC),Docetaxel+Cyclophosphamide,or Pembrolizumab+Carboplatin+Paclitaxel as perioparative chemoteherapy.
Key exclusion criteria
1. Patients who have received chemotherapy during the last three years.
2. Patients unable to take oral intake.
3. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2,3 or 4
4. Patients deemed by the investigator to be inappropriate for the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kaede |
| Middle name | |
| Last name | Baba |
Organization
National Cancer Center Hospital East
Division name
Department of pharmacy
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Japan
TEL
0471331111
kababa@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kaede |
| Middle name | |
| Last name | Baba |
Organization
National Cancer Center Hospital East
Division name
Department of pharmacy
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Japan
TEL
0471331111
Homepage URL
kababa@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Kaede Baba
Funding Source
Organization
None
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
Ethics Review Board of the National Cancer Center
Address
5-1-1, Tsukiji, Chuoku, Tokyo,104-0045, Japan
Tel
03-3542-2511
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
国立がん研究センター東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 07 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients will be asked about taste alteration and QOL using a Google form on day 1 of each chemotherapy cycle (before administration of anticancer drugs) and at the end of the fourth cycle (approximately 3-4 weeks after completion of chemotherapy). Taste alteration are assessed using the Chemotherapy-induced Taste Changes Assessment Scale (CiTAS) and the Numeric rating scale (NRS), while QOL is assessed using the EORCT-QLQ-C30. The questionnaire can be linked to the medical record by including initials, date of birth and patient ID. The linked medical record will be used to investigate the patient's background, including age, gender, height, weight, clinical stage, treatment, adverse events, complications, medical history, concomitant medications, and trends in various laboratory values during day 1 of each chemotherapy cycle.
Management information
Registered date
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060410
