UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046997 |
|---|---|
| Receipt number | R000053618 |
| Scientific Title | Effects of cosmetic therapy for cosmetic side effects of chemotherapy on QOL improvement in cancer patients |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2025/02/27 14:06:42 |
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Basic information
Public title
Effects of cosmetic therapy for cosmetic side effects of chemotherapy on QOL improvement in cancer patients
Acronym
Effects of cosmetic therapy for cosmetic side effects of chemotherapy
Scientific Title
Effects of cosmetic therapy for cosmetic side effects of chemotherapy on QOL improvement in cancer patients
Scientific Title:Acronym
Effects of cosmetic therapy for cosmetic side effects of chemotherapy on QOL improvement in cancer patients
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Dermatology | Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating patient quality of life with cosmetic therapy for cancer patients with eyebrow and eyelash hair loss and facial skin disorders due to side effects of chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Skinindex16
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To provide guidance on cosmetic therapy for cosmetic side effects of chemotherapy to the subject, from counseling the subject to guidance on the second cosmetic treatment.
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
Female
Key inclusion criteria
Patients with cancer who are receiving chemotherapy or have received chemotherapy and are able to come to our hospital for cosmetic therapy.
In the JCOG version of the Common Terminology for Adverse Events v5.0, alopecia is Grade 2 or higher among skin and subcutaneous tissue disorders, and skin color excess is Grade 2 or higher among skin and subcutaneous tissue disorders.
Key exclusion criteria
Patients with a history of hypersensitivity reactions such as allergies or skin disorders caused by cosmetics in the past.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shizuyo |
| Middle name | |
| Last name | Tominaga |
Organization
Oita University Hospital
Division name
Nursing Department
Zip code
879-5593
Address
1-1 Idaigaoka Hasamamachi Yufu Oita
TEL
097-586-6132
kango@oita-u-ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Okame |
Organization
Oita University Hospital
Division name
Nursing Department
Zip code
879-5593
Address
1-1 Idaigaoka Hasamamachi Yufu Oita
TEL
097-586-6132
Homepage URL
kango@oita-u-ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Shiseido
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
General Clinical Research Center, Oita University Hospital
Address
1-1, Hasamamachi, Yufu City, Oita
Tel
097-586-6163
gcrcjimu@oita-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
21
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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053618
