UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056068 |
|---|---|
| Receipt number | R000064068 |
| Scientific Title | Establishment of medication counseling methods with enhanced support for coping with side effects: control nocebo effect in chemotherapy |
| Date of disclosure of the study information | 2024/11/06 |
| Last modified on | 2024/12/11 17:31:23 |
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Basic information
Public title
Establishment of medication counseling methods with enhanced support for coping with side effects: control nocebo effect in chemotherapy
Acronym
Effect of enhanced support for coping with side effects on the nocebo effect in chemotherapy
Scientific Title
Establishment of medication counseling methods with enhanced support for coping with side effects: control nocebo effect in chemotherapy
Scientific Title:Acronym
Effect of enhanced support for coping with side effects on the nocebo effect in chemotherapy
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Psychosomatic Internal Medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluate the effect on the nocebo effect of enhanced support for coping with side effect by pharmacist during medication counseling that provides side effect information
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of no nausea from day1 to day7 after initial chemotherapy
Key secondary outcomes
salivary cortisol and IgA will be assessed at before intervention and day7 from the initial chemotherapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Enhanced support for coping with side effect during medication counseling and receive a form containing information on coping with side effect after the medication counseling.
The contents include pressure points for nausea, diet for anorexia, and aerobic exercise for fatigue, all of which can be performed during hospitalization.
Interventions/Control_2
guidance as usual
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
1) advanced lung cancer patients with no prior chemotherapy
2) planned to receive cisplatin or carboplatin
3) capable of communication and do not have cognitive impairments
4) no known history of central nervous system disease (e.g., brain metastases or a seizure disorder)
5) normal liver and renal function
Key exclusion criteria
1) patients using drugs affecting cortisol (steroids, female hormones, rifampicin, phenytoin, phenobarbital)
We do not exclude patients who use dexamethasone as a countermeasure against nausea and vomiting, as it is necessary when using anticancer drugs with high emetogenic risk.
2) patients with serious electrolyte imbalance
3) patients with nausea or vomiting in the 24 hours before enrollment
4) patients who have been treated with antipsychotic agents such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days prior to enrollment or who are planned to receive such treatment during the study period (patients could receive antipsychotic drugs such as olanzapine and prochlorperazine as antiemetic therapy for treatment or prophylaxis)
5) patients with concurrent abdominal radiotherapy
6) patients who are pregnant and lactating
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Fujii |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata, Osaka
TEL
072-804-0101
fujiir@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Fujii |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
fujiir@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
Kansai Medical University Ethics Review Committee
Address
2-5-1 Shinmachi, Hirakata, Osaka
Tel
072-804-2440
rinriirb@hirakata.kumu.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
| 2024 | Year | 11 | Month | 06 | 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
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064068
