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Establishment of medication counseling methods with enhanced support for coping with side effects: control nocebo effect in chemotherapy

Establishment of medication counseling methods with enhanced support for coping with side effects: control nocebo effect in chemotherapy - Effect of enhanced support for coping with side effects on the nocebo effect in chemotherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056068
Enrollment
90
Registered
2024-11-06
Start date
2025-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

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 pr

Sponsors

Kansai Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
rate of no nausea from day1 to day7 after initial chemotherapy

Secondary

MeasureTime frame
1) CR rate 2) CP rate 3) TC rate 4) salivary cortisol and IgA will be assessed at before intervention and day7 from the initial chemotherapy 5) Brief COPE score 6) EQ-5D-5L score 7) coping implementation or not 8) PHQ-9 score 9) ESAS-r-J score

Countries

Japan

Contacts

Public ContactRyohei Fujii

Kansai Medical University Department of Psychosomatic Medicine

fujiir@hirakata.kmu.ac.jp072-804-0101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026