Cancer
Conditions
Interventions
Oral steroid administration 2 mg betamethasone, twice a day, total of 4 mg a day during a week.
Oral placebo capsule administration twice a day during a week.
Sponsors
Kyoto University, School of Public Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The patient is diagnosed with stage 4 cancer, in which surgery aimed at complete recovery is impossible, and a decision has been made to prioritize palliative care over cancer treatment with the aim of maintaining/improving QOL. (2) Prognosis of the cancer has been judged by two members of the medical team to be approximately 4-8 weeks. The two members must have a good understanding of the patient's symptoms and include at least one physician. (3) The age when informed consent was obtained is between 20 and 89 years. (4) During the examination, the patient answered "quite a bit" or"very much"to at least one of the 3 questions below, from among the following response options: "not at all," "a little," "quite a bit," and "very much." 1) Have you felt weak? 2) Were you tired? (5) The ECOG PS score was 2 or 3. (6) Oral intake of the test drug (capsule) is possible. (7) Written informed consent to participate in the study has been obtained directly from the patient and the family.
Exclusion criteria
Exclusion criteria: (1) The patient was administered a steroid orally or by injection 1 week or less before enrollment. (2) The patient was administered a synthetic progestin 4 weeks or less before enrollment. (3) The patient had surgery 4 weeks or less before the time of enrollment. (4) The patient was undergoing radiation therapy at the time of enrollment. (5) The patient had chemotherapy 4 weeks or less before enrollment. Alternatively, it has been 4 weeks or less after the patient completed chemotherapy. (6) The patient has a prior history of diabetes that involves drug treatment. (7) The patient clearly has an infectious disease complication. (8) The patient has a peptic ulcer as a complication that involves drug treatment. (9) The patient has a mental disorder (including delirium) related to cognitive function. (10) The patient has contraindications to betamethasone tablets that are listed in the package insert. (11) For any other reason, the patient is judged by the physician in charge to be inappropriate as a subject in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue score of EORTC QLQ-C15-PAL | — |
Countries
Japan
Contacts
Public ContactKikuko Miyazaki
Kyoto University School of Public Health, Department of Helath Informatics
Outcome results
None listed