cancer-related fatigue
Conditions
Interventions
the intervention group:the intervention group used the experimental device, the hydrogen and oxygen oxygen machine produced by Shanghai Asclepius Meditec Co., Ltd.
the control group:the control group used the control device, the air machine produced by Shanghai Asclepius Meditec Co., Ltd.
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Both male and female, aged 18-75 years; 2. Patients with diagnosed cancer; 3.No surgery planned in the next 3 months (including postoperative patients) and currently receiving systemic antitumor therapy; 4.The 8-item CIS Fatigue rating molecular scale (CIS-Fatigue) >35; 5.Eastern Cooperative oncology Group (ECOG) performance status <= 2; 6.The expected survival time is more than 12 months; 7.Can independently complete the relevant scale scores; 8.They voluntarily participated in this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with severe mental illness (such as severe depression, schizophrenia, etc.) or cognitive impairment (dementia, delirium, etc.), unable to cooperate to complete the study; 2.Patients with other serious comorbidities (such as heart failure, liver failure, and renal failure), which may interfere with the evaluation of patients in the study; 3.Severe pain that could not be controlled currently, severe infection that could not be corrected, or severe anemia (hemoglobin <60 g/L); 4.Current use of the following medications: ginsenoside-containing drugs, methylphenidate, modafinil, phenobarbital, phenytoin sodium, primidone, probutazone, monoamine oxidase inhibitors, clonidine, and tricyclic antidepressants; 5.Known infectious diseases such as hepatitis B, hepatitis C, AIDS, syphilis and connective tissue diseases in active stage; 6.Known to be intolerant to inhalation therapy; 7.Women who are pregnant, breastfeeding, and planning to become pregnant within 1 year of participating in the trial; 8.Those who are participating in other clinical trials; 9.And the subject was considered by the investigator to have other conditions that could interfere with the evaluation of effectiveness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the CIS-Fatigue score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| the CIS-Fatigue score ;European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 fatigue scores;Pittsburgh Sleep Quality Index (PSQI) ;Hospital Anxiety and Depression Scale;The number of immune cells and cellular immune function;Device performance evaluation ; | — |
Countries
China
Contacts
Public ContactTang Lili
Beijing Cancer Hospital
Outcome results
None listed