- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05598827
Application of Douyin in Patients With Bone and Soft Tissue Malignant Tumors During Perichemotherapy
To Observe a Single-center, Randomized, Controlled Clinical Study on the Effect of Douyin on the Emotions of Patients With Bone and Soft Tissue Malignant Tumors During Perichemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Men and women aged 10-70. The Eastern Collaborative Oncology Group (ECOG) physical status score was 0-1. Subjects with amputation can be relaxed up to 2 points.
Pathological diagnosis of bone and soft tissue malignancy. Patients who have received at least one previous chemotherapy and are planning to receive new chemotherapy.
All acute toxicities from previous antitumor therapy or surgery resolved to grade 0-1 (according to NCI-CTCAE, version 4.03) or to enrollment/exclusion criteria by day 1 of the first cycle (C1D1), with the exception of toxicities such as hair loss that the investigator considered to pose no safety risk to the subject).
Adequate organ and bone marrow function, as defined below:
Blood routine (no blood transfusion, no G-CSF, no medication correction within 7 days before screening) :
Neutrophil count (ANC)≥1,500/mm3(1.5×109/L); Platelet count (PLT)≥100,000/mm3(100×109/L); Hemoglobin (Hb)≥9g/dL(90g/L);
Blood biochemical:
Serum creatinine (Cr)≤1.5× upper limit of normal (ULN) or creatinine clearance (Cockroft-Gault formula)≥60ml/min; Total bilirubin (TBIL)≤1.5×ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤2.5×ULN, and subjects with liver metastases should ≤5×ULN;
Blood coagulation function:
International normalized ratio (INR)≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5×ULN; With my consent and signed informed consent, I am willing and able to comply with the planned visit, study treatment, laboratory tests and other test procedures.
Exclusion Criteria:
Received the following treatment within 7 days before C1D1:
Radiotherapy, chemotherapy, immune or molecularly targeted therapy for tumors. Some other investigational drugs. Surgery for other sites and/or radiotherapy were planned during the study period (24 hours before chemotherapy and 7 days after chemotherapy).
Imaging diagnosis showed the presence of central nervous system tumor lesions. The presence of active heart disease in the 6 months before C1D1, including myocardial infarction, severe/unstable angina pectoris, etc. Poorly controlled arrhythmias with left ventricular ejection fraction <50% on echocardiography (including QTcF interval >450ms in men and >470ms in women).
In the judgment of the investigator, there are concomitant diseases (such as severe diabetes, neurological or psychiatric diseases) or any other conditions that seriously endanger the safety of the subjects, may confuse the results of the study, or affect the completion of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Watch the Tik Tok
Unlimited Tik Tok viewing was encouraged from 24 hours before chemotherapy until the seventh day after chemotherapy.
|
The enrolled patients were encouraged to watch Tik Tok without limit starting 24 days before chemotherapy and continuing until the seventh day after chemotherapy.
|
No Intervention: Tik Tok is not allowed
Viewing of Tik Tok was prohibited from 24 hours before chemotherapy until the seventh day after chemotherapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety and depression
Time Frame: 24 hours before chemotherapy
|
Hospital Anxiety Depression Scale
|
24 hours before chemotherapy
|
Anxiety and depression
Time Frame: 1 day of chemotherapy
|
Hospital Anxiety Depression Scale
|
1 day of chemotherapy
|
Anxiety and depression
Time Frame: 24 hours after chemotherapy
|
Hospital Anxiety Depression Scale
|
24 hours after chemotherapy
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZZUSC-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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