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Trial Title:
Application of Douyin in Patients With Bone and Soft Tissue Malignant Tumors During Perichemotherapy
NCT ID:
NCT05598827
Condition:
Malignant Tumor
Chemotherapy
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Tik Tok
Description:
The enrolled patients were encouraged to watch Tik Tok without limit starting 24 days
before chemotherapy and continuing until the seventh day after chemotherapy.
Arm group label:
Watch the Tik Tok
Summary:
A total of 90 patients with bone and soft tissue malignancies who planned to receive
chemotherapy were enrolled in this study in Henan Cancer Hospital. They were divided into
experimental group and control group for anxiety and depression value 24 hours before
chemotherapy, anxiety and depression value on the day of chemotherapy, anxiety value and
depression value 24 hours after chemotherapy. To evaluate the effects of watching Tik Tok
on perichemotherapy anxiety and depression in patients with bone and soft tissue
malignant tumors who were to receive chemotherapy, and to evaluate the effects of
watching Tik Tok on the incidence of chemotherapy-related complications in patients with
bone and soft tissue malignant tumors who were to receive chemotherapy.
Detailed description:
A total of 90 patients with bone and soft tissue malignancies who were scheduled to
receive chemotherapy were enrolled in this study in Henan Cancer Hospital. They were
divided into experimental group and control group: experimental group: Patients enrolled
in this study were encouraged to watch Tik Tok without limit from 24 hours before
chemotherapy to the seventh day after chemotherapy. Control group: Viewing Tik Tok was
forbidden from 24 hours before chemotherapy to the seventh day after chemotherapy.
Anxiety and depression 24 hours before chemotherapy, anxiety and depression 24 hours
after chemotherapy, and anxiety and depression 24 hours after chemotherapy. To evaluate
the effects of watching Tik Tok on perichemotherapy anxiety and depression in patients
with bone and soft tissue malignant tumors who were to receive chemotherapy, and to
evaluate the effects of watching Douyin on the incidence of chemotherapy-related
complications in patients with bone and soft tissue malignant tumors who were to receive
chemotherapy.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
10 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
December 28, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05598827
