Clinical trial NCT06641934: Current Survey on Chemotherapy-Related Myelosuppression and Clinical Management in Chinese County-level Tumor Patients
Official title: Current Survey on Chemotherapy-Related Myelosuppression and Clinical Management in Chinese County-level Tumor Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myelosuppression
Keywords: Myelosuppression
Lead sponsor: The First Affiliated Hospital of Xinxiang Medical College
Sponsor class: OTHER
Collaborators: name: Xinxiang Central Hospital of Henan province
name: Linzhou People Hospital
name: Inner Huang County Traditional Chinese Hospital
name: Changyuan People Hospital
name: Huojia County People Hospital
name: Huojia County Alliance Hospital
name: Qinyang People Hospital
name: Xinan County People Hospital
name: Henan Hongli Hospital
name: Army Hospital of the 83rd Army
name: Anyang Cancer Hospital
name: Puyang Hospital of Traditional Chinese Medicine
name: Puyang Huimin Hospital
name: Hebi People Hospital
name: The Second People Hospital of Xinxiang Henan
First posted: 2024-10-15
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese County-level Tumor Patients

Brief summary: Current Survey on Chemotherapy-Related Myelosuppression and Clinical Management in Chinese County-level Tumor Patients

Detailed description: The purpose of this research project was to gain an in-depth understanding of the myelosuppression of cancer patients in counties in China after receiving chemotherapy-based treatment regimens through a cross-sectional survey with the help of an online questionnaire system, and to investigate doctors' cognition and treatment concepts of chemotherapy-induced myelosuppression. 1. Fill the gaps in relevant domestic research and provide basic data for follow-up longitudinal studies and intervention studies; 2. Analyze the influencing factors and coping strategies of chemotherapy-induced bone marrow suppression from multiple perspectives, so as to provide reference for improving the knowledge level and treatment level of patients and doctors; 3. Provide more scientific guidance and suggestions for chemotherapy for cancer patients, help patients reduce the harm of bone marrow suppression, improve the survival rate and quality of life of patients, and also provide strong data support for the prevention and treatment of tumors and promote the development of cancer prevention and treatment.

Eligibility criteria: Inclusion Criteria：

* The confirmed malignant tumor is one of the non-small cell lung cancer/small cell lung cancer/breast cancer/gastric cancer/esophageal cancer/colorectal cancer/gynecological malignant tumor (ovarian cancer, cervical cancer, endometrial cancer).
* Patients who need to receive chemotherapy in the past 3 months and should continue to receive chemotherapy in the future
* The relevant diagnosis and treatment information involved in the survey is complete: only patients with at least 1-2 examination results after 1 week after chemotherapy can be included
* Understand and sign the informed consent form
* The chemotherapy regimen received for the most recent chemotherapy should be one of the following

  1. Non-small cell lung cancer TP scheme NP scheme DP scheme EP scheme GP scheme AP scheme Docetaxel/pemetrexed monotherapy Gemcitabine monotherapy Tigio monotherapy ADCs Other monotherapy or combination regimens containing platinum or taxane drugs Drug regimens that combine the above chemotherapy regimens (e.g., immunosuppressants, targeted therapy drugs, etc.)
  2. Small cell lung cancer with etoposide-containing combination regimens Platinum-containing combination regimens (except etoposide) Monotherapy or combination regimen containing topotecan, gemcitabine, paclitaxel Drug regimens that combine the above chemotherapy (e.g., immunosuppressants, targeted therapy drugs, etc.)
  3. reast cancer ddEC sequential T regimen Anthracyclines and taxanes: TAC, TE, EC-T, ddEC-T, FEC-T regimens Combined taxane protocols: TP, AP, TC, Anthracycline combination regimen: EC, FEC Taxane monotherapy Yew combined with platinum Other platinum-containing regimens: NP, GP ADC drugs Microtubule inhibitors: NVB, taxanes (nab-paclitaxel, paclitaxel liposome, docetaxel), eutidrone, eribulin Microtubule inhibitors in combination with capecitabine Anthracycline monotherapy Drug regimens that combine the above chemotherapy (e.g., targeted therapy drugs, etc.)
  4. Gastric cancer SOX protocol XELOX scheme FOLFOX protocol DCF scheme ADCs Other monotherapy or combination regimens containing platinum or taxanes or fluorouracil Drug regimens that combine the above chemotherapy (e.g., immunosuppressants, targeted therapy drugs, etc.)
  5. Esophageal cancer taxane + platinum regimen CF protocol DCF scheme FOLFOX protocol XELOX scheme FLOT scheme FOLFIRI PROTOCOL ECF protocol ECX scheme EOF scheme EOX protocol Other monotherapy or combination regimens containing platinum or taxane or fluorouracil Drug regimens that combine the above chemotherapy (e.g., immunosuppressants, targeted therapy drugs, etc.)
  6. COLORECTAL CANCER FOLFOXIRI FOLFOX FOLFIRI XELOX Other monotherapy or combination regimens containing platinum or fluorouracil or raltitrexed Drug regimens that combine the above chemotherapy (e.g., immunosuppressants, targeted therapy drugs, etc.)
  7. Gynecologic malignancies:platinum + taxane or its combination regimen Monotherapy or combination chemotherapy containing docetaxel/gemcitabine/topotecan/irinotecan Regimens (except platinum + taxanes) Other monotherapy or combination chemotherapy regimens containing platinum, taxanes, or anthracyclines

Exclusion Criteria：

* Patients with concurrent chemoradiotherapy,
* Patients with sequential chemoradiotherapy, and the irradiation site of radiotherapy is flat bone, sternum, and pelvis;
* Patients with active bleeding before or during treatment; If the patient has received targeted drugs such as CDK4/6 inhibitors or chidaaniline in the front-line treatment, which have a great impact on the blood phase, the drug can be discontinued for at least half a month before it can be included
* Patients who, in the opinion of other physicians, would cause non-chemotherapy-related myelosuppression

Primary outcomes:
measure: Incidence of chemotherapy-related myelosuppression and current status of prophylactic therapy
timeFrame: 2024.09-2025.09
Secondary outcomes:
measure: Incidence of chemotherapy-related myelosuppression
timeFrame: 2024.09-2025.09
measure: the rate and economic burden of neutropenia treatment during chemotherapy treatment
timeFrame: 2024.09-2025.09
measure: the incidence of thrombocytopenia and the rate of primary and secondary prevention and treatment during chemotherapy treatment
timeFrame: 2024.09-2025.09
measure: thrombocytopenia treatment rate and economic burden during chemotherapy treatment
timeFrame: 2024.09-2025.09
measure: the incidence and treatment rate of anemia during chemotherapy treatment;
timeFrame: 2024.09-2025.09
measure: Long and/or short acting granulocyte colony-stimulating factor (G-CSF) and/or Chinese patent medicine usage rate and application scenario cost analysis
timeFrame: 2024.09-2025.09
measure: Recombinant human interleukin-11 and/or thrombopoietin (TPO) and/or thrombopoietin receptor agonists (TPO-RA) and/or cost analysis of application scenarios
timeFrame: 2024.09-2025.09
measure: Erythropoietin and/or iron and/or Chinese patent medicine usage rate and application scenario cost analysis
timeFrame: 2024.09-2025.09
Other outcomes:
Locations:
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical College
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Xinxiang Medical College
name: Ji YH yinghua, Dr.
role: STUDY_CHAIR
References: