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Relationship between dynamic changes in body composition and pharmacokinetics and toxicity and side effects of nab-paclitaxel in northern China

Relationship between dynamic changes in body composition and pharmacokinetics and toxicity and side effects of nab-paclitaxel in northern China

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078985
Enrollment
Unknown
Registered
2023-12-22
Start date
2022-09-19
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumor

Interventions

Muscle reduction group:None

Sponsors

Ordos Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged >= 18 years, pathologically diagnosed malignant tumor to accept Paclitaxel-albumin 260mg/m2 combined with cisplatin 75 mg/m2 or carboplatin AUC >= 5 chemotherapy,and Paclitaxel-albumin was infused in single day; 2.KPS score >=70; 3.Before chemotherapy, liver and kidney function, blood routine, electrocardiogram are normal.Blood tests must meet the requirements of white blood cells > 3.5 * 10^9, neutrophils > 1.5 *10^9, platelets > 85 *10^9, alkaline phosphatase less than 2.5 times of normal value,alanine aminotransferase andaspartate aminotransferase < 2.5 times of normal value, bilirubin 1.5 times of normal value, and creatinine 1.5 times of normal value; 4.No other liver,kidney and blood system diseases. 5.No contraindication of chemotherapy. 6.No intervention (such as surgery) to change body composition before CT and chemotherapy 7.Accept BIA, CT and follow-up. 8.Accept venous blood test after chemotherapy 24 hours. 9.Obtain the patient's informed consent and sign the consent form

Exclusion criteria

Exclusion criteria: 1.Patients who are allergy in Paclitaxel-albumin or platinum. 2.Patients are bedridden and cannot cooperate with nutritional assessment. 3.Patients with other severe consumptive diseases. 4.Patients who had a long history of hormone use. 5.Patients with HIV, active hepatitis, kidney disease and other diseases that affect drug excretion or drug metabolism 6.Patients who are prophylactic application of long-acting leucovorin before chemotherapy. 7.Patients who terminate anti-tumor treatment voluntarily or fail to perform physical analysis or follow-up of side effects according to the rules. 8.Bilirubin > upper limit of normal value 1.5 times, creatinine > upper limit of normal value 1.5 times. 9.Patients with hepatobiliary pancreatic organ metastasis may affect Paclitaxel-albumin metabolism.

Design outcomes

Primary

MeasureTime frame
SMI;LBM;plasma concentration;neuropathic;

Secondary

MeasureTime frame
NRS2002;PG-SGA;

Countries

CHINA

Contacts

Public ContactLIQUANFU

Ordos Central Hospital

1729259137@qq.com+86 477 836 3279

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026