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A randomized controlled study of a combination of internal and external treatments for albumin paclitaxel-related peripheral neurotoxicity

A randomized controlled study of a combination of internal and external treatments for albumin paclitaxel-related peripheral neurotoxicity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006029
Enrollment
Unknown
Registered
2022-05-22
Start date
2022-05-11
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Peripheral neurotoxicity due to albumin paclitaxel

Interventions

One:Oral herbal group alone
Two:Bloodletting group alone
Four:Blank control group
Three:Chinese medicine combined with four end bloodletting groups

Sponsors

Shanxi Institute of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ?Patients who have pathologically or cytologically confirmed lung cancer or breast cancer. ?Patients' age 18-80 years, regardless of gender. ?Patients with a KPS score = 60 and an expected survival of not less than 3 months. ?Patients who have developed peripheral neurotoxicity after receiving albumin paclitaxel treatment. ? no major visceral organ dysfunction and no cardiovascular or cerebrovascular complications. ? Skin of all four limbs is intact. ? Those who can understand the situation of this study, voluntarily accept the TCM treatment and voluntarily accept the questionnaire for good compliance.

Exclusion criteria

Exclusion criteria: ?Patients with reduced platelets prone to bleeding. ?Those who do not meet the above inclusion criteria. ?Patients who have symptoms related to nerve compression due to brain metastases or who have peripheral nerve damage due to tumour compression. ?Patients with other previous peripheral neuropathies, e.g. neurological diseases, orthopaedic related diseases, peripheral neuropathies due to circulatory disorders. ? those with a history of allergy to drug exposure or the presence of skin lesions on the hands and feet (e.g. eczema). ? Those who are unable to cooperate with treatment. ?Women during pregnancy or breastfeeding. ?Those currently or within 4 weeks participating in other clinical trials. ?Allergic individuals who are susceptible to hypersensitivity to the drug.

Design outcomes

Primary

MeasureTime frame
EORTC QLQ-CIPN20 Neurotoxicity Evaluation Criteria;

Secondary

MeasureTime frame
Peripheral neurotoxicity symptom score;Electromyography;WHO classification of antineoplastic drugs for peripheral neurotoxicity;NCI-CTCAE5.0 Peripheral Neurotoxicity Classification;

Countries

China

Contacts

Public ContactLi Xiaoli

Shanxi Provincial Hospital of Traditional Chinese Medicine

fangliaokelixiaoli@163.com13133000182

Outcome results

None listed

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