An interventional study of traditional Chinese medicine hot bag in Chemotherapy, sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Not applicable, Interventional, and Other
The combination of platinum and taxane drugs has a chemotherapy-induced peripheral neuropathy (CIPN) rate of 73% to 83%. Its symptoms can not only limit daily activities and cause a variety of accidental injuries, but also easily cause negative emotions and seriously affect the quality of life. Modern Western medicine lacks effective clinical intervention methods, and the treatment of acupuncture points with traditional Chinese medicine is simple to operate, easy to observe adverse reactions, and is suitable for continuous self-treatment outside the hospital after training, saving patients time to travel to and from the hospital, and high patient acceptance. Due to the similarity of the pathogenesis of some traditional Chinese and Western medicine in CIPN and the effectiveness of its application in patients with DPN, this study evaluated the effect of specific formulations of Chinese medicine on CIPN by comparing the degree of nerve damage between the following formulations of Chinese medicine hot packs in patients with platinum combined with paclitaxel chemotherapy and the control group.
A random group generator was used to divide the sample of 90 cases, and 45 cases in the control group and 45 cases in the intervention group.
Control group: The chemotherapy was strictly followed by the drug use routine, administered by central vein, paclitaxel and platinum administration rate were set at 180ml/h, and routine health guidance was given before and after chemotherapy.
Intervention group: In addition to the usual nursing measures of the control group, traditional Chinese medicine hot bao acupoint treatment and home care were used.
Patients in both the intervention and control groups were assessed for peripheral neuropathy on the 14th day after the completion of each two rounds of chemotherapy, and the NCI-CTCAE, FACT/GOG-Ntx, and KPSS score scales were assigned according to the patient-reported outcomes.
The Fourth Affiliated Hospital of Zhejiang University School of Medicine is the lead sponsor of 90 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All chemotherapies were strictly followed by drug-use routine. The paclitaxel and platinum administration rate were set as 180ml/h. Health guidance should provide before and after chemotherapies, including precautions for chemotherapy, dietary guidance, life guidance, etc. For patients with peripheral neuropathy that gradually worsen and affect muscle and joint functions, environmental management and self-management should be guided to prevent from falls, bumps, scalds, frostbite, sharps and other accidents.
In addition to the usual nursing measures of the control group, traditional Chinese medicine was used for acupoint treatment and home care：Patients are consulted by TCM specialist nurses and join the WeChat group to complete the hot package home care health education. Heat herbal packets and keep the temperature at 40-50 °C, fix the hot bag on the corresponding acupuncture points of each limb for 30 minutes. Chemotherapy should not be used on the same day and the next day, and the rest of the time should be treated with hot package every day.
Other: traditional Chinese medicine hot bag
traditional Chinese medicine hot bag
Sensory neuropathy
National Cancer Institute-Common Terminology Criteria for Adverse Events. Scoring form 1 to 5 degree.
Time frame: 6 months
Motor neuropathy Motor neuropathy
National Cancer Institute-Common Terminology Criteria for Adverse Events. Scoring from 1 to 5 degree.
Time frame: 6 months
Numbness, tingling sensation or comfortlessness in the limbs
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
Time frame: 6 months
Joint muscle pain
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
Time frame: 6 months
Hearing difficulties Hearing difficulties or tinnitus
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
Time frame: 6 months
Pace impairment
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
Time frame: 6 months
Sense of small objects
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Fourth Affiliated Hospital of Zhejiang University School of Medicine