ChemotherapyNCT06492083
A Stuty on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package
A study testing traditional Chinese medicine hot bag in people with Chemotherapy, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy
- What is being tested?
- traditional Chinese medicine hot bag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult and kinetic patients expected survive with tumor for more than 1 year. Those who use platinum in combination with paclitaxel for chemotherapy for the first time; Voluntarily agree to participate and sign a consent form
Who cannot join
- Those who are allergic to platinum, paclitaxel or Chinese herbal medicine ingredients; Patients with diabetes mellitus, Raynaud's syndrome, central or peripheral nerve disease symptoms; Those who cannot judge their own symptoms; Pregnant / lactating women; Patients with advanced rheumatoid arthritis, severe joint deformity or incapacitation; Those with other immune system diseases； Patients who have not completed the chemotherapy regimen; Patients who were not treated with hot acupuncture points as prescribed (missed dosing ≥ 3 times per week); Incomplete collection of clinical data; Subjects who voluntarily request to withdraw from this treatment, or are unwilling to continue treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine
Yiwu, Zhejiang, 322000
lin dong
About this study
Official title: A Randomized Controlled Clinical Stuty on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package
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.
Read the detailed description
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.
- Conditions
- Chemotherapy
- Being tested
- traditional Chinese medicine hot bag
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy/CIPN, hot compress with chinese herbal packets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional Chinese medicine hot bagOther
traditional Chinese medicine hot bag
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | 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. |
| observation group | Experimental | 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. Receives: Other: traditional Chinese medicine hot bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory neuropathy
National Cancer Institute-Common Terminology Criteria for Adverse Events. Scoring form 1 to 5 degree.
Measured: 6 months
Motor neuropathy Motor neuropathy
National Cancer Institute-Common Terminology Criteria for Adverse Events. Scoring from 1 to 5 degree.
Measured: 6 months
Secondary outcomes (5)
Numbness, tingling sensation or comfortlessness in the limbs
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
Measured: 6 months
Joint muscle pain
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
Measured: 6 months
Hearing difficulties Hearing difficulties or tinnitus
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
Measured: 6 months
Pace impairment
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
Measured: 6 months
Sense of small objects
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start30 Oct 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChemotherapyStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Dong, Bachelor, Principal investigator, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492083
- Sponsor's protocol ID
- KY-2024-076
- Status last verified
- Feb 2025
- First submitted
- 18 Jun 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Stuty on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package
- ClinicalTrials.gov ID
- NCT06492083
- Acronym / sponsor ID
- KY-2024-076
- Conditions
- Chemotherapy
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy/CIPN, hot compress with chinese herbal packets
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –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. |
| observation group | Experimental | Other: traditional Chinese medicine hot bagIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult and kinetic patients expected survive with tumor for more than 1 year. Those who use platinum in combination with paclitaxel for chemotherapy for the first time; Voluntarily agree to participate and sign a consent form
Key exclusion criteria (1 listed)
- Those who are allergic to platinum, paclitaxel or Chinese herbal medicine ingredients; Patients with diabetes mellitus, Raynaud's syndrome, central or peripheral nerve disease symptoms; Those who cannot judge their own symptoms; Pregnant / lactating women; Patients with advanced rheumatoid arthritis, severe joint deformity or incapacitation; Those with other immune system diseases； Patients who have not completed the chemotherapy regimen; Patients who were not treated with hot acupuncture points as prescribed (missed dosing ≥ 3 times per week); Incomplete collection of clinical data; Subjects who voluntarily request to withdraw from this treatment, or are unwilling to continue treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional Chinese medicine hot bagtraditional Chinese medicine hot bag | Other | observation group |
Primary outcome
Sensory neuropathy
Time frame: 6 months
National Cancer Institute-Common Terminology Criteria for Adverse Events. Scoring form 1 to 5 degree.
Motor neuropathy Motor neuropathy
Time frame: 6 months
National Cancer Institute-Common Terminology Criteria for Adverse Events. Scoring from 1 to 5 degree.
5 secondary outcomes
Numbness, tingling sensation or comfortlessness in the limbs
Time frame: 6 months
Joint muscle pain
Time frame: 6 months
Hearing difficulties Hearing difficulties or tinnitus
Time frame: 6 months
Pace impairment
Time frame: 6 months
Sense of small objects
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lin Dong, Bachelor principal investigator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional Chinese medicine hot bag in people with Chemotherapy, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Dong, Bachelor (86+13634187314, dong13634187314@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory neuropathy (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.