Chemotherapy-induced Peripheral NeuropathyEarly Phase 1NCT07626528
Study of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy
A Early Phase 1 study of Chemotherapy-induced Peripheral Neuropathy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This clinical trial aims to evaluate the efficacy of Wenyang Tongbi Granules (a patented Traditional Chinese Medicine prescription) in treating chemotherapy-induced peripheral neuropathy (CIPN). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Nov 2028
- Phase
- Early Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Patients aged between 18 and 80 years (inclusive).
- Life Expectancy: An anticipated survival time of ≥ 3 months.
- Performance Status \& Organ Function: A Karnofsky Performance Status (KPS) score ≥ 60 and adequate organ function.
- Diagnosis: Histopathologically or cytologically confirmed breast cancer or colorectal cancer.
- Chemotherapy Regimen: Currently undergoing chemotherapy containing taxanes or oxaliplatin.
- Neurotoxicity Grade: Presence of Grade ≥ 2 peripheral neurotoxicity (according to NCI-CTCAE criteria) induced by chemotherapy.
- TCM Syndrome Differentiation: Conforming to the "Yang Deficiency and Collateral Obstruction with Toxin-Stasis Accumulation Pattern" as defined in the Guidelines for Clinical Research of New Traditional Chinese Medicines.
Who cannot join
- Allergy History: Known hypersensitivity to the active ingredients or excipients of the study drug/placebo; history of allergic constitution; or a history of allergies to ≥ 3 substances.
- Comorbidities: Presence of severe psychiatric disorders; or pre-existing conditions such as diabetic neuropathy, hypothyroidism, renal insufficiency, radiculopathy, Charcot-Marie-Tooth disease, or Guillain-Barré syndrome.
- Concomitant Medications: Use of Chinese patent medicines or herbal decoctions specifically for CIPN within 30 days prior to enrollment.
- Compliance: Inability to adhere to the treatment protocol or difficulty in accurately assessing one's own general condition.
- Pregnancy \& Lactation: Pregnant or lactating women.
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
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
About this study
Official title: A Multicenter Evidence-Based Clinical Study on the Safety and Efficacy of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy
This clinical trial aims to evaluate the efficacy of Wenyang Tongbi Granules (a patented Traditional Chinese Medicine prescription) in treating chemotherapy-induced peripheral neuropathy (CIPN). The study compares Wenyang Tongbi Granules with mecobalamin tablets, a standard clinical medication, to determine whether the TCM intervention yields superior outcomes in sensory and motor function of the limbs, as well as overall systemic status, among patients presenting with paresthesia and pain during chemotherapy.
Methods: Participants who develop hand-foot paresthesia or pain during chemotherapy will receive either Wenyang Tongbi Granules or mecobalamin tablets daily for a continuous period of 42 days. Evaluations will be conducted on Day 1, Day 21, and Day 42. Outcome measures include the severity and duration of limb paresthesia, as well as changes in TCM-specific syndromes. Additionally, blood samples will be collected to assess variations in serum levels of multiple cytokines, including interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α), before and after the intervention.
- Being tested
- Wenyang Tongbi Granules and Placebo mecobalamin, Mecobalamin with placebo Wenyang Tongbi Granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wenyang Tongbi Granules and Placebo mecobalaminDrug
Placebo mecobalamin, one capsule per administration, three times daily (tid) with Wenyang Tongbi Granules (10 g/bag), administered as three bags per day for 42 consecutive days
Mecobalamin with placebo Wenyang Tongbi GranulesDrug
Mecobalamin (one capsule) administered three times daily (tid), combined with placebo Wenyang Tongbi Granules containing 5% of the original formula concentration (10 g/bag), administered as three bags per day for 42 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Decotion | Experimental | Wenyang Tongbi Granules Receives: Drug: Wenyang Tongbi Granules and Placebo mecobalamin |
| Placebo of decotion | Placebo comparator | Wenyang Tongbi Granules Placebo Receives: Drug: Mecobalamin with placebo Wenyang Tongbi Granules |
| comparator | Active comparator | Mecobalamin Receives: Drug: Mecobalamin with placebo Wenyang Tongbi Granules |
| Placebo of Mecobalamin | Placebo comparator | Placebo of Mecobalamin Receives: Drug: Wenyang Tongbi Granules and Placebo mecobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The evaluation was conducted with reference to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). The outcomes were classified into four categories: Complete Response (CR), Partial Response (PR), No Change (NC), and Progressive Disease (PD).
The Overall Response Rate (ORR) was calculated as follows:
ORR= Total number of cases Number of CR + PR cases
×100%
Definitions:
Complete Response (CR): Reduction of adverse event grade to Grade 1.
Partial Response (PR): A decrease of at least one grade compared to baseline (pre-treatment).
No Change (NC): No improvement in symptoms or signs; or minimal symptomatic improvement without corresponding sign improvement.
Progressive Disease (PD): An increase of at least one grade compared to baseline (pre-treatment).
Measured: At baseline (before treatment), Day 21, and Day 42.
Secondary outcomes (4)
Improvement rate of EORTC Quality of Life - Chemotherapy-Induced Peripheral Neuropathy（EORTC QLQ-CIPN20）scores.
The improvement rate was calculated using the formula:
(Post-treatment score-Pre-treatment score×100%)/Pre-treatment score. This reflects the change in symptom burden and quality of life related to CIPN. The minimum value is 1 and maximum value is 4,the lower the better.
Measured: At baseline (before treatment), Day 21, and Day 42.
Remission rate of neuropathic pain assessed by Douleur Neuropathique 4 questions(DN4).
Pain remission was evaluated using the Douleur Neuropathique 4 questions (DN4)questionnaire. The remission rate was calculated as:
(Pre-treatment score-Post-treatment score)/Pre-treatment score×100%.The minimum value is 1 and maximum value is 10,the lower the better.
Measured: At baseline (before treatment), Day 21, and Day 42.
Reduction rate of TCM syndrome scores.
According to the Guidelines for Clinical Research of New Traditional Chinese Medicines, the reduction rate was calculated based on the scoring criteria for "Yang Deficiency and Collateral Obstruction with Toxin-Stasis Accumulation Pattern".The minimum value is 1 and maximum value is 4,the lower the better.
Measured: At baseline (before treatment), Day 21, and Day 42.
Numbness distribution and symptom severity scores.
A novel supplementary rating scale was developed by our research group based on existing clinical scales and has been submitted for a national invention patent (Application No. 202511273259.8).The minimum value is 1 and maximum value is 10,the lower the better.
Measured: At baseline (before treatment), Day 21, and Day 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukun Yin, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626528
- Sponsor's protocol ID
- NCC6157
- Status last verified
- Jun 2026
- First submitted
- 25 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Evidence-Based Clinical Study on the Safety and Efficacy of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy
- ClinicalTrials.gov ID
- NCT07626528
- Acronym / sponsor ID
- NCC6157
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 4 Jun 2026 (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.
This clinical trial aims to evaluate the efficacy of Wenyang Tongbi Granules (a patented Traditional Chinese Medicine prescription) in treating chemotherapy-induced peripheral neuropathy (CIPN). The study compares Wenyang Tongbi Granules with mecobalamin tablets, a standard clinical medication, to determine whether the TCM intervention yields superior outcomes in sensory and motor function of the limbs, as well as overall systemic status, among patients presenting with paresthesia and pain during chemotherapy.
Methods: Participants who develop hand-foot paresthesia or pain during chemotherapy will receive either Wenyang Tongbi Granules or mecobalamin tablets daily for a continuous period of 42 days. Evaluations will be conducted on Day 1, Day 21, and Day 42. Outcome measures include the severity and duration of limb paresthesia, as well as changes in TCM-specific syndromes. Additionally, blood samples will be collected to assess variations in serum levels of multiple cytokines, including interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α), before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Decotion | Experimental | Drug: Wenyang Tongbi Granules and Placebo mecobalaminWenyang Tongbi Granules |
| Placebo of decotion | Placebo comparator | Drug: Mecobalamin with placebo Wenyang Tongbi GranulesWenyang Tongbi Granules Placebo |
| comparator | Active comparator | Drug: Mecobalamin with placebo Wenyang Tongbi GranulesMecobalamin |
| Placebo of Mecobalamin | Placebo comparator | Drug: Wenyang Tongbi Granules and Placebo mecobalaminPlacebo of Mecobalamin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: Patients aged between 18 and 80 years (inclusive).
- Life Expectancy: An anticipated survival time of ≥ 3 months.
- Performance Status \& Organ Function: A Karnofsky Performance Status (KPS) score ≥ 60 and adequate organ function.
- Diagnosis: Histopathologically or cytologically confirmed breast cancer or colorectal cancer.
- Chemotherapy Regimen: Currently undergoing chemotherapy containing taxanes or oxaliplatin.
Key exclusion criteria (5 listed)
- Allergy History: Known hypersensitivity to the active ingredients or excipients of the study drug/placebo; history of allergic constitution; or a history of allergies to ≥ 3 substances.
- Comorbidities: Presence of severe psychiatric disorders; or pre-existing conditions such as diabetic neuropathy, hypothyroidism, renal insufficiency, radiculopathy, Charcot-Marie-Tooth disease, or Guillain-Barré syndrome.
- Concomitant Medications: Use of Chinese patent medicines or herbal decoctions specifically for CIPN within 30 days prior to enrollment.
- Compliance: Inability to adhere to the treatment protocol or difficulty in accurately assessing one's own general condition.
- Pregnancy \& Lactation: Pregnant or lactating women.
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 |
|---|---|---|
| Wenyang Tongbi Granules and Placebo mecobalaminPlacebo mecobalamin, one capsule per administration, three times daily (tid) with Wenyang Tongbi Granules (10 g/bag), administered as three bags per day for 42 consecutive days | Drug | Decotion, Placebo of Mecobalamin |
| Mecobalamin with placebo Wenyang Tongbi GranulesMecobalamin (one capsule) administered three times daily (tid), combined with placebo Wenyang Tongbi Granules containing 5% of the original formula concentration (10 g/bag), administered as three bags per day for 42 consecutive days. | Drug | Placebo of decotion, comparator |
Primary outcome
Overall Response Rate (ORR)
Time frame: At baseline (before treatment), Day 21, and Day 42.
The evaluation was conducted with reference to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). The outcomes were classified into four categories: Complete Response (CR), Partial Response (PR), No Change (NC), and Progressive Disease (PD). The Overall Response Rate (ORR) was calculated as follows: ORR= Total number of cases Number of CR + PR cases ×100% Definitions: Complete Response (CR): Reduction of adverse event grade to Grade 1. Partial Response (PR): A decrease of at least one grade compared to baseline (pre-treatment). No Change (NC): No improvement in symptoms or signs; or minimal symptomatic improvement without corresponding sign improvement. Progressive Disease (PD): An increase of at least one grade compared to baseline (pre-treatment).
4 secondary outcomes
Improvement rate of EORTC Quality of Life - Chemotherapy-Induced Peripheral Neuropathy（EORTC QLQ-CIPN20）scores.
Time frame: At baseline (before treatment), Day 21, and Day 42.
Remission rate of neuropathic pain assessed by Douleur Neuropathique 4 questions(DN4).
Time frame: At baseline (before treatment), Day 21, and Day 42.
Reduction rate of TCM syndrome scores.
Time frame: At baseline (before treatment), Day 21, and Day 42.
Numbness distribution and symptom severity scores.
Time frame: At baseline (before treatment), Day 21, and Day 42.
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 4 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Chemotherapy-induced Peripheral Neuropathy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Jun 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 YIN Yukun (010-87788030, qiuque20210303@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: At baseline (before treatment), Day 21, and Day 42.). 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 4 Jun 2026.