Hand and Foot Skin ReactionPhase 2NCT05289726
Study on the Prevention of Dermal Toxicity Caused by Regorafenib by Traditional Chinese Medicine TDX105
A Phase 2 study testing Traditional chinese medicine TDX105 in people with Hand and Foot Skin Reaction and Colorectal Cancer Stage IV, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
this is an preventive study to evaluate the preventive effect of traditional chinese medicine TDX105 on Regorafenib induced Dermatologic Toxicities Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand and Foot Skin Reaction, Colorectal Cancer Stage IV
- What is being tested?
- Traditional chinese medicine TDX105
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2022to 18 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Clinically confirmed colorectal cancer patients;
- It is planned to use the targeted drug regorafenib for the first time, and the initial dose is 120mg/d;
- Performance Status score ≤3;
- Age ≥18; 5, no intellectual and mental disorders, normal language expression ability, ability to judge their own symptoms
- 6. Understand and agree to accept the treatment, and sign the informed consent.
Who cannot join
- Patients with skin reactions affected by simultaneous use of other targeted drugs (sorafenib, sunitinib, fruquintinib, etc.), chemotherapy drugs (capecitabine, doxorubicin, etc.) or hand-foot radiotherapy;
- Patients with skin diseases such as eczema, psoriasis and tinea pedis at observed skin sites (namely hands and feet); Patients with skin allergic diseases;
- Patients in the study who cannot cooperate with the continuation of this treatment;
- Sudden changes in the patient's condition affected and interfered with the researcher
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer hospital Chinese academy of Medical sciences
Beijing, Beijing Municipality, 100021
Libo Yao, 010-87788446, hejie@cicams.ac.cn
About this study
Official title: Randomized Controlled Clinical Trials to Evaluate the Preventive Effect of Traditional Chinese Medicine TDX105 on Anti-tumor Target Therapy Regorafenib Induced Dermatologic Toxicities
this is an preventive study to evaluate the preventive effect of traditional chinese medicine TDX105 on Regorafenib induced Dermatologic Toxicities
Read the detailed description
this is an double blinded controlled preventive study to evaluate the preventive effect of this is an preventive traditional chinese medicine TDX105 plus Urea Ointment compared with placebo plus Urea Ointment on Regorafenib induced Dermatologic Toxicities
- Being tested
- Traditional chinese medicine TDX105, Placebo
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional chinese medicine TDX105Drug
Experimental group Traditional chinese medicine TDX105
PlaceboDrug
he control group received placebo granules mixed with dextrin and food coloring
| Study group | Role | What they receive |
|---|---|---|
| Traditional chinese medicine TDX105 | Experimental | * Experimental group Traditional chinese medicine TDX105 (Dissolve in warm water and then dilute to 600ml and soak hands and feet for 30 minutes each time, once in the morning and evening every day, until the end of the first 8 weeks of treatment with regorafenib)
* Basic care was the same in both groups, including routine care such as topical use of urea ointment Receives: Drug: Traditional chinese medicine TDX105 |
| placebo | Placebo comparator | The control group received placebo granules mixed with dextrin and food coloring (Dissolve in warm water and then dilute to 600ml and soak hands and feet for 30 minutes each time, once in the morning and evening every day, until the end of the first 8 weeks of treatment with regorafenib)
- Basic care was the same in both groups, including routine care such as topical use of urea ointment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of grade 3 hand-foot skin reaction
Evaluation criteria for common adverse events (CTCAE) 5.0
Measured: Once a week from the beginning to 2 months
Secondary outcomes (4)
Grade 1-2 hand and foot skin reaction rate
Evaluation criteria for common adverse events (CTCAE) 5.0
Measured: Once a week from the beginning to 2 months
Withdrawal rate of regorafenib within 2 cycles
Weekly telephone follow-up
Measured: Once a week from the beginning to 2 months
progression-free survival
Response Evaluation Criteria In Solid Tumors 1.1
Measured: Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months.
tumor control rate
Response Evaluation Criteria In Solid Tumors 1.1
Measured: Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start18 Apr 2022 (estimated)
- Primary completion18 Jul 2022 (estimated)
- Study completion18 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand and Foot Skin ReactionStudies 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
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289726
- Sponsor's protocol ID
- APL21100510010105003002
- Status last verified
- Mar 2022
- First submitted
- 10 Dec 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Do not participate in data sharing
Publications
Yu S, Hu X, Tan Y, Wang C, Shao Z, Xiao Y, Liu H, Lv J, Li S, Jiang X, Zeng L, Tian A. Prophylactic effect of the traditional Chinese medicine formula danxiong granules (TDX105) on hand-foot skin reaction associated with the antitumor targeted drug regorafenib: a randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2025 Nov 6;16:1641477. doi: 10.3389/fphar.2025.1641477. eCollection 2025.
PubMed 41282614
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trials to Evaluate the Preventive Effect of Traditional Chinese Medicine TDX105 on Anti-tumor Target Therapy Regorafenib Induced Dermatologic Toxicities
- ClinicalTrials.gov ID
- NCT05289726
- Acronym / sponsor ID
- APL21100510010105003002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 18 Apr 2022 (estimated)
- Primary completion
- 18 Jul 2022 (estimated)
- Study completion
- 18 Apr 2023 (estimated)
- First posted
- 21 Mar 2022 (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 is an preventive study to evaluate the preventive effect of traditional chinese medicine TDX105 on Regorafenib induced Dermatologic Toxicities
Detailed description
this is an double blinded controlled preventive study to evaluate the preventive effect of this is an preventive traditional chinese medicine TDX105 plus Urea Ointment compared with placebo plus Urea Ointment on Regorafenib induced Dermatologic Toxicities
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional chinese medicine TDX105 | Experimental | Drug: Traditional chinese medicine TDX105* Experimental group Traditional chinese medicine TDX105 (Dissolve in warm water and then dilute to 600ml and soak hands and feet for 30 minutes each time, once in the morning and evening every day, until the end of the first 8 weeks of treatment with regorafenib) * Basic care was the same in both groups, including routine care such as topical use of urea ointment |
| placebo | Placebo comparator | Drug: PlaceboThe control group received placebo granules mixed with dextrin and food coloring (Dissolve in warm water and then dilute to 600ml and soak hands and feet for 30 minutes each time, once in the morning and evening every day, until the end of the first 8 weeks of treatment with regorafenib) - Basic care was the same in both groups, including routine care such as topical use of urea ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically confirmed colorectal cancer patients;
- It is planned to use the targeted drug regorafenib for the first time, and the initial dose is 120mg/d;
- Performance Status score ≤3;
- Age ≥18; 5, no intellectual and mental disorders, normal language expression ability, ability to judge their own symptoms
- 6. Understand and agree to accept the treatment, and sign the informed consent.
Key exclusion criteria (4 listed)
- Patients with skin reactions affected by simultaneous use of other targeted drugs (sorafenib, sunitinib, fruquintinib, etc.), chemotherapy drugs (capecitabine, doxorubicin, etc.) or hand-foot radiotherapy;
- Patients with skin diseases such as eczema, psoriasis and tinea pedis at observed skin sites (namely hands and feet); Patients with skin allergic diseases;
- Patients in the study who cannot cooperate with the continuation of this treatment;
- Sudden changes in the patient's condition affected and interfered with the researcher
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 TDX105Experimental group Traditional chinese medicine TDX105 | Drug | Traditional chinese medicine TDX105 |
| Placebohe control group received placebo granules mixed with dextrin and food coloring | Drug | placebo |
Primary outcome
incidence of grade 3 hand-foot skin reaction
Time frame: Once a week from the beginning to 2 months
Evaluation criteria for common adverse events (CTCAE) 5.0
4 secondary outcomes
Grade 1-2 hand and foot skin reaction rate
Time frame: Once a week from the beginning to 2 months
Withdrawal rate of regorafenib within 2 cycles
Time frame: Once a week from the beginning to 2 months
progression-free survival
Time frame: Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months.
tumor control rate
Time frame: Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Derived from this study: PubMed 41282614Yu S, Hu X, Tan Y, Wang C, Shao Z, Xiao Y, Liu H, Lv J, Li S, Jiang X, Zeng L, Tian A. Prophylactic effect of the traditional Chinese medicine formula danxiong granules (TDX105) on hand-foot skin reaction associated with the antitumor targeted drug regorafenib: a randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2025 Nov 6;16:1641477. doi: 10.3389/fphar.2025.1641477. eCollection 2025.
- Individual participant dataSharing planned: No. Do not participate in data sharing
Related trials for Hand and Foot Skin Reaction
Recruiting
Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction
Hand-foot Syndrome, Hand-foot Skin Reaction
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Traditional chinese medicine TDX105 in people with Hand and Foot Skin Reaction and Colorectal Cancer Stage IV, 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Mar 2022. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aiping Tian, PhD (13651395732, aipingtian@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of grade 3 hand-foot skin reaction (time frame: Once a week from the beginning to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289726, which also lists 1 linked publication.
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 21 Mar 2022.