Canceled by the investigator. The SND1 treatment in patients with grade 2 Hand Foot Skin reaction(the toxic-heat syndrome syndrome): a Multi-Center, randomized, double-blind, placebo-controlled trail

The SND1 treatment in patients with grade 2 Hand Foot Skin reaction(the toxic-heat syndrome syndrome): a Multi-Center, randomized, double-blind, placebo-controlled trail

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300075707

Enrollment

Unknown

Registered

2023-09-13

Start date

2023-09-15

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Hand foot skin reaction

Interventions

Integrated Chinese-Western medicine group:SND1+Urea Cream+Clobetasol Propionate Ointment

Western medicine group:SND1 placebo+Urea Cream+Clobetasol Propionate Ointment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged > 18 years; 2. Patients receiving single VEGFR-TKIs or combined with immune checkpoint inhibitors for any advanced solid tumors; 3. Grade II Hand-Foot-Skin reaction according to NCI-CTC 5.0 standard; 4. Traditional Chinese medicine (TCM) syndrome in patients with Grade II hand-foot skin reaction (HFSR) is the toxic-heat syndrome; 5. KPS >=60, life expectancy >3 months;

Exclusion criteria

Exclusion criteria: 1. Concomitant administration of drugs that can cause HFS eg capecitabine, docetaxel, liposomal doxorubicin, etc. in four weeks; 2. Concomitant administration of drugs that can cause capecitabine eg paclitaxel (Albumin Bound), paclitaxel, oxaliplatin, etc. in four weeks; 3. Any systemic dermatoses or other dermatologic lesions of the hands and feet eg psoriasis, eczema, diabetic foot, peripheral nerve injury of hands and feet, etc; 4. Concomitant administration of drugs that treat HFSR eg urea ointment, hormone ointment, etc.in one week; 5. Concomitant administration of drugs that treat HFSR-related pain eg nonsteroidal antiinflammatory drugs (celecoxib, ibuprofen, etc.), opioids (OxyContin, Meconidine, etc.) by oral formulation, as well as a nonsteroidal anti-inflammatory drug (Furtaradin, etc.), and amides (Lidocaine gel, etc.), etc. for external use, in one week; 6. Reduction or interruption of VEGFR-TKIs; 7. Evidence of other grade 3 or higher antitumor therapy-related adverse reactions other than HFSR; 8. The investigators consider the patients are not suitable for this trial.

Design outcomes

Primary

Measure	Time frame
the change in HFSR grade;	—

Secondary

Measure	Time frame
the change in Traditional Chinese medicine syndrome;the quality of life score;safety;	—

Countries

China

Contacts

Public ContactQijin Shu

The First Affiliated Hospital of Zhejiang Chinese Medical University

shuqjhz@163.com+86 136 0570 6566

Outcome results

None listed

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