Canceled by the investigator. The SND2 treatment in patients with grade 2 Hand Foot Skin reaction(the dampness-heat stasis syndrome): a Multi-Center, randomized, double-blind, placebo-controlled trail

The SND2 treatment in patients with grade 2 Hand Foot Skin reaction(the dampness-heat stasis 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

ChiCTR2300075212

Enrollment

Unknown

Registered

2023-08-29

Start date

2023-09-01

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:SND2+Urea Cream+Clobetasol Propionate Ointment

Western medications group:SND2 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 MKIs or combine with immune checkpoint inhibitors for any advanced soild 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 dampness-heat stasis; 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 drug (celecoxib, ibuprofen, etc.), opioids (OxyContin, Meconidine, etc.) by oral formulation, as well as nonsteroidal antiinflammatory drug (Furtaradin, etc.), and amides (Lidocaine gel, etc.)etc. for external use, in one week; 6. Reduction or interruption of MKIs; 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