A clinical trial to compare prevention of hand foot skin reaction by application of human platelet-derived growth factor or urea cream among patients with cancer on treatment with oral multikinase inhibitor drugs

Recombinant human platelet-derived growth factor or urea cream in prevention of multitargeted kinase inhibitor-associated hand foot skin reaction: a randomized controlled trial - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075648

Enrollment

150

Registered

2024-10-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: C18- Malignant neoplasm of colon Health Condition 2: C65- Malignant neoplasm of renal pelvis

Interventions

Intervention1: PDGF based topical cream: Application of PDGF based topical cream for patients on Multikinase inhibtor versus urea based cream Dose: PDGF 0.01% gel to the palmar and dorsal surface of

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a diagnosis of renal cell, hepatocellular, thyroid, or colon cancer planned to receive sorafenib, sunitinib, cabozantinib, or regorafenib. b) Age greater than 18 years c) Informed consent available d) Life expectancy greater than 12 weeks e) Eastern Cooperative Oncology Group (ECOG) performance status 0-2 f) Study treatment both planned and able to start within 14 days of randomization g) Willing and able to comply with all study requirements, including treatment (applying PDGF or urea based cream), timing and/or nature of required assessments

Exclusion criteria

Exclusion criteria: a) Pre-existing grade 2 or higher neuropathy confounding assessment of HFS b) Other dermatologic condition, that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment c) Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety. d) Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol. e) Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
To compare the incidence of grade 1-3 Multikinase inhibitor-associated hand-foot skin reactions (HFSR) in patients receiving topical urea cream versus Platelet derived growth factor (PDGF) cream Timepoint: Assessment at: Baseline 4 weeks	—

Secondary

Measure	Time frame
To compare the proportion of patients requiring dose reductions due to HFSR Timepoint: 4 weeks;To compare the quality of life of patients in the two armsTimepoint: 4 weeks;To assess adherence with application of urea based and PDGF creamsTimepoint: 4 weeks;To assess the time to develop HFSRTimepoint: 4 weeks;To assess the safety profile (NCICTCv5.0 all grade HFSR)Timepoint: 4 weeks	—

Countries

India

Contacts

Public ContactGhazal Tansir

AIIMS New Delhi

ghzl_complique@yahoo.com9958703810

Outcome results

None listed

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