A study in cancer patients receiving chemotherapy to find out whether a cream containing 20 percent urea and Pentavitin can prevent hand and foot syndrome and reduce changes in chemotherapy doses.

A prospective single arm Phase 2 study to evaluate the incidence of Grade 2 or higher hand foot syndrome and chemotherapy dose modifications in patients receiving a twenty percent urea and Pentavitin based topical formulation - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/113188

Enrollment

200

Registered

2026-06-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Health Condition 1: C801- Malignant (primary) neoplasm, unspecified

Interventions

Intervention1: 20 percent Urea, Saccharide Isomerate and betaine based topical formulation: All eligible participants enrolled in the study will receive cream of 20 percent Urea, Saccharide Isomerate

Eligibility

Inclusion criteria

Inclusion criteria: Adult cancer patients aged 18 years or older receiving chemotherapy associated with hand-foot syndrome, for example capecitabine or similar agents. Patients initiating chemotherapy in Cycle 1, with supportive skin care initiated at the start of treatment on Cycle 1 Day 1, and with no hand-foot syndrome at baseline. Patients willing to undergo routine clinical assessments during scheduled chemotherapy visits.

Exclusion criteria

Exclusion criteria: Pre-existing severe dermatological conditions involving palms or soles that may interfere with assessment of hand-foot syndrome. Known hypersensitivity to urea, saccharide isomerate, betaine, or any component of the topical formulation. Concurrent participation in an interventional clinical trial specifically targeting prevention or treatment of hand-foot syndrome. Patients unlikely to complete planned chemotherapy or follow-up assessments as determined by the investigator.

Design outcomes

Primary

Measure	Time frame
Incidence of Grade 2 or higher hand-foot syndrome (CTCAE version 5.0), defined as the proportion of patients developing Grade 2 or higher hand-foot syndrome, and frequency of chemotherapy dose modifications (dose reductions, delays, interruptions, or discontinuations) attributable to hand-foot syndrome.Timepoint: Incidence of Grade 2 or higher hand-foot syndrome (CTCAE version 5.0), defined as the proportion of patients developing Grade 2 or higher hand-foot syndrome, and frequency of chemotherapy dose modifications (dose reductions, delays, interruptions, or discontinuations) attributable to hand-foot syndrome.	—

Measure

Time frame

Incidence of Grade 2 or higher hand-foot syndrome (CTCAE version 5.0), defined as the proportion of patients developing Grade 2 or higher hand-foot syndrome, and frequency of chemotherapy dose modifications (dose reductions, delays, interruptions, or discontinuations) attributable to hand-foot syndrome.Timepoint: Incidence of Grade 2 or higher hand-foot syndrome (CTCAE version 5.0), defined as the proportion of patients developing Grade 2 or higher hand-foot syndrome, and frequency of chemotherapy dose modifications (dose reductions, delays, interruptions, or discontinuations) attributable to hand-foot syndrome.

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Secondary

Measure	Time frame
Incidence of any-grade HFSTimepoint: Assessed at each chemotherapy cycle visit from Cycle 1 Day 1 until study completion (up to 6 months).;Time to onset of HFSTimepoint: Measured from Cycle 1 Day 1 to the first documented occurrence of HFS during the study period (up to 6 months).;Patient-reported symptom scores (pain, burning, tingling, dryness, fissuring)Timepoint: Assessed at baseline and at each chemotherapy cycle visit until completion of chemotherapy or up to 6 months.;Impact on hand and foot functionTimepoint: Assessed at baseline and at each chemotherapy cycle visit until study completion (up to 6 months).;Incidence of local adverse events and tolerabilityTimepoint: Continuously monitored from initiation of topical therapy through the end of study follow-up (up to 6 months).	—

Measure

Time frame

Incidence of any-grade HFSTimepoint: Assessed at each chemotherapy cycle visit from Cycle 1 Day 1 until study completion (up to 6 months).;Time to onset of HFSTimepoint: Measured from Cycle 1 Day 1 to the first documented occurrence of HFS during the study period (up to 6 months).;Patient-reported symptom scores (pain, burning, tingling, dryness, fissuring)Timepoint: Assessed at baseline and at each chemotherapy cycle visit until completion of chemotherapy or up to 6 months.;Impact on hand and foot functionTimepoint: Assessed at baseline and at each chemotherapy cycle visit until study completion (up to 6 months).;Incidence of local adverse events and tolerabilityTimepoint: Continuously monitored from initiation of topical therapy through the end of study follow-up (up to 6 months).

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Countries

India

Contacts

Public ContactP Suresh

ARMY Hospital, research and referral, Delhi Cantonment

psuresh_n@yahoo.com8017207678

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026