An Investigator-Initiated Randomized Controlled Trial of Human Recombinant Platelet-Derived Growth Factor in Addition to Urea Cream for Prevention of Multikinase Inhibitor-Associated Hand-Foot Skin Reaction (HFSR)-PaRTH Trial

Cancer treatment has long relied on powerful drugs that attack tumors directly, but these medicines often carry a heavy price: they can damage the healthy skin on a patient's hands and feet. This condition, known as hand-foot skin reaction, is not merely a rash; it is a painful, blistering, and thickening of the skin that occurs specifically on the palms and soles where pressure is applied. For patients taking a class of targeted drugs called multikinase inhibitors, this side effect is common and severe enough to force them to stop their life-saving treatment or lower the dose, which can compromise their fight against the cancer. The current standard of care involves applying a thick, moisturizing cream containing urea to keep the skin soft, yet despite this routine, nearly half of all patients still develop the painful reaction. Researchers have long searched for a way to stop this cycle of pain and treatment interruption, looking toward the very biological signals that the cancer drugs accidentally block.

A team of investigators at the All India Institute of Medical Sciences in New Delhi has launched a clinical trial to test a new approach to this problem. The study, known as the PaRTH trial, seeks to determine if adding a specific growth factor cream to the standard urea treatment can prevent the skin from breaking down. The researchers are focusing on a substance called recombinant human platelet-derived growth factor, or rhPDGF. In the body, this protein acts as a signal that tells skin cells to move, heal, and repair themselves. The theory driving this study is that multikinase inhibitors work by blocking certain growth signals to stop tumors, but in doing so, they also silence the signals needed for skin repair. By applying a cream that contains a high concentration of this growth factor directly to the hands and feet, the researchers hope to override the drug's side effects and keep the skin intact.

The trial is a large, carefully organized experiment involving patients who are about to start treatment with multikinase inhibitors for various cancers, including kidney, liver, and thyroid cancers. The study is taking place at two major oncology centers in India, where doctors will enroll adult patients who have never taken these specific drugs before. Once a patient agrees to join, they are randomly assigned to one of two groups. One group receives the current standard of care: a 20 percent urea cream applied twice daily to the palms and soles. The other group receives the same urea cream, but they also apply a cream containing the growth factor, rhPDGF, twice a day. To ensure the skin absorbs the treatments correctly, the two creams are applied two hours apart. The patients will continue this routine for four weeks or until they develop the skin reaction or stop their cancer treatment, whichever happens first.

The primary goal of the study is to see if the group using the growth factor cream develops the skin reaction less often than the group using only urea. The researchers expect that while about half of the patients on urea alone will develop the condition, the addition of the growth factor could lower that number significantly. Beyond just counting cases of skin damage, the study also tracks how many patients are forced to reduce their cancer medication because of the pain, how the patients feel about their quality of life, and how long it takes for the skin problems to appear. The team is also carefully monitoring for any safety issues, ensuring that the new cream does not cause unexpected harm.

This investigation represents a shift in how doctors might manage the difficult side effects of modern cancer therapy. Rather than simply treating the pain after it appears, the trial explores whether proactively supporting the skin's natural healing machinery can prevent the damage from happening in the first place. The study is funded by the Indian Council of Medical Research, with the growth factor cream provided by a pharmaceutical partner, and it involves a dedicated team of oncologists, dermatologists, and statisticians working together. While the results are not yet final, the trial is actively recruiting patients and moving forward with the hope that a simple addition to a daily cream routine could allow more patients to stay on their cancer treatments without the debilitating pain of hand-foot skin reaction. If the findings support the initial hypothesis, this approach could become a new standard of care, offering a tangible way to protect the skin and improve the daily lives of those fighting cancer.