Scalp Cooling Cap Shows Success in Reducing Hair Loss Due to Chemotherapy

Scalp Cooling Cap Shows Success in Reducing Hair Loss Due to Chemotherapy

Using scalp cooling cap for chemotherapy patients during a clinical trial, researchers have reported success in reducing hair loss for cancer patients. Scalp cooling caps were approved by the U.S. FDA last year. Cancer patients undergoing chemotherapy face many side effects due to treatment and hair loss is a major blow to body image of cancer patients. The hair loss caused by chemotherapy has been termed as a major concern for female cancer patients. The new study was conducted on breast cancer patients and found even after four chemotherapy cycles, majority of patients retained good amount of hair.

The results of clinical trial involving 95 breast cancer patients were presented at the San Antonio Breast Cancer Symposium on Friday. The research team added that they halted the study early as they witnessed positive outcomes at early stage.

Chemotherapy attacks rapidly dividing cells and the current treatment kills other cells along with cancer cells. Hair fall is caused by chemotherapy as hair cells also divide faster compared to other cells. Most chemotherapy patients face hair loss after treatment.

The research team offered silicone scalp cooling caps to breast cancer patients 30 minutes before they were to be administered chemotherapy dosage. The patients kept scalp cooling cap for 90 minutes after the chemotherapy was over. The study involved Stage 1 or 2 breast cancer patients.

Independent evaluators were asked to analyze hair loss among study group patients after four sessions of chemotherapy. Patients using scalp cooling cap had normal looking hair from distance. In most of the cases, the patients didn’t need a wig to mask hair loss due to chemotherapy.

The primary endpoint was the proportion of patients who had grade 0 (none) or grade 1 (50%) hair loss as compared with grade 2 (>50%). The trial ended prematurely when a planned interim analysis showed a statistically significant advantage for the scalp-cooling device.

Last year, FDA approved DigniCap Scalp Cooling System. The study was funded by Paxman Cooling. The clinical trial tested the Orbis Paxman Hair Loss Prevention System, which is currently under FDA review by the FDA.

The research was led by Dr. Julie Nangia, assistant professor in the Lester and Sue Smith Breast Center within the NCI-designated Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine.

“Chemotherapy treatment works by attacking rapidly dividing cells, but in doing this, it also targets rapidly-dividing hair cells, 90 percent of which are in the growth stage, resulting in hair loss,” said Nangia. “With scalp cooling, we are lowering the temperature of the scalp, thereby constricting the blood vessels and reducing the flow of blood to the hair follicles, which will help reduce hair loss by limiting the amount of chemo drugs reaching the follicles.”

At a 50 percent success, the trial’s results crossed the superiority boundary and resulted in researchers ceasing to accrue patients and halting the study early to release the data.

Throughout the trial, mild side effects such as headaches and temporary discomfort were reported. Patients involved in the scalp cooling study will be followed for five years to determine any adverse effects.

“Variation in hair retention across the sites is likely a result of different types of chemotherapy administered – taxanes have higher hair retention rates – and the learning curve for fitting and operating the scalp cooling cap by nurses and physicians,” explained Nangia. “As the cap becomes more widely-used, best practices will be developed to ensure maximum results.”

The trial shows that scalp cooling using the Orbis Paxman Hair Loss Prevention System is effective in hair preservation and should become available for patients who receive chemotherapy for early-stage breast cancer.

“We chose to focus this study on women with breast cancer because of its prevalence and large patient population, and women are more emotionally sensitive to hair loss in general,” said Nangia. “Preventing hair loss may help improve the emotional well-being for patients and help them maintain a degree of privacy.”


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