Summary of clinical study

FDA Clinical Trial Overview

Medical Institutions Participating in the Dignicap Clinical Study

Prior to clearance, the DigniCap® scalp cooling system was clinically studied in women with breast cancer at some of the most prestigious medical centers in the nation:

  • UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California
    Principal Investigator Hope S. Rugo, M.D.
  • Wake Forest Baptist Medical Center, Winston Salem, NC
    Principal Investigator Susan Melin, M.D.
  • Weill Cornell Breast Center, New York, NY
    Principal Investigator Tessa Cigler, M.D.
  • Mount Sinai Beth Israel, Comprehensive Cancer Center, New York, NY
    Principal Investigator Paula Klein, M.D.
  • UCLA’s Jonsson Comprehensive Cancer Center, Santa Monica, CA
    Principal Investigator Sara Hurvitz, M.D.

Conclusion

Overall, the DigniCap® Scalp Cooling System appeared to be safe and well tolerated with only mild discomfort associated with the scalp cooling and effective in reducing the likelihood of chemotherapy-induced alopecia.

Study design

A clinical study comparing hair loss in 117 breast cancer patients who used and did not use the DigniCap® Scalp Cooling System was performed. All patients had either Stage I or Stage II breast cancer and underwent at least 4 cycles of specific chemotherapy regimens. Sixteen of these women did not use the scalp cooling system and 101 patients used scalp cooling.

The average age of the women was 53.0 years (range 28 – 77); 77.4% were White, 10.4% were Black and 9.4% Asian. The most common chemotherapy regimen was docetaxel/cyclophosphamide for 4-6 cycles (75%, 76 of 89 for 4 cycles), with additional regimens including docetaxel/carboplatin (12%), weekly paclitaxel (12%), and docetaxel (1%). Docetaxel/carboplatin and docetaxel were given with HER2-targeted therapy.

The purpose of this study was to understand how well scalp cooling reduced hair loss. The women in the study evaluated hair loss by comparing before and after photographs of their hair using the Dean Scale.

Dean Scale:

  •  Grade 0: no hair loss
  •  Grade 1: > 0 up to 25% hair loss
  •  Grade 2: > 25 up to 50% hair loss
  •  Grade 3: > 50 up to 75% hair loss
  •  Grade 4: > 75% hair loss

Success was defined as a maximum Dean score of ≤ 2 using standardized photographs graded by the patient up to 4 weeks after the last chemotherapy treatment.

Patient satisfaction with using scalp cooling was evaluated with the Alopecia Self-Report questionnaire. Quality of Life and Body Image was evaluated using the EORTC-QLQ-BR23 Questionnaire and the Body Image Scale respectively.

Alopecia Self-Report

Maximum Dean Score (Evaluable Population)

Dean Score

Patients using DigniCap®

Control patients

N

101

16

0 (No Hair Loss)

5 (5.0%)

0 (0.0%)

1 (Greater than 0 up to 25% Hair Loss

31 (30.7%)

0 (0.0%)

2 (Greater than 25 up to 50% Hair Loss)

31 (30.7%)

0 (0.0%)

3 (Greater than 50 up to 75% Hair Loss)

19 (18.8%)

1 (6.3%)

4 (Greater than 75% Hair Loss)

15 (14.9%)

15 (93.8%)

 

Of the 101 women in the study who used the DigniCap® Scalp Cooling System 67 women (66.3%) lost less than half of their hair, when followed for a month after the last chemotherapy cycle. In comparison, 16 women (100%) in the control group lost more than half of their hair.

Success rate was also analyzed by chemotherapy regimen. In patients who used DigniCap® Scalp Cooling System, success was documented in 83.3% (p=0.022) of patients receiving docetaxel/carboplatin, 60.2% (p<0.001) of those treated with docetaxel/cyclophosphamide, and 83.3% (p=0.066) of patients treated with a taxane alone. Success rate did not differ when analyzed by hair thickness, history of previous chemotherapy, median age, median body mass index, use of prior hormone replacement therapy, and menopausal status. At one month after the last chemotherapy treatment, almost half of the women who had used the DigniCap® Scalp Cooling System reported that they never used a wig, cap, scarf or other head cover due to hair loss.

Patient satisfaction

Patients in the study filled out an Alopecia Self-Report questionnaire. Results clearly showed that 101 patients who had an average of 3.6 cycles of chemotherapy and used DigniCap® Scalp Cooling System were satisfied with the decision to use scalp cooling and expressed higher satisfaction with their hair quantity and hair quality as compared to controls. The patient reported satisfaction score (0 to 100), showed a mean score of 87.5 satisfaction with the decision to use scalp cooling, a mean score of 70.9 for hair quantity and a mean score of 69.1 for satisfaction with hair quality.

In patients using DigniCap® Scalp Cooling System, the Alopecia Self-Report questionnaire results showed thick hair in a mean 0.7 study cycles and no change in hair texture in 1.8 study cycles.

In contrast, the 16 patients in the control group had an average of 1.5 cycles before discontinuing reporting due to hair loss. Patient reported satisfaction score (0 to 100) of 25.6 for hair quantity, and a mean score of 37.6 satisfaction with hair quality. Alopecia Self-Report results indicated 0.9 cycles with no significant change in hair texture.

Quality of Life and Body Image

Compared to patients who used the DigniCap® Scalp Cooling System, a greater number of patients in the control group had dry mouth, different than usual taste in food and drink, eyes were painful, irritated or watery, lost hair, upset at hair loss, felt ill or unwell, had hot flushes, had headaches, felt physically less attractive or less feminine due to the disease or treatment from baseline at the last cycle of chemotherapy and the one month follow-up.

Women who used DigniCap® Scalp Cooling System agreed strongly that hair is important for appearance at the baseline (82.2%), last cycle of chemotherapy (80.2%) and one month follow- up (78.7%), while women in the control group agreed strongly that hair is important for appearance at the baseline (50.0%) and the last cycle of chemotherapy (50.0%) and 66.7% at one month follow-up.

Adverse events

Six women reported 7 adverse reactions caused by the DigniCap® Scalp Cooling System. These were headache (4 women), itchiness (1 woman), pain of skin (1 woman) and head discomfort (1 woman); none of these reactions were rated severe and one headache was the only reaction rated moderately severe and the rest were mild.

Three of 106 women discontinued use of scalp cooling because of cold discomfort, while 102 out of 106 women had a feeling of chilliness during the cooling down period.

Less than half of the women (43/106) reported that headaches were triggered or exacerbated by scalp cooling. Although headaches occurred, they were not reported at every cycle of scalp cooling.

Conclusion

Overall, the DigniCap® Scalp Cooling System appeared to be safe and well tolerated with only mild discomfort associated with the scalp cooling and effective in reducing the likelihood of chemotherapy-induced alopecia.

Information for
Patients

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Information for
Healthcare Professionals

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Availability

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