US RANDOMIZED CLINICAL TRIAL

The Paxman Scalp Cooling System was associated with successful hair preservation.

A prospective investigation was recently published in JAMA evaluating the benefits of scalp cooling to prevent chemotherapy-induced alopecia20

  • Efficacy results: scalp cooling was associated with prevention of significant hair loss in
    approximately 50% of women. Higher success rates were shown in patients
    receiving taxane-based regimens.
  • Scalp cooling was generally well tolerated with no severe adverse events. In a minority
    of patients, scalp cooling was associated with headaches

Scalp Cooling Alopecia Prevention (SCALP) trial: Study Design20

  • This was a multicenter, randomized, nonblinded study testing scalp cooling among 182
    women with early-stage breast cancer who were receiving chemotherapy with a taxane,
    anthracycline, or both
  • The mean age of patients was 52.6 years; 36% (n=51) received anthracycline-based
    chemotherapy and 64% (n=91) received taxane-based chemotherapy
  • Primary endpoint was success in hair preservation after the fourth cycle of
    chemotherapy. Secondary endpoints included wig use and scores on the EORTC Quality
    of Life Questionnaire-Core 30, Hospital Anxiety and Depression Scale, and a summary
    score of the Body Image Scale0

There were 7 trial sites across the United States2

  • Baylor College of Medicine
  • Cleveland Clinic
  • Memorial Sloan Kettering Cancer Center
  • Hematology & Oncology Associates of Northern NJ (now Summit Medical Group-MD Anderson Cancer Center)
  • Baylor Sammons Cancer Center
  • Texas Oncology-Medical City Dallas
  • Texas Oncology-Houston Memorial City
  • Memorial Sloan Kettering Cancer Center
  • Hematology & Oncology Associates of Northern NJ (now Summit Medical Group-MD Anderson Cancer Center)

Results from the SCALP Trial

  • At the time of interim analysis, 142 patients were evaluable. Among the patients who were randomized and completed 4 cycles of chemotherapy, 48 of 95 women in the scalp-cooling group had successful hair preservation 50.5% (95% CI, 40.7%-60.4%) compared with 0 of 47 women in the control group 0% (95% CI, 0%-7.6%) (success rate difference, 50.5% [95% CI, 40.5%-60.6%; P<.001])2
  • In an exploratory post hoc analysis that accounted for site effects, the estimated rate of hair preservation with anthracycline-based chemotherapy was 16% (95% CI, 4%-46%), and with taxanes was 59% (95% CI, 27%-84%)2

Hair preservation with Paxman Scalp Cooling vs a control group and with chemotherapy regimens2

Trial Graph

This trial was stopped early for superiority of hair retention2

Hair preservation in the scalp cooling group was statistically greater than that in the
control group (P<.001 by Cochran-Mantel-Haenszel test).

*Results from final analysis

At the time of the final analysis 184 patients were evaluable. Women with breast cancer receiving chemotherapy with a taxane or anthracycline had a 53% rate of hair preservation verses 0% in the control group after 4 cycles of chemotherapy.

Research has shown that scalp cooling is very effective across a wide range of chemotherapy regimens.

Patient-Reported Outcomes/Quality of Life Results2

There were no significant differences between the scalp-cooling group and the control group in the patient-reported outcome of changes in scores on quality-of-life scales from baseline to the end of treatment.

Safety Findings2

  • Of the 101 participants in the scalp-cooling group, 28 (27.7%) had at least 1 adverse event. The most common adverse device effects included headache, nausea, dizziness, chills, paresthesia, pruritus, sinus pain, skin and subcutaneous tissue disorders, and skin ulceration. Only adverse events related to device use were collected; 54 adverse events were reported in the cooling group, all were grades 1 (n=46) and 2 (n=8). Of the grade 2 events, 7 patients had headaches and 1 had scalp pain. There were no serious adverse device events
  • In this study, no patients developed scalp metastases9 – Because of the concern of the potential to develop scalp metastases, study participants will have routine post-study follow-up visits for 5 years to assess safety and overall survival2
Comfort Scale

Conclusions2

Among women receiving adjuvant chemotherapy for early-stage breast cancer, use of scalp cooling vs no scalp cooling was associated with less hair loss. Additional studies will be necessary to assess the long-term efficacy and safety profile associated with scalp cooling.