Results of the Dutch scalp cooling registry in 7424 patients: analysis of determinants for scalp cooling efficacy.

BACKGROUND: Chemotherapy-induced alopecia is a common consequence of cancer treatment with a high psychological impact on patients and can be prevented by scalp cooling (SC). With this multi-center patient series, we examined the results for multiple currently used chemotherapy regimens to offer an audit into the real-world determinants of SC efficacy. MATERIALS AND METHODS: The Dutch Scalp Cooling Registry collected data on 7424 scalp-cooled patients in 68 Dutch hospitals. Nurses and patients completed questionnaires on patient characteristics, chemotherapy, and SC protocol. Patient-reported primary outcomes at the start of the final SC session included head cover (HC) (eg, wig/scarf) use (yes/no) as a surrogate for patient satisfaction with SC and WHO score for alopecia (0 = no hair loss up to 3 = total alopecia) as a measure of scalp cooling success. Exhaustive logistic regression analysis stratified by chemotherapy regimen was implemented to examine characteristics and interactions associated with the SC result. RESULTS: Overall, over half of patients (n = 4191, 56%) did not wear a HC and 53% (n = 3784/7183) reported minimal hair loss (WHO score 0/1) at the start of their final treatment. Outcomes were drug and dose dependent. Besides the chemotherapy regimen, this study did not identify any patient characteristic or lifestyle factor as a generic determinant influencing SC success. For non-gender specific cancers, gender played no statistically significant role in HC use nor WHO score. CONCLUSIONS: Scalp cooling is effective for the majority of patients. The robust model for evaluating the drug and dose-specific determinants of SC efficacy revealed no indications for changes in daily practice, suggesting factors currently being overlooked. As no correlation was identified between the determinants explaining HC use and WHO score outcomes, new methods for evaluation are warranted.

Results of 20- versus 45-min post-infusion scalp cooling time in the prevention of docetaxel-induced alopecia.

PURPOSE: For patients, chemotherapy-induced alopecia (CIA) is one of the most distressing side effects of treatment. Scalp cooling can prevent or minimise CIA; the results may depend on the duration of cooling. Since a previous study on post-infusion cooling time in patients treated with docetaxel chemotherapy found no difference between 90 and 45 min, we investigated whether hair-preserving results could be maintained with a shorter post-infusion cooling time. METHODS: In this prospective, multi-centre randomised study, 134 patients who started treatment with docetaxel 75-100 mg/m(2) in a 3-weekly schedule were randomly assigned in a 1:1 ratio to a post-infusion cooling time of 45 or 20 min. The primary end point was the need for a wig or other head covering as assessed by the patient. A visual analogue scale (VAS) with a range from 0 (not tolerable) to 10 (very tolerable) was used to measure tolerance. RESULTS: Scalp cooling results were similar for 45- and 20-min post-infusion cooling times. Thirty-three out of 45 patients (73 %) treated with 20 min of post-infusion cooling did not need a form of head covering, compared with 41 out of 52 patients (79 %) treated with 45 min of post-infusion cooling (p = 0.5). The procedure was well tolerated (mean visual analogue score 8.3). Six patients stopped due to intolerance during the first treatment cycle. CONCLUSIONS: A 20-min post-infusion cooling time is effective and tolerable for patients treated with scalp cooling to prevent docetaxel-induced alopecia. TRIAL REGISTRATION: Trialregister.nl Identifier, NTR 1856.

Core temperature affects scalp skin temperature during scalp cooling.

BACKGROUND: The efficacy of hair loss prevention by scalp cooling to prevent chemotherapy induced hair loss has been shown to be related to scalp skin temperature. Scalp skin temperature, however, is dependent not only on local cooling but also on the thermal status of the body. OBJECTIVES: This study was conducted to investigate the effect of body temperature on scalp skin temperature. METHODS: We conducted experiments in which 13 healthy subjects consumed ice slurry to lower body temperature for 15 minutes after the start of scalp cooling and then performed two 12-minute cycle exercise sessions to increase body core temperature. Esophageal temperature (Tes ), rectal temperature (Tre ), mean skin temperature (eight locations, Tskin ), and mean scalp temperature (five locations, Tscalp ) were recorded. RESULTS: During the initial 10 minutes of scalp cooling, Tscalp decreased by >15 °C, whereas Tes decreased by 0.2 °C. After ice slurry ingestion, Tes , Tre , and Tskin were 35.8, 36.5, and 31.3 °C, respectively, and increased after exercise to 36.3, 37.3, and 33.0 °C, respectively. Tscalp was significantly correlated to Tes (r = 0.39, P < 0.01): an increase of 1 °C in Tes corresponded to an increase of 1.6 °C in Tscalp . CONCLUSIONS: Slight cooling of patients with an elevated body temperature during scalp cooling contributes to the decrease in scalp temperature and may improve the prevention of hair loss. This may be useful if the desired decrease of scalp temperature cannot be obtained by scalp cooling systems.

Hair mass index obtained by cross-section trichometry: an objective and clinically useful parameter to quantify hair in chemotherapy-induced alopecia.

PURPOSE: In order to evaluate the efficacy of scalp cooling for the prevention of chemotherapy-induced alopecia (CIA), it is essential to precisely quantify the amount of hair mass that is present. We wanted to determine if the hair mass index (HMI), obtained by cross-section trichometry (CST), was a suitable parameter for hair mass measurement, and whether or not marking the measurement site on the scalp was necessary. METHODS: Ten patients receiving chemotherapy were sequentially measured using CST during their treatment. At the same time, they were asked to report severity of hair loss via three subjective parameters: World Health Organization (WHO) grade, visual analog scale (VAS) score, and patients' need to wear wig or head cover. To investigate the need of marking of the measurement area, differences in HMI between a random 2 × 2-cm site (HMI-C) and four surrounding areas (HMI-S4) on the scalp of eight volunteers and eight chemotherapy patients were calculated and compared. RESULTS: Using CTS, hair loss due to CIA was quite measurable and ranged from 13 to 82 %. Reported VAS scores and WHO grades showed an increase in patients in time; 50 % of patients reported the need to wear a wig or head cover. The difference between HMI-S4 and the HMI-C values in all subjects of the marking group was homogeneously distributed between -11 and +10 and was not statistically different between the volunteer and the patient groups (p = 0.465). CONCLUSIONS: CST for HMI measurement is a useful mechanical modality for assessing hair loss in CIA patients. It is quantitatively more precise than existing non-mechanical measuring methods. It is recommended when detection of minor changes in hair quantity is required. Marking a fixed sampling area to ensure return to the exact same site is only required when a minor change in pre- and posttreatment HMI values is anticipated and the mid-line locating device is not/cannot be used.

Evaluation of Cohen's cross-section trichometer for measuring hair quantity.

BACKGROUND: Until now, there has been no reliable, simple method available for measuring hair quantity that is suitable in clinical practice. Recently, the cross-section trichometer by Cohen has been introduced. This study was designed to test its clinical utility. METHODS: The hair mass index (HMI) is ratio of the cross-sectional area of an isolated bundle of hair and the premeasured area of skin from which it was taken using the trichometer device. The intra- and interobserver reproducibility of measurements at the same location and after relocation were evaluated. RESULTS: For intraobserver reproducibility, the HMI ranged from 3 to 120 (mean difference .2, 95% confidence interval [CI] = -4.7-5.1, correlation coefficient [r] = .99. For interobserver reproducibility, the HMI ranged from 18 to 119 (mean difference -.4, 95% CI = -8,0-7,2, r = .98). With relocation, the HMI ranged from 2 to 113 (mean difference -1.0, 95% CI = -10.1-8.1, r = .97). Measurements took 5-10 minutes per area. CONCLUSION: Measurements were simple to perform, and the data showed high reproducibility. The trichometer is a promising technology for hair quantity measurements and has multiple clinical and research applications.

Unfavourable pattern of metastases in M0 breast cancer patients during 1978-2008: a population-based analysis of the Munich Cancer Registry.

Little is known about time trends in metastases in the patients treated in routine health care facilities without metastases at diagnosis (M0) and about survival after these metastases. Data on 33,771 M0 patients with primary breast cancer diagnosed between 1978 and 2003 were obtained from the Munich Cancer Registry. Survival analyses were restricted to the patients with metastases within 5 years of the initial diagnosis. The incident number of the patients approximately doubled each period and 5-year overall survival increased from 77% in the first to 82% percent in the last period. 5490 (16%) M0 patients developed metastases within 5 years after the initial diagnosis. The hazard of developing metastases was lowest in the most recent period compared to the first period (HR = 0.50, P < 0.001). The hazard of dying after metastases was equal for patients diagnosed between 1978-1984 and 1995-2003 (HR 1.08, P = 0.3). The percentage of the patients that developed bone metastases decreased each time period, but the percentage primary liver and CNS metastases increased. Exclusion of site of metastases in the multivariate analysis led to a 20% (P = 0.02) higher hazard of dying following metastases in the last versus the first period. In the period 1978-2008, unfavourable changes in the pattern of metastases were exhibited and no improvement was observed in survival of the patients after occurrence of metastases. An explanation might be the increased use of adjuvant systemic treatment, which has less effect on the highly lethal liver and CNS metastases than on bone metastases. The increased use also appeared to contribute to the overall prevention of metastases in breast cancer and therefore to improve overall survival.

[Allow scalp cooling during adjuvant chemotherapy in patients with breast cancer; scalp metastases rarely occur]. / Hoofdhuidkoeling toelaten bij adjuvante chemotherapie van borstkankerpatiënten; incidentie hoofdhuidmetastasen zeer gering.

OBJECTIVE: To investigate the incidence of scalp metastases in high-risk breast cancer patients in order to assess whether caution is warranted with scalp cooling during adjuvant therapy. DESIGN: Observational study. METHODS: The incidence of scalp metastases and the disease course were studied in 885 very well evaluated high-risk breast cancer patients. These patients, who had at least four positive axillary lymph nodes, were treated in a randomised study with either classical chemotherapy, or the same chemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation (the so-called N4+ study). RESULTS: After a median follow up of 110 months, 403 of the 885 patients (46%) had relapsed or developed metastases. 25 patients (3%) had developed skin metastasis; 4 of these patients (0.5%) had developed hairy scalp metastasis. The scalp metastases always occurred at the same time as or later than metastases elsewhere. CONCLUSION: Scalp metastases occur with a very low frequency and not as the first sign of metastatic disease. It is therefore unlikely that scalp cooling (to prevent baldness) decreases the local working of chemotherapy to such an extent that the risk of scalp metastases increases.

Impact of alopecia and scalp cooling on the well-being of breast cancer patients.

OBJECTIVE: Chemotherapy-induced alopecia, a common and distressing side effect of chemotherapy, may be prevented by scalp cooling, which reduces toxicity of cytostatics in hair root cells. This is the first study designed to assess the effect of scalp cooling on well-being. METHODS: A prospective multi-centre study was performed in 13 hospitals. Breast cancer patients treated with (N=98) and without (N=168) scalp cooling completed questionnaires (EORTC QLQ-C30 and EORTC-QLQ-BR23, BIS, MBA, HADS) before chemotherapy, and three weeks and six months after the last chemotherapy cycle. RESULTS: Scalp cooling was effective in 52% of the cases. Alopecia was considered among the most distressing problems at all three moments of measurement. A trend towards higher well-being was found in successfully scalp-cooled patients, as indicated by a general better health-related quality of life and better body image, whereas unsuccessfully scalp-cooled patients reported lowest well-being. CONCLUSIONS: Scalp cooling contributes not only to the well-being of successfully scalp-cooled patients but also seems to cause additional distress when patients lose their hair despite scalp cooling. This might be related to disappointment due to alopecia despite scalp cooling or possibly to a general higher biological availability of cytostatics. We recommend additional support for patients when scalp cooling is not successful and to spend more effort to maximise the effectiveness of scalp cooling.

Scalp cooling to prevent chemotherapy-induced hair loss: practical and clinical considerations.

OBJECTIVE: The objective of this prospective multicenter study was to obtain insight into the severity and burden of hair loss among cancer patients treated with chemotherapy. In addition, we described the effectiveness and burden of scalp cooling and the satisfaction with wigs, with hair regrowth, and with body image. MATERIALS AND METHODS: Breast cancer patients treated with (n = 98) and without (n = 168) scalp cooling completed questionnaires before chemotherapy and 3 weeks and 6 months after completion of chemotherapy. RESULTS: Scalp cooling was effective in preventing chemotherapy-induced hair loss in 32 of 62 available patients (52%). Even though patients knew hair loss was temporary, it was a burden to 54% of them (n = 100). Scalp cooling was a burden for only 17 out of 51 patients (33%). Most patients who used a wig or head cover were satisfied with it (82%, n = 126). Patients were moderately satisfied with the regrowth of their hair after chemotherapy (mean 11.6; SD 2.53; range 0-20). Successfully cooled patients rated their hair as less important for their body image compared to patients who did experience hair loss (p = 0.014). DISCUSSION: Chemotherapy-induced hair loss is perceived as burdensome. It may be prevented by offering scalp cooling which is often an effective method to prevent this form of hair loss and is tolerated well by patients. However, if possible, scalp-cooling techniques should be improved and their effectiveness should be increased because if scalp cooling is unsuccessful, patients' rate their hair loss as more burdensome compared to noncooled patients.

What is wrong with the 30-year-old practice of scalp cooling for the prevention of chemotherapy-induced hair loss?

Since about 1970 scalp cooling has been used to prevent chemotherapy-induced hair loss, one of the most common and emotionally distressing side effects of cancer therapy. Generally accepted opinions, uncertainty and controversy, topics to study and recommendations for improving the results of scalp cooling are the subjects of this article which was also presented at the MASCC Symposium, June 2003, Berlin.