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Background: The DigniCap System is an effective scalp cooling device for the prevention of chemotherapy‐induced alopecia in early breast cancer patients. Aim: This prospective study was designed to confirm the efficacy and tolerability of the device, to explore potential factors associated with its efficacy and to collect data on patient perceptions and satisfaction. Methods: Between January 2016 and June 2018, 163 early breast cancer patients eligible for adjuvant chemotherapy were enrolled. Hair loss was assessed using the Dean scale, where a score of 0–2 (hair loss ≤50%) was defined as successful. Results: Hair preservation was successful in 57% of patients in the overall series. The proportion was even higher (81%) in the patient subgroup treated with a paclitaxel and trastuzumab regimen. Side effects (feeling cold, headache, head heaviness, scalp and cervical pain) were mild to moderate and did not correlate with the rate of hair loss. Lifestyle, anthropometric factors and hair characteristics failed to be associated with device efficacy. Conclusions: The DigniCap System was well tolerated and found to be effective in preventing alopecia in early breast cancer patients. Our study failed to identify factors other than type of chemotherapy regimen associated with hair preservation. SUMMARY STATEMENT: What is already known about this topic? While the DigniCap System is known to be effective in preventing chemotherapy‐induced alopecia, nearly 50% of patients do not benefit from its use, and its side effects can be relevant.Identifying factors associated with the efficacy of scalp hypothermia is particularly important to avert the side effects of scalp cooling in patients unlikely to gain any advantage and to avoid unnecessarily prolonging chemotherapy chair occupation in patients at high risk of hair loss. What this paper adds? This single‐centre prospective study involving a relatively large series of breast cancer patients confirmed the efficacy and tolerability of the DigniCap.Our study failed to identify factors other than type of chemotherapy regimen significantly associated with hair preservation. The implications of this paper: Since a high success rate was observed in patients treated with paclitaxel and trastuzumab, use of the DigniCap may be recommended in breast cancer patients receiving this regimen.In other patients, the use of the device should be considered on an individual patient basis, balancing the efficacy rates and the longer duration of chemotherapy administration against the physical and psychological distress linked to hair loss.Oncology nurses can identify patients who are likely to develop early side effects and/or are unlikely to benefit from scalp hypothermia. [ABSTRACT FROM AUTHOR]

Background: Alopecia is one of the most common adverse effects of chemotherapy. It reduces the patient's self-esteem and quality of life and the effect of therapy. Scalp cooling is the only verified current method for prevention but success is not guaranteed, particularly after receiving anthracycline-based combinations. Low-level light therapy has been clinically proven to inhibit the progress of androgenic alopecia. A previous study using human subjects shows limited benefits for low-level light therapy for patients who suffer chemotherapy-induced alopecia but an increase in the number of probes and the optimization of light sources may improve the efficacy. This study determines the efficacy of low-level light therapy for the prevention of chemotherapy-induced hair loss for patients with breast cancer using a randomized controlled trial. Methods: One hundred six eligible breast cancer patients were randomly distributed into a low-level light therapy group and a control group, after receiving chemotherapy. Subjects in the low-level light therapy group received 12 courses of intervention within 4 weeks. Subjects in the control group received no intervention but were closely monitored. The primary outcome is measured as the difference in the hair count in a target area between the baseline and at the end of week 4, as measured using a phototrichogram (Sentra scalp analyzer). The secondary outcomes include the change in hair count at the end of week 1, week 2, and week 3 and hair width at the end of week 1, week 2, week 3, and week 4, as measured using a phototrichogram, and the change in distress, the quality of life, and self-esteem due to chemotherapy-induced alopecia, at the end of week 4, as measured using a questionnaire. Discussion: This study improves cancer patients' quality of life and provides clinical evidence. Trial registration: Registered at ClinicalTrials.gov—NCT05397457 on 1 June 2022. [ABSTRACT FROM AUTHOR]

Chemotherapy induces hair loss in most cancer patients who undergo treatment, which causes them significant psychosocial trauma. Scalp cooling has demonstrated some efficacy in attenuating chemotherapy-induced alopecia, but response rate varies between patients and chemotherapy class. Here, we showcase in rats a proof-of-concept treatment of using subcutaneous hydrogen peroxide and cumene hydroperoxide injections to provide total protection from hair loss against multiple classes of chemotherapy. We found that subcutaneous peroxides induce cell cycle arrest via P53 activation, thereby protecting hair follicles from the cytotoxic effects of chemotherapy on actively dividing cells. This treatment represents a highly effective and accessible way for cancer patients to maintain quality of life while undergoing treatment for cancer. [ABSTRACT FROM AUTHOR]

Background: Chemotherapy-induced alopecia (CIA), although generally reversible, is felt as extremely distressing by patients with breast cancer. A certified medical device (Capelli Naturali a Contatto®-CNC®) was produced to provide patients with a personalized scalp prosthesis, reproducing the patient's original hair, resistant to any type of everyday or sporting activity, and hairdressing.Aims: The present study aimed to evaluate the impact of the CNC® device on the patient's perception of their body image, psychological wellbeing, satisfaction, strengths and weakness of the CNC® device.Method: A pilot study was carried out on 21 patients affected by CIA due to recurrent breast cancer. A mixed quantitative/qualitative method was used, including administering a questionnaire and a focus group.Results: Based on the Body Image Scale, body image perception improved after 3 and 6 months using the device in the 20 patients who answered the questionnaire. No significant change over time emerged for the six dimensions investigated by the Italian version of the Psychological Well-Being Scale. The thematic analysis of the focus groups showed six themes: definition of the prosthetic device, acceptance of the proposal, experience with the conventional wig, strengths, weaknesses, economic issues.Conclusion: Compared to the previous experience of CIA and the standard wig, the use of the CNC® device improved everyday life and may be proposed to women undergoing chemotherapy and expecting alopecia to prevent discomfort, social embarrassment, and compromised body image. [ABSTRACT FROM AUTHOR]

This case study examines a long-term study on patient experience to identify value generated through collaborative medical design research, in developing a scalp cooling device to prevent chemotherapy-induced alopecia (CIA)/hair-loss. Developing a new medical device is long and complex, requiring a cross-platform multi-disciplinary team. User feedback is essential to ensure continuous development to improve efficacy. Qualitative and quantitative data was gathered from chemotherapy patients using scalp cooling in 9 different countries. Analysis of patient experience captures the impact design research has had for scalp cooling patients globally and guides continuous development, placing the patient at the centre of the design method, driven primarily by the aim of maximizing treatment efficacy for all patients and promoting positive patient experiences. Overall, patient experience of scalp cooling using this device is highly positive and impacts significantly on five key areas of wellbeing. The outcomes will help develop an improved cap for global use. [ABSTRACT FROM AUTHOR]

Purpose: To systematically assess the efficacy and side effects of scalp cooling in patients with breast cancer. Methods: A systematic literature search was conducted in October 2020 across Cochrane Library, PubMed, Embase, CINAHL, Web of Science, Scopus, and four Chinese databases (CNKI, Wanfang, SinoMed, and VIP database). Our review included all randomized controlled trials, cohort studies, and cross-sectional studies. Two authors independently searched databases, screened studies, extracted data, and evaluated each included study's methodological quality and risk bias. Meta-analysis was performed using Stata 15.1 software package and Revman 5.3 software, with estimates of scalp cooling effect and its side effects from pooled using a random-effects model. This study has been registered in the International Prospective Register of Systematic Reviews (PROSPERO, CRD42020216224). Results: In total, 755 articles were screened and data from 27 studies involving 2202 participants were used in the meta-analysis. Studies meeting inclusion and exclusion criteria were three randomized clinical trials, 12 cohort studies, and 12 cross-sectional studies. The effectiveness rate of using a scalp cooling device to protect hair was 61% (95% CI: 55 to 67%, I2 = 88%, P = 0.000). However, scalp cooling therapy's side effects are not be ignored, such as headache, dizziness, scalp pain, neck pain, feeling cold, heaviness of the head, skin rash, nausea, and overtightened strap. Conclusions: This review shows that scalp cooling devices can significantly improve the patients with breast cancer chemotherapy–induced alopecia, but the implications of its side effects provide guide for the implementation of this technology. [ABSTRACT FROM AUTHOR]

Background: Chemotherapy‐induced alopecia (CIA) affects 65% of patients receiving chemotherapy regimens and is often identified with the massive hair loss stage. Reflectance confocal microscopy (RCM) is a noninvasive technique used in alopecia assessment for disease characterization and state of activity. Objective: To describe RCM features of CIA in different timing and identify specific phases of alopecia development. Methods: A total of 16 patients treated with chemotherapy underwent dermoscopy and RCM evaluations four times during the observation: 2 and 4‐6 weeks after starting and 3 and 6 months after the end of chemotherapy. Ten examinations for each stage were performed. Results: Four phases of CIA have been identified. Initial hair loss showed specific dots not previously described, named CIA dots. massive hair loss phase was characterized by black dots (10/10 pt), CIA dots (8/10 pt) and hair shaft abnormalities. Three months after the end of chemotherapy, during the partial regrowth phase, 10/10 patients showed thin hair in regrowth and 8/10 presented black and yellow dots. At 6 months, normal hair in regrowth appears in all patients (total regrowth phase). Conclusions: Chemotherapy‐induced alopecia has to be considered as a dynamic process with specific phases characterized by distinctive dermoscopic and confocal features. [ABSTRACT FROM AUTHOR]

Photobiomodulation (PBM) or low-level laser therapy was discovered over 50 years ago, when Mester in Hungary observed regrowth of hair in mice when irradiated with a ruby laser. At the present time, several different PBM devices are marketed to assist with hair regrowth in alopecia patients. This review covers the three main types of alopecia (androgenetic, areata, and chemotherapy-induced), and discusses the mechanism of action of PBM for each disease. The different devices used (mostly low powered red laser diodes), dosimetry, animal models, and clinical trials are summarized. Criteria for patient selection are outlined. Finally a perspectives section looks forward to the future. [ABSTRACT FROM AUTHOR]

Introduction: The use of scalp cooling for the prevention of chemotherapy-induced alopecia (CIA) is increasing. Cold caps are placed onto the hair-bearing areas of the scalp for varying time periods before, during, and after cytotoxic chemotherapy. Although not yet reported, improper application procedures could result in adverse events (AEs). At present, there are no evidence-based scalp cooling protocols, and there is no regulatory oversight of their use. Objective: To report the occurrence of cold thermal injury (frostbite) on the scalp, following the use of cold caps for the prevention of CIA. Materials and methods: We identified four patients who developed cold thermal injuries on the scalp following the application of cold caps. Medical records were analyzed to retrieve the demographic and clinical characteristics. Results: The cold thermal injuries in our patients were grade 1/2 in severity and improved with topical interventions and interruption of cold cap use, although grade 1 persistent alopecia ensued in 3 patients. The true incidence of such injuries in this setting, however, remains unknown. Conclusions: Cold thermal injuries are likely infrequent and preventable AEs that may result from improper device application procedures during cold cap use. Although these untoward events are usually mild to moderate in severity, the potential occurrence of long-term sequelae (e.g., permanent alopecia and scarring) or the need to discontinue cold cap use, are not known. Prospective studies are needed to further elucidate the risk and standardize healthcare delivery methods, and to improve patient/supportive/healthcare provider education. [ABSTRACT FROM AUTHOR]

Epidermal growth factor ( EGF) is not only a cell growth stimulant but also has a catagen-inducing effect. Because chemotherapeutic agents primarily damage anagen hair follicles, it would be important to investigate whether catagen inducers have beneficial effects in chemotherapy-induced alopecia ( CIA). We pretreated hair follicles with topical EGF-liposomal solution in the C57 BL/6 mouse model of cyclophosphamide-induced alopecia and observed the catagen-inducing property and damage response pathway after CIA. We confirmed that topical EGF application induced a catagen-like stage and found that these catagen-like hairs were protected from chemotherapy-mediated damage. Moreover, our results showed that EGF treatment favoured primary hair recovery via the dystrophic anagen pathway after CIA. Given that hair follicles subjected to less severe chemotherapeutic insult enter the dystrophic anagen pathway followed by primary recovery, the results of this study suggest that catagen inducers could be useful as a new alopecia-protection strategy, especially in the context of CIA. [ABSTRACT FROM AUTHOR]