Scalp Cooling for Chemotherapy-Induced Hair Loss
Recruiting in Palo Alto (17 mi)
Overseen ByBeth McLellan, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Montefiore Medical Center
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate hairstyling techniques aimed at increasing efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia, determine scalp cooling effect on persistent chemotherapy-induced alopecia, and elucidate molecular mechanisms and predictive biomarkers associated with scalp cooling success in patients with skin of color receiving chemotherapy for breast or non-small cell lung cancer.
This study is being conducted because prior studies have found scalp cooling to be highly effective in preventing hair loss resulting from chemotherapy. However, minority representation was largely limited in completed trials. A recent study found that scalp cooling devices are less efficacious in patients with skin of color, likely because patients with skin of color have hair is predominantly types 3 (curly) and 4 (kinky), which tend to become bulkier when wet and can interfere with scalp cooling cap fitting. The investigators plan to test two techniques aimed at improving scalp cooling efficacy in patients with skin of color through hairstyling methods that minimize hair volume in order to increase cooling cap to scalp contact: 1) cornrows/braids/twists or 2) water/conditioner emulsion on hair. Preliminary data show that breast cancer patients with type 3 or 4 hair receiving taxane chemotherapy and scalp cooling using these techniques to prepare the hair for scalp cooling cap fitting all experienced hair preservation. Additionally, the investigators will also assess persistent chemotherapy-induced alopecia outcomes and incidence by following patients up to 6 months after completing treatment. Finally, specific gene expression changes in taxane-induced chemotherapy-induced alopecia in vitro have been described previously. The investigators will test the hypothesis that scalp cooling reverses such changes in chemotherapy-induced alopecia, assess for biomarkers predictive for scalp cooling success, and investigate persistent chemotherapy-induced alopecia molecular mechanisms using non-invasive transcriptome sequencing on plucked hair follicles.
How does the Scalp Cooling with Conditioner and Water Emulsion treatment differ from other treatments for chemotherapy-induced hair loss?
This treatment is unique because it combines scalp cooling with a conditioner and water emulsion, which may enhance the cooling effect and improve comfort compared to traditional scalp cooling methods. Traditional scalp cooling typically involves only the use of a cooling cap or device without additional emollients.
125710What data supports the effectiveness of the treatment Scalp Cooling for Chemotherapy-Induced Hair Loss?
Research shows that scalp cooling can help prevent hair loss in some cancer patients undergoing chemotherapy, with about 50% of patients maintaining enough hair to avoid needing a wig. Additionally, a study found that scalp cooling led to faster hair volume recovery after chemotherapy, with 85.7% of patients experiencing significant hair regrowth within 12 weeks.
34689Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does allow for certain concurrent therapies like HER, cisplatin, cyclophosphamide, and doxorubicin.
Eligibility Criteria
This trial is for adults over 18 with breast or non-small cell lung cancer at stages I-III, starting taxane-based chemo. It's specifically for those with curly (type 3) or kinky (type 4) hair who are generally active and can care for themselves. Excluded are individuals with other cancers, certain health conditions like severe anemia or diabetes, a history of migraines, scalp metastases, past specific chemotherapy treatments, or advanced-stage IV cancer.Inclusion Criteria
I will start a chemotherapy treatment with taxane for more than 4 cycles.
I have been diagnosed with early to mid-stage breast or lung cancer.
I can take care of myself but may struggle with hard physical activities.
I am older than 18 years.
Exclusion Criteria
I am scheduled for intense chemotherapy or radiation therapy targeting my skull.
I have previously received chemotherapy or drugs like doxorubicin.
I have a history of migraines, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid issues, cold urticaria, cold agglutinin disease, or scalp metastases.
I use hair weave/extensions and don't plan to remove them.
I do not have any other types of cancer, including blood cancers.
I have mild hair loss.
I have been diagnosed with stage IV breast cancer or non-small cell lung cancer.
Participant Groups
The study tests two hairstyling techniques to improve the effectiveness of scalp cooling in preventing hair loss from chemotherapy in patients of color: one using braids/cornrows/twists and another using water/conditioner emulsion. The goal is to enhance cap-to-scalp contact and assess long-term effects on hair preservation up to six months post-treatment.
3Treatment groups
Experimental Treatment
Active Control
Group I: Scalp cooling with hairstyleExperimental Treatment1 Intervention
Scalp cooling with hairstyle (braids, twists, cornrows) to minimize hair volume and increase scalp cooling cap to scalp contact
Group II: Scalp Cooling with conditioner and water emulsionExperimental Treatment1 Intervention
Scalp cooling after coating hair with conditioner and water emulsion to minimize hair volume and increase scalp cooling cap to scalp contact
Group III: No Scalp CoolingActive Control1 Intervention
Control with no scalp cooling
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Montefiore Medical CenterBronx, NY
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
PaxmanCollaborator
References
What is wrong with the 30-year-old practice of scalp cooling for the prevention of chemotherapy-induced hair loss? [2008]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.
Successful reduction of alopecia induced by anthracycline and taxane containing adjuvant chemotherapy in breast cancer - clinical evaluation of sensor-controlled scalp cooling. [2022]Scalp cooling is a long known method to reduce chemotherapy-induced alopecia in cancer patients with solid tumors. Due to a progress in this method, a medical device enabling individual feedback-controlled temperature regulation was evaluated. Between June 2011 and December 2012, 83 breast cancer patients were included. Evaluation was focussed on the quantification of alopecia, satisfaction and side effects of the scalp cooling system in (neo-) adjuvant chemotherapy regimens. Alopecia quantification was done by patient evaluation and experts rating.
Scalp cooling: a qualitative study to assess the perceptions and experiences of Australian patients with breast cancer. [2018]Chemotherapy-induced hair loss is a common and distressing side effect. Scalp cooling is increasingly being used to reduce this hair loss. The purpose of this study was to explore patients' perceptions and experience of scalp cooling.
The use of scalp cooling for chemotherapy-induced hair loss. [2021]Chemotherapy-induced hair loss is a common and distressing side effect of cancer therapy and is one of the major unmet challenges in cancer management. Scalp cooling can prevent chemotherapy-induced hair loss in some cancer patients with solid tumours receiving certain chemotherapy regimens. Recent evidence indicates that this technique does not increase the risk of scalp metastasis. A reduction in post-chemotherapy infusion duration of scalp cooling and the advancement in cool cap technology may assist clinicians in promoting scalp cooling to cancer patients. This article discusses recent research, scalp cooling guidelines, products available and implications for nurses and their organisations in providing scalp cooling. It also considers recent advancements in identifying genes associated with chemotherapy-induced hair loss and international research collaborations including a registry and a 'chemotherapy-induced hair loss action group'--all striving to improve the patient experience of chemotherapy-induced hair loss.
Sensor-controlled scalp cooling to prevent chemotherapy-induced alopecia in female cancer patients. [2019]Scalp cooling has been used since the 1970s to prevent chemotherapy-induced alopecia, one of the most common and psychologically troubling side effects of chemotherapy. Currently available scalp cooling systems demonstrate varying results in terms of effectiveness and tolerability.
A Clinical and Biological Guide for Understanding Chemotherapy-Induced Alopecia and Its Prevention. [2019]Chemotherapy-induced alopecia (CIA) is the most visibly distressing side effect of commonly administered chemotherapeutic agents. Because psychological health has huge relevance to lifestyle, diet, and self-esteem, it is important for clinicians to fully appreciate the psychological burden that CIA can place on patients. Here, for the first time to our knowledge, we provide a comprehensive review encompassing the molecular characteristics of the human hair follicle (HF), how different anticancer agents damage the HF to cause CIA, and subsequent HF pathophysiology, and we assess known and emerging prevention modalities that have aimed to reduce or prevent CIA. We argue that, at present, scalp cooling is the only safe and U.S. Food and Drug Administration-cleared modality available, and we highlight the extensive available clinical and experimental (biological) evidence for its efficacy. The likelihood of a patient that uses scalp cooling during chemotherapy maintaining enough hair to not require a wig is approximately 50%. This is despite different types of chemotherapy regimens, patient-specific differences, and possible lack of staff experience in effectively delivering scalp cooling. The increased use of scalp cooling and an understanding of how to deliver it most effectively to patients has enormous potential to ease the psychological burden of CIA, until other, more efficacious, equally safe treatments become available.
Hair Loss Prevention by a Scalp Cooling Device in Early Breast Cancer Patients: The Poliambulanza Preliminary Experience. [2019]The most effective agents in the treatment of breast cancer have a common side effect, the hair loss. Some studies reported a reduction of hair loss with the use of the scalp cooling device. Indeed, it decreases the drug accumulation in the hair follicles. We report our preliminary experience with a scalp cooling device in reducing chemotherapy-induced alopecia and related distress in breast cancer patients undergoing adjuvant chemotherapy.
Efficacy of Scalp Cooling in Preventing and Recovering From Chemotherapy-Induced Alopecia in Breast Cancer Patients: The HOPE Study. [2020]Purpose: This study aimed to assess the efficacy of scalp-cooling devices in preventing chemotherapy-induced alopecia in Japanese breast cancer patients and investigate whether a scalp-cooling device improves hair volume recovery over a 12 weeks period after completing chemotherapy. Methods: This multicenter controlled trial included women with breast cancer undergoing chemotherapy in Japan between February 2016 and March 2018. The primary endpoint was the proportion of patients with no alopecia at the end of chemotherapy. The secondary endpoint included hair volume at 12 weeks after completing chemotherapy. Results: A total of 48 patients were enrolled; of them, 34 and 14 were sequentially allocated to the scalp-cooling group using the Paxman Hair Loss Prevention System and the control group, respectively. There was no significant difference in average age between the scalp-cooling and the control groups (50.0 ± 9.6 vs. 49.0 ± 9.0 years). More than 50% of patients in each group had stage II breast cancer (scalp-cooling group: 53.1%; control group: 64.3%), more than 90% received adjuvant chemotherapy (scalp-cooling group: 96.9%; control group: 92.9%), and more than 60% were treated with a docetaxel/cyclophosphamide regimen (scalp-cooling group: 75.0%; control group: 64.3%). There were more patients judged to have no alopecia at the end of chemotherapy in the scalp-cooling group than in the control group (26.7% [8/30] vs. 0% [0/13]; P = 0.011). The proportion of patients with alopecia who experienced an increase in hair volume of ≥50% within 12 weeks duration after chemotherapy was 85.7% (24/28) in the scalp-cooling group and 50.0% (6/12) in the control group. No patient developed serious adverse events related to the scalp-cooling device. Conclusions: The use of a scalp-cooling device prevented alopecia with acceptable safety for Japanese patients. In addition, scalp cooling resulted in faster recovery of hair volume after chemotherapy, even in patients for whom scalp cooling failed to prevent chemotherapy-induced alopecia.
Prospective study of hair recovery after (neo)adjuvant chemotherapy with scalp cooling in Japanese breast cancer patients. [2021]Scalp cooling during chemotherapy infusion to mitigate alopecia for breast cancer patients is becoming widespread; however, studies regarding hair recovery after chemotherapy with scalp cooling are limited. We conducted a prospective study of hair recovery after chemotherapy with scalp cooling.
Scalp cooling for reducing alopecia in gynecology oncology patients treated with dose-dense chemotherapy: A pilot project. [2022]Determine the efficacy of scalp cooling for the prevention of chemotherapy-induced alopecia in gynecology oncology patients.