Infections

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Respiratory Tract Infections

Alopecia

Alopecia Areata

Hypotrichosis

Hair Diseases

Skin Diseases

Pathological Conditions, Anatomical

Participants receiving cooling cap therapy

Scalp cooling will begin at least 30-45 minutes prior to administration of each chemotherapy (45 minutes for those with thick or coarse hair types). Scalp temperature will be maintained at +3°C (37°F) throughout drug administration and for at least 120-180 minutes after discontinuing the infusion. Scalp cooling will occur with each dose of chemotherapy.

Paxman Scalp Cooling System

Photographs of the hair will be taken before initiation of chemotherapy (baseline) and at a visit 4 weeks (3-6 week window) after the last dose of chemotherapy for those being treated for a non-cancerous condition. Patient with solid tumors will have photographic documentation at baseline, 2-5 weeks after every 2 cycles of chemotherapy, and at end of study (approximately 4 weeks following the last chemotherapy treatment with a range of 3-6 weeks).

Alopecia Assessments

* Selected questions from NCI PRO-CTCAE™, Chemotherapy-Induced Alopecia Distress Scale (CADS), and PediQUEST Memorial Symptom Assessment Scale, at the following time points: baseline, end of chemotherapy administration, and 4 week follow up.
* Tolerability Questionnaire each time the cooling cap is used and at the end of study

Patient Reported Outcomes Questionnaires

Deena Levine, MD

This study is being done to see if the Paxman scalp cooling device can prevent hair loss in pediatric patients receiving chemotherapy for non-cancerous conditions or solid tumors.

Primary Objective

* To assess the safety and feasibility of the use of a scalp cooling device in pediatric and young adult patients receiving chemotherapy for non-malignant conditions and solid tumors.

Exploratory Objectives

* To assess the incidence and intensity of chemotherapy induced hair loss in patients receiving chemotherapy for non-malignant conditions and solid tumors who have used a scalp cooling device.

Participants receiving cooling cap therapy will receive scalp hypothermia as delivered by the scalp cooling system and as per the manufacturers recommendations. Scalp cooling will begin at least 30-45 minutes prior to administration of each chemotherapy (45 minutes for those with thick or coarse hair types). Scalp temperature will be maintained at +3°C (37°F) throughout drug administration and for at least 120-180 minutes after discontinuing the infusion.

A trained study staff member will be present to place the cool cap on the participant, ensure proper fit, begin the cooling process, and ensure functionality. The bedside nurse on the inpatient unit will monitor the participants during the duration of cool cap therapy while also receiving chemotherapy infusion. A trained study team member will be available for any questions or issues that may arise during this time. When the participant is ready to remove the cooling cap a trained study team member will return to shut off the device, remove the cap, and assess the participant.

Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors

COOLCAP: Pilot Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

Proportion or Number of Patients who experience at least one grade 3 or 4 adverse events based on CTCAE when wearing the scalp cooling device.

Proportion of eligible participants who can tolerate at least 70% of the planned scalp cooling therapy. Feasibility will be established if 50% or greater of eligible patients can tolerate at least 70% of the planned scalp cooling therapy and opt to participate.

St. Jude Children's Research Hospital

Neoplasms

Breast Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Taxane

Patients with breast or gynecological cancer planning to undergo chemotherapy Chemotherapy can be neoadjuvant, adjuvant or palliative Up to two lines of chemotherapy are allowed. Adjuvant therapy counts as one line.

Chemotherapy regime is associated with alopecia. Chemotherapy must be planned for at least 4 cycles of taxane or antracycline- based chemotherapy regimen No alopecia of any reason (up-front) No overt cognitive impairment and fluent in German Written informed consent Age 18 and older

For the purpose of comparison, a reference sample will be included in the study applying to the following inclusion criteria:

Patients with breast or gynecological cancer planning to undergo chemotherapy Chemotherapy can be neoadjuvant, adjuvant or palliative Up to two lines of chemotherapy are allowed. Adjuvant therapy counts as one line.

Chemotherapy regime is associated with alopecia. Chemotherapy must be planned for at least 4 cycles of taxane or antracycline- based chemotherapy regimen Refuse to undergo scalp cooling Patients who have been excluded for the study group for the reason of migraine Written informed consent Age 18 and older

Patients from the reference group complete the same survey as the study group. Group comparisons will be adjusted for baseline body image and reasons for refusal.

All patients who accomplish inclusion criteria and do not exhibit any contraindication undergo scalp cooling with the following conditions:

* Minimum 30 minutes pre-infusion cooling
* Cooling for the duration of chemotherapy infusion
* Minimum 90 minutes post-infusion cooling Scalp cooling is performed within the study group at each CT session.

Patients (study group and reference group) will be assessed at the following time Points:

* Baseline
* at the half-way Point of the cyles
* at the last CT cycle
* 3 months after completion of Treatment
* 6-9 months after treatment completion

The assesments include the following

* Photographs of the head, which are evaluated using the CTCAEv4.0
* Questionnaire including the NCI- PRO-CTCAE-ITEMS, EORTC QLQ-C30, EORTC QLQ-B23, Body Image Scale, PRO-CTACAEs and Hairdex questionnaire

Christian Marth, Prof Dr

Chemotherapy (CT) is a frequent and well established treatment in women with breast and gynecological tumors. Alopecia is one of the most common side effects of CT seriously impairing patient quality of life and body image. While other CT associated side effects can be controlled by supportive treatment strategy, adequate preventive measures for alopecia have been lacking. New evidence supports the efficacy of scalp cooling for alopecia prevention during CT.

Scalp cooling using cooling caps has been identified as an effective treatment option against CT-induced alopecia in numerous European countries. Originally, crashed ice was used to cause vasoconstriction and consequently diminish CT uptake to hair follicles during CT. Soon, this method turned out impractically and has been displaced by cooling caps which allow a constant cooling of the scalp while easy handling.

However, effectiveness of scalp cooling depends on different factors such as hair texture, chemotherapy regimen, dose of chemotherapy, cooling time, and compliance of the patient.

Recent studies focused on alopecia prevention more than on patients' quality of life and satisfaction. Therefore, data on routine use of cool caps with a focus on efficiency in daily routine and patients' acceptability are missing.

Patient-reported outcomes (PROs) provide results assessed by the use of a patient's report about his or her own health condition "without amendment or interpretation by a clinician or anyone else" and are a valuable source of information when evaluating clinical interventions or treatment toxicity in intervention studies in oncology. PROs can be perfectly used to evaluate the implication of scalp cooling regarding hair preservation but also quality of life outcome which seems even more important.

Women with breast- or gynecological cancer receiving taxane- or anthracycline-based neoadjuvant chemotherapy are included in the study. Chemotherapy can be neoadjuvant, adjuvant or palliative. Up to two lines of chemotherapy are allowed. Scalp cooling with a maintenance temperature of 17°C will be initiated 30 minutes prior to each chemotherapy cycle and stopped 90 minutes after CT. Patients are assessed for alopecia and qualitiy of life.

Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy

Hair preservation assessed by photo documentation using VAS (Visual Analogue Scale (Grade 1: \< 25% hair loss; Grade 2: 25-50% of hair loss; Grade 3: 50-75%)

CTCAE are descriptive terminology for reporting adverse events including a grading for each of these adverse events. This 5-point grading has a range from mild symptoms requiring no intervention (grade 1) to life-threatening consequences (grade 4) and finally death (grade 5)

The Hairdex questionnaire is a reliable and valid instrument for the evaluation of quality of life in patients with hair diseases (i.e. validated in patients with alopecia diffusa and androgenica). Using a five-point Likert Scale (never=0 to always =4), the questionnaire encompasses 48 items composing the 5 subscales symptoms, functioning, emotionals, self-confidence and stigmatization. All scales range from 0-100, higher values indicate higher impairment.

he EORTC QLQ-C30 Aaronson is a self-report measure consisting of 30 items with a 4 point Likert Scale response format. It targets on functioning (physical, role emotional, cognitive, and social functioning and global health/QoL scale) and symptoms (fatigue, nausea and emesis, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties). All scales and single items range from 0-100.

The 23-item EORTC QLQ BR23 contains two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms. In addition, we include EORTC single items for hair loss.

It is a 10 items short instrument suitable for use in clinical trials. The BIS has a single sumscore; the response format is a 4-point Likert scale with high values indicating good body image.

The PRO-CTCAE allow the assessment of those symptoms listed in the CTCAE that can be perceived by a patient him/herself. For most items PRO-CTCAE assesses symptom severity, but for some it covers also symptom frequency and interference with daily activities. In total, this PRO instrument covers 81 symptoms with 126 items using a 5-point Likert scale for grading. For the purpose of this study, we use the PRO-CTCAE-ITEMS (Item Library Version 1.0; Version date: 3/24/2016) Symptom Term: Hair loss.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors	NCT04764357	Alopecia	Paxman Scalp Co... Alopecia Assess... Patient Reporte...	7 Years -	St. Jude Children's Research Hospital
Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy	NCT04117815	Breast Cancer F... Alopecia	Paxman Scalp Co... Alopecia Assess...	18 Years - 99 Years	Medical University Innsbruck
Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors	NCT04764357	Alopecia	Paxman Scalp Co... Alopecia Assess... Patient Reporte...	7 Years -	St. Jude Children's Research Hospital

Spots Global Cancer Trial Database for alopecia assessments