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

PAXMAN Orbis Scalp Cooler

Control No treatment

Julie Nangia, M.D.

Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.

Cooling the scalp during chemotherapy may help reduce the chances of losing hair during treatment. The investigators are hoping that using the PAXMAN Orbis Scalp Cooling Device may stop patients who are undergoing chemotherapy from losing their hair.

One blinded observer assesses the patient outcome

Scalp Cooling to Prevent Chemo-induced Hair Loss

Scalp Cooling for Alopecia Prevention (SCALP)

Patients are aware of whether or not they are using the cooling device and can tell if they have hair loss.

Improved quality of life as a result of reduced hair loss is a primary motivator for developing the Paxman Scalp Cooling device. Quality of life will be assessed at baseline and 2-3 weeks after each course of chemotherapy. Three widely used and validated scales will be used: the EORTC QLQ C-30, HADS and BIS. Subjects will be evaluated at multiple time points and data will be analyzed using descriptive methods with median and inter quartile rang to assess the effect of treatment group and alopecia status on functioning, quality of life and depression.

The primary efficacy endpoint will be success in hair preservation, defined as CTCAE v 4 alopecia grade \<2, and will be assessed by a healthcare professional who is blinded to study treatment.

A safety follow-up for safety data will be done yearly for 5 years looking at time to first recurrence of breast cancer, overall survival, site of first recurrence, and incidence of isolated scalp metastasis. This will be collected during routine clinical observation

Julie Nangia

Assistant Professor

Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses.

No adverse event from non-cooling subjects since they did not use the device so they were not at risk.

Scalp Cooling

PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap

Scalp Cooling

Control

Control No Treatment: No treatment to prevent hair loss

Non-cooling

Control

Control No treatment: No treatment to prevent hair loss

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Tao Wang

Randomized patients who underwent at least one cycle of chemotherapy were evaluable for efficacy. 27 patients in the cooling group and 25 patients in the non-cooling group did not start chemotherapy or discontinued during the 1st cycle were excluded from the efficacy analysis.

Hair Preservation

Time to First Recurrence and Overall Survival

Improved Quality of Life

Control No Treatment

Overall Study

Facies

Keratosis, Actinic

Keratosis

Precancerous Conditions

Ingenol Mebutate 0.015%

Mark Lebwohl, MD

Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet radiation exposure. While most authorities consider AK as a pre-malignant lesion, some consider it as an incipient squamous cell carcinoma (SCC). Among the current therapies for the treatment of AK are excisional surgery, cryosurgery, electrodesiccation and curettage, topical chemotherapy and light therapies. Cryosurgery is considered the gold standard for therapy, however as with other lesion-directed therapies, cryosurgery does not treat subclinical lesions in the surrounding skin. Ingenol mebutate is the active compound in the sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment has been approved for the treatment of AKs. The goal of AK therapy for all physicians is to provide an effective, tissue-sparing treatment with good cosmetic results. Ingenol mebutate gel 0.015% has shown to not only have a high clearance rate but also a transient localized inflammatory skin response that resolves quickly without sequelae. However, one common fear about ingenol mebutate is that it's mechanism of action is purely destructive to both AKs and healthy skin, and that retreatment would produce an equally, if not more, caustic result on the skin such as severe erosion, scaling, and erythema. It is our hope to debunk this misconception and demonstrate that reapplication of a second cycle of ingenol mebutate would result in lower LSR scores compared to the LSR in the first cycle of application. We plan to treat 20 subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a 25 cm2 treatment area on the face or scalp. All subjects will be treated with two cycles of ingenol mebutate 0.015%. The first cycle will be started on Day 1, and the second cycle will be started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days regimen for both cycles.

We plan to treat 20 subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a 25 cm2 treatment area on the face or scalp. All subjects will be treated with two cycles of ingenol mebutate 0.015%. The first cycle will be started on Day 1, and the second cycle will be started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days regimen for both cycles. For the first cycle of study application, subjects will be followed on day 1, day 2, and day 4 during treatment; on day 1 baseline photographs will be taken, on day 2 LSR will be assessed and visual analog scale (VAS) regarding perceived irritation will be conducted, and on day 4 LSR, VAS and photographs will be taken. Post-treatment follow-up will be conducted on day 8 and day 15, in which LSR will be assessed and photographs taken. Approximately four weeks later, a second cycle of once daily for three day regimen of ingenol mebutate 0.015% will be applied to the same treatment area on the face or scalp. Subjects will be followed during treatment on day 29, day 30 and day 32; on day 29 LSR and photographs will be taken, on day 30 LSR will be assessed and VAS conducted, and on day 32 LSR, VAS and photographs will be taken. Post-treatment follow-up for the second cycle of application will occur on day 36, day 43, and day 56. During these post-treatment follow-up visits LSR and photographs will be taken. LSR scores from day 4 and day 32 will be assessed by a blinded observer. Lastly, on day 29 and day 56 the patient's treatment satisfaction will be evaluated on a 10 point visual analog scale (VAS). Consequently, there will be a total of 11 visits during a 56 day period.

Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp

An Investigator-Initiated Study to Assess the Degree of Irritation After a Second Cycle of Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp

To evaluate the degree of irritation, as measured by local skin reactions (LSR), after a second cycle of ingenol mebutate gel to the face or scalp through photography assessed by a blinded observer.

To evaluate and compare the degree of irritation, as measured by LSR, that occurs one (1) day post-application of the first and second cycle of ingenol mebutate gel to the face or scalp.

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
Scalp Cooling to Prevent Chemo-induced Hair Loss	NCT01986140	Breast Cancer Alopecia	PAXMAN Orbis Sc... Control No trea...	18 Years -	Baylor Breast Care Center
Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp	NCT01836367	Actinic Keratos...	Ingenol Mebutat...	18 Years -	Icahn School of Medicine at Mount Sinai
Scalp Cooling to Prevent Chemo-induced Hair Loss	NCT01986140	Breast Cancer Alopecia	PAXMAN Orbis Sc... Control No trea...	18 Years -	Baylor Breast Care Center
Scalp Cooling to Prevent Chemo-induced Hair Loss	NCT01986140	Breast Cancer Alopecia	PAXMAN Orbis Sc... Control No trea...	18 Years -	Baylor Breast Care Center
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 scalp

Every month we try and update this database with for scalp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for scalp

Every month we try and update this database with for scalp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for scalp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.