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

Breast Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Estrogens

HER2-positive (HER2+) and Estrogen receptor-positive (ER+) breast cancer patients undergoing adjuvant chemotherapy including trastuzumab.

HER2-negative breast cancer patients (HER2-) and Estrogen receptor-positive (ER+) breast cancer patients undergoing adjuvant chemotherapy without trastuzumab.

Both groups recieve standard care as decided by the responsible clinicians at the department of Oncology. The course of the treatment is completely independent from the observations in the present study.

None (Observational study)

Tora Ida Henriksen, MSc., Ph.D.

Laura Thomsen, MSc.

Søren Nielsen, MSc., Ph.D.

The objective of this observational study is to investigate the significance of the HER2 receptor for brown fat activity in humans. Our preliminary data clearly demonstrates that the ErbB signaling pathway, which includes the HER2 receptor, strongly promotes development and function of cultured human BAT cells. The HER2 receptor is a part of the ErbB signaling pathway, and antibodies against thee HER2 receptor are a part of the standard treatment for HER2-positive breast cancer. Therefore, the hypothesis is that the activity of brown fat will be reduced in patients treated with HER2 blocking antibody compared to patients who are not treated with HER2 blocking antibody. The present study simply takes advantage of the treatment protocol to explore the contribution of the HER2 receptor in the development of brown adipose tissue in humans. Participants will complete two testing days, one before and one after their treatment period of approx. one year. On the testing days, identification of brown fat activity will be performed using cooling and infrared thermography. In addition, resting metabolic rate and a glucose tolerance test will be performed. Since presence of active brown adipose tissue in humans is inversely related to obesity, total and visceral fat mass, plasma glucose levels, presence of cardiovascular disease and diabetes status, it is of great importance to investigate the molecular mechanisms for development of brown fat tissue and may lead to discovery of novel strategies to counteract obesity and obesity related disorders.

BACKGROUND:

Breast cancer is the most common cancer among women worldwide, and with increasing survival rates focus on long-term adverse effects of treatment has increased. Weight gain is well documented and common occurrence for many breast cancer patients. Recently, a review reported that 50-96% of women experience weight gain during treatment. Furthermore, many patients report a progressive weight gain in the months and years after treatment and patients rarely return to their pre-diagnosis weight. Moreover, weight gain in breast cancer patients has been linked to a poor prognosis compared to patients without weight gain, and to obesity-related disorders including metabolic syndrome.

Adipose tissue is one of the largest human organs. Two functionally distinct types of adipose tissue exist: white adipose tissue and brown adipose tissue (BAT). While BAT was long thought to be present only in rodents and human infants, it is now clear that active BAT also exists in varying degrees in adult humans. Activated BAT has great capacity for energy consumption and takes up large amounts of blood lipids and glucose to use in thermogenesis, and the presence of active BAT in humans is inversely related to obesity, total and visceral fat mass, plasma glucose levels, presence of cardiovascular disease and diabetes status. In accordance, acute cooling increases energy expenditure compared to thermoneutral conditions and correlates with higher BAT activity. Finding ways to activate BAT in humans is thus an attractive approach to prevent weight gain and ensuing comorbidities.

Human epidermal growth factor receptor 2 (HER2) positive breast cancer accounts for \~15 % of breast cancer cases, and direct inhibition of the HER2 receptor (also called the ErbB2 receptor) is used as standard treatment of HER2-positive breast cancer.

Our preliminary data clearly demonstrates that the ErbB signaling pathway, which includes the HER2 receptor, strongly promotes development and function of cultured human BAT cells and mouse brown adipose tissue. A potential secondary effect of the HER2 receptor blockade used in cancer treatment, is the binding of these inhibitors to ErbB2 receptors in the adipose tissue subsequently affecting downstream signaling pathways that might influence the activity of brown adipose tissue and thereby whole-body metabolism. In support of this hypothesis, weight gain during chemotherapy in HER2-positive breast cancer patients is associated with a decrease in the activity of brown adipose tissue.

Since BAT activity has been suggested as a target to limit weight gain and metabolic disorders, it is of great importance to understand the molecular mechanisms behind BAT recruitment and function in humans. This study will provide insight into the contribution of the HER2 receptor in the development of brown adipose tissue in humans and may thus lead to discovery of novel strategies to counteract obesity and obesity related disorders in breast cancer survivors as well as in the general population.

STUDY SET-UP

Against this background, a prospective cohort study will be performed at the Centre for Physical Activity (CFAS), and the Department of Oncology, both located at Rigshospitalet, Copenhagen, Denmark. A total of 30 patients will be recruited. This includes patients with breast cancer HER2+/ Estrogen receptor (ER)+ treated with the recombinant monoclonal anti-neoplastic antibody combination trastuzumab (n = 15) and BMI and age-matched HER2-/ER+ patients with breast cancer, who are not treated with ErbB2/HER2 receptor blockage, will be used as a control group (n = 15). The treatment is planned and initiated according to standard of care and for clinical reasons. The present study simply takes advantage of the treatment protocol to explore a physiological mechanism, hence participation in the study does not affect the treatment regimen. After cessation of the study period subjects will continue their treatment as prescribed by the oncologists prior to study enrolment.

Patients included in the study will undergo two identical test days; one prior to the treatment and one by the end of the treatment. The study does not include any additional interventions, restrictions, or investigations during the treatment period. For each testing day, the participants will be assessed for body composition (DXA scan) and anthropometrics. This will be followed by a cooling protocol to activate the brown adipose tissue. BAT activity will be measured by infrared thermography. Furthermore, participants will undergo measurements of resting metabolic rate, an oral glucose tolerance (OGTT) test and blood samples.

Provided that the patient fulfilled the inclusion criterion concerning cold activated BAT (see inclusion criteria), they will be invited to a second test day after adjuvant treatment. This test day will be similar to the first, i.e., including anthropometric measurements, a DXA scan, blood samples, an OGTT, indirect calorimetry measurements, a cooling intervention and IRT assessment of BAT activity.

AIM

The objective of this project is thus to investigate the effects of HER2 blockade on human brown adipose tissue activity in HER2+ breast cancer patients as well as associated metabolic parameters.

Secondarily, the study aim to investigate whether a decrease in BAT activity is associated with weight gain or increased fat mass (as assessed by DXA-scan), decreased metabolic rate and changes in metabolic parameters including glycemic control in patients treated with HER2 blocking antibodies.

HYPOTHESIS

The hypothesis is that the activity of brown fat will be reduced in patients treated with HER2 blocking antibody trastuzumab for 17 series amounting to approx. one year of treatment compared to patients who are not treated with trastuzumab.

We will draw blood samples, but not for genetic analysis

The Effects of HER2 Receptor Signaling on Human Brown Fat Activity

The Effects of HER2 Receptor Signaling on Human Brown Fat Activity: A 1-year Prospective Cohort Study in Trastuzumab-treated Breast Cancer Patients Versus HER2 Negative Controls

Difference in cold-induced BAT activity between HER2+ breast cancer patients and HER2- breast cancer controls measured with infrared thermography (temperature difference).

Difference in weight (kilograms) between the HER2+ positive subjects and the HER2 negative controls

Difference in fat mass (kilograms) between the HER2+ positive subjects and the HER2 negative controls

Difference in resting- and cold induced energy expenditure (calories/day) between the HER2+ positive subjects and the HER2 negative controls, by measuring oxygen consumption (VO2) and carbon dioxide production (VCO2) (Indirect calorimetry).

Difference in cold induced energy expenditure (calories/day) between the HER2+ positive subjects and the HER2 negative controls, by measuring oxygen consumption (VO2) and carbon dioxide production (VCO2) (Indirect calorimetry).

Difference in glycemic control between the HER2+ positive subjects and the HER2 negative controls. Examined by an Oral Glucose Tolerance Test measuring insulin (pmol/L)

Difference in glycemic control between the HER2+ positive subjects and the HER2 negative controls. Examined by an Oral Glucose Tolerance Test measuring glucose (mmol/L).

Difference in glycemic control between the HER2+ positive subjects and the HER2 negative controls. Examined by an Oral Glucose Tolerance Test measuring C-peptide (nmol/L).

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
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
The Effects of HER2 Receptor Signaling on Human Brown Fat Activity	NCT06222957	Breast Cancer	None (Observati...	18 Years -	Rigshospitalet, Denmark
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 cooling

Every month we try and update this database with for cooling 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 cooling

Every month we try and update this database with for cooling 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 cooling 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.