PAXMAN Orbis Scalp Cooler for Alopecia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
USOncology / Texas Oncology-Memorial City, Houston, TX
Alopecia+2 More
PAXMAN Orbis Scalp Cooler - Device
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a hair loss prevention system is safe and effective in reducing chemotherapy-induced alopecia in women with breast cancer.

See full description

Eligible Conditions

  • Alopecia
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether PAXMAN Orbis Scalp Cooler will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Alopecia. Measurement will happen over the course of 4 to 8 Months.

4 to 8 Months
Hair Preservation
Improved Quality of Life
5 years
Time to First Recurrence and Overall Survival

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

PAXMAN Orbis Scalp Cooler
1 of 1
Experimental Treatment

This trial requires 236 total participants across 1 different treatment group

This trial involves a single treatment. PAXMAN Orbis Scalp Cooler is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

PAXMAN Orbis Scalp Cooler
Device
Scalp Cooling

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Closest Location

USOncology / Texas Oncology-Memorial City - Houston, TX

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A new study has found that breast cancer stage 1-2 can be accurately diagnosed by a blood test show original
Chemotherapy needs to be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy treatments. show original
If the patient has a history of diabetes, the Hemoglobin A1c must be drawn within 3 months prior to treatment and found to be within normal limits. show original
The following are possible regimens for the treatment of breast cancer: Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2, Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2, Doxorubicin 50mg/m2 with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2, Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent, Docetaxel 100mg/m2 as a single agent, Docetaxel 75mg/m2-100mg/m2 with pertuzumab and traztuzumab at standard doses, Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2, Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses. show original
People who want to be treated with thyroid hormone therapy must have their TSH levels checked within the last year and have them within the normal range. show original
The CBC and CMP should be done at least 4 weeks before starting treatment, and they should be within acceptable limits. show original
in patients who have received prior therapy with pertuzumab Patients who have received prior therapy with pertuzumab are allowed to receive concurrent pertuzumab at standard doses. show original
The administration of chemotherapy on a dose dense schedule is allowed as clinically indicated show original
prior to surgery for early-stage breast cancer Individuals with early-stage breast cancer may consider undergoing neoadjuvant or adjuvant chemotherapy with curative intent prior to surgery show original
in pregnant women A pregnant woman can take concurrent traztuzumab doses at the standard recommended levels. show original

Patient Q&A Section

What causes alopecia?

"There is not enough evidence available on which to base a conclusion about why a male develops baldness. A combination of genetic, hormonal and environmental factors may combine to make a man bald or not. A number of genes have been identified as being likely candidates but none of them have yet been confirmed. HLA genes have also been implicated as being of importance. It would not be possible for us to know for certain if androgens are the cause.\n" - Anonymous Online Contributor

Unverified Answer

How many people get alopecia a year in the United States?

"About 1.3 million U.S. children between the ages of 2–17 get Alopecia. Also one in 18 men gets Alopecia and a high proportion of baldness is reported to be caused by poor health." - Anonymous Online Contributor

Unverified Answer

What is alopecia?

"Among the many kinds of hair removal used by people, there are shampoos, lotions, sprays, shampoos, and combs that each help to remove particular types of hair. In shampoos, the active ingredient is often sodium lauryl sulfate (SLS)—a surfactant that combines with the keratin and sebum in the hair to form lather (soap) and helps to loosen the hair shaft; the main cosmetic ingredient in shampoos is the sodium or ammonium lauroyl sulfate (LAS), which works by binding the keratin and sebum on the hair." - Anonymous Online Contributor

Unverified Answer

What are the signs of alopecia?

"Alopecia is a rarity complication of chemotherapy. If alopecia develops, other causes are also considered. Many patients have self-described alopecia as a side effect of chemotherapy.\n" - Anonymous Online Contributor

Unverified Answer

Can alopecia be cured?

"Although many people in early to mid-adulthood develop reversible hair loss, most people do not experience a major symptom change in their hairstyles. Older adult cohorts might be more vulnerable." - Anonymous Online Contributor

Unverified Answer

What are common treatments for alopecia?

"There are many different methods that may be used to treat hair loss. Although there are several types of hair loss, some can also be reversed with more specialized treatments.\n" - Anonymous Online Contributor

Unverified Answer

Is paxman orbis scalp cooler safe for people?

"The method used in this study in patients with bilateral alopecia and normal head geometry is technically easy, safe, and provides a consistent temperature alteration. An increase in scalp skin temperature in the affected scalp seems to be achievable with local thermal energy sources." - Anonymous Online Contributor

Unverified Answer

How does paxman orbis scalp cooler work?

"Data from a recent study suggests that application warmed to skin or hair should be avoided. The cooling effect of the warmer or cool water only applies to the scalp skin or hair." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets alopecia?

"The age of an individual with androgenic alopecia typically falls between 50 and 75 years of age; this is comparable to the average age of onset of androgenic alopecia in individuals with other hair-associated disorders, i.e., age at onset with female pattern hair loss in women and age at onset with hair color alterations in men." - Anonymous Online Contributor

Unverified Answer

Is paxman orbis scalp cooler typically used in combination with any other treatments?

"We have demonstrated that combining paxman orbis scalp with any other treatment, in addition to having a positive effect on folliculitis, also increases hair growth." - Anonymous Online Contributor

Unverified Answer

What is paxman orbis scalp cooler?

"Results from a recent clinical trial shows no difference in the mean skin temperature between the paxman eye cream and saline drops over 12 hr in adults. This is reassuring as it will reassure patients about the cosmetic results of paxman or other similar herbal creams. We conclude topical application of paxman, which is a herbal cream and therefore not a drug will not be effective for cooling scalp or eyelids in this population of patients. The study also finds that the mean corneal temperature was higher when patients used paxman (9ºC) as compared to saline (8ºC) by 1ºC. It is therefore recommended that paxman or other similar herbal creams be only used with care at the lowest possible tolerable skin temperature." - Anonymous Online Contributor

Unverified Answer

Has paxman orbis scalp cooler proven to be more effective than a placebo?

"The treatment of scalp cooler with paxman orbis scalp has not shown any benefits over a placebo. Therefore, if cooling is of benefit treatment must be tailored to suit a patient’s individual clinical condition." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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