Clinical trial NCT04626895: Efficacy of Paxman Scalp Cooling to Prevent Chemo Induced Alopecia in Black Patients With Breast or GYN Cancers
Official title: Measuring the Efficacy of Paxman Scalp Cooling to Prevent Chemotherapy Induced Alopecia (CIA) in Black Patients With Stage I-III Breast or Gynecological Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Ovarian Cancer
Gynecologic Neoplasm
Endometrial Cancer
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Paxman
First posted: 2020-11-13
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will measure the efficacy of scalp cooling with the Paxman Scalp Cooling (PSC) device in a diverse patient population with success measured as prevention of more than 50% hair loss during chemotherapy. We propose that scalp cooling has distinct efficacy in participants with black or ethnic-minority hair types due to differences in textures, hair thickness. This study will examine the success rate of scalp cooling in black patients receiving chemotherapy for breast or gynecological cancer.

Detailed description: The primary objective is to measure the efficacy of the PSC device in preventing CIA in this diverse patient population with success measured as prevention of \>grade 2 alopecia by self-report using the modified Dean scale or the VAS scale in \>50% of participants using the intervention. We propose that scalp cooling has distinct efficacy in participants with black or ethnic-minority hair types due to differences in textures, hair thickness.

The study aims include delivery of scalp cooling at each chemotherapy cycle with measurements of CIA at assigned intervals using patient self-report measured by the modified Dean scale and the Visual Analog Scale (VAS) outlined below.

The secondary aims are provider assessments of alopecia as measured by the NCI grading scale of alopecia, adverse effects of scalp cooling procedures such as headaches, dizziness, and pain, reasons for refusal or drop-out of study intervention.

Psychosocial and quality-of- life (QOL) effects of CIA in study participants will be measured using patient reported outcomes. The EORTC QLQ-B45 and Chemotherapy-Induced-Alopecia-Distress Scale (CADS) will be administered at designated time intervals.

Eligibility criteria: Inclusion Criteria:

* Stage I-III breast cancer patients
* Stage I-III endometrial cancer patients
* Stage I-III ovarian cancer patients
* Self-identified as black: African, African-American, or Caribbean black are included . Patients of mixed race who identify as black are also included.
* Planned for \>4 cycles of chemotherapy in the neoadjuvant or adjuvant setting with curative intent
* At least one chemotherapy agent being a taxane.
* Ability to read and answer questions in English
* Ability to sign informed consent for themselves.
* Able to fit into one of available cap sizes

Exclusion Criteria:

* Metastatic cancer patients
* Patients who do not self-identify as black (see definition above)
* History of cryoglobulinemia or cold agglutin disease
* Prior chemotherapy
* Non-taxane chemotherapy regimens (anthracycline based chemotherapy regimens are eligible for breast cancer patients)
* Baseline alopecia
* Concurrent medications to prevent hair loss
* Cold urticaria and cold- induced anaphylaxis
* Unable to fit into an available cap size
* Adults unable to consent on their own will not be eligible
* Individuals unable to answer questionnaires in English will not be eligible.
* Pregnant women will not be permitted to enroll as the use of this device in pregnancy is not well studied
* Prisoners will not be included in this study.

Primary outcomes:
measure: Patient reported rate of alopecia rate of alopecia
timeFrame: During active chemotherapy and completion of study, an average of 6 months
Secondary outcomes:
measure: Psychosocial assessments of chemotherapy-induced alopecia
timeFrame: During active chemotherapy and completion of study, an average of 6 months
measure: Quality of life assessments of chemotherapy-induced alopecia
timeFrame: During active chemotherapy and completion of study, an average of 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Asma Dilawari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dilawari A, Gallagher C, Alintah P, Chitalia A, Tiwari S, Paxman R, Adams-Campbell L, Dash C. Does Scalp Cooling Have the Same Efficacy in Black Patients Receiving Chemotherapy for Breast Cancer? Oncologist. 2021 Apr;26(4):292-e548. doi: 10.1002/onco.13690. Epub 2021 Feb 17.