Portable Scalp Cooling System for the Improvement of Chemotherapy-Induced Hair Loss in Patients With Metastatic Breast Cancer

NCT05533320 | Withdrawn DMC FDA Device

• 3 other identifiers: 21030NCI-2022-06837P30CA033572
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial evaluates the benefits of a portable scalp cooling system (PSCS) for improving chemotherapy-induced hair loss in patients with breast cancer that has spread to other places in the body (metastatic) and are undergoing taxane-based chemotherapy. The PSCS is a new system designed to reduce chemotherapy induced hair loss. The PSCS is designed as a portable unit, allowing patients to leave the infusion center after chemotherapy is completed and finish scalp cooling at home. PSCS may help improve chemotherapy-induced hair loss in patients with metastatic breast cancer receiving chemotherapy.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Success in hair preservation

  Hair loss will be measured by the patient according to the Dean Score. (Grade 0: no hair loss, grade 1: \> 0 - 25%; grade 2: \> 25 - 50%; grade 3: \> 50 - 75%; grade 4: \> 75%). Hair preservation was defined as hair loss no more than grade 2.

  At 4 weeks after completion of the 6th chemotherapy cycle

Secondary Outcomes (5)

• Incidence of adverse events of PSCS

  At 4 weeks, 3 months, and 6 months following the conclusion of 6 cycles of chemotherapy

• Burden on nurses and infusion center team

  Up to 1 year

• Tolerability of PSCS

  Up to 1 year

• Hair loss recovery

  Up to 1 year

• Patients quality of life

  Up to 30 days after the last dose of treatment

Study Arms (1)

Supportive care (PSCS)

EXPERIMENTAL

Patients undergo scalp cooling using the PSCS 30 minutes before, during, and for up to 2 hours after completion of chemotherapy for 6 chemotherapy sessions.

Device: Cold Cap Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Cold Cap Therapy DEVICE

Undergo scalp cooling

Also known as: Cold Cap, Paxman Scalp Cooling System, PSCS, Scalp Cooling, Scalp Cryotherapy, Scalp Hypothermia

Supportive care (PSCS)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (PSCS)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (PSCS)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant
• Age: \>= 18 years
• Eastern Cooperative Oncology Group (ECOG) =\< 2
• Ability to read and understand English or Spanish for questionnaires
• Documented diagnosis of metastatic breast cancer with at least a 6 month life expectancy
• A planned course of taxane based chemotherapy in the metastatic setting, including paclitaxel, docetaxel or abraxane
• At least 6 months from the last chemotherapy causing hair loss with complete recovery of hair
• Willing to be contacted for brief annual assessments for five years
• Women of childbearing potential (WOCBP): negative urine pregnancy test
• Agreement by females of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study
• Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

You may not qualify if:

• Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss
• A history of whole brain radiation with persistent hair thinning or alopecia, or concurrent whole brain radiation therapy
• Exposure to other investigational agents, drugs, device or procedure that may cause hair loss
• Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
• Any cutaneous scalp metastases
• Clinically significant liver dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device
• Clinically significant renal dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device
• A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
• Evidence of untreated or poorly controlled hyper or hypothyroidism
• American Society of Anesthesiologist Class \>= 3
• Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• Pregnant or breastfeeding
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• James R Waisman

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: December 14, 2022
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-02