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

NCT ID: NCT05533320

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2023-11-14

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.

Detailed Description

PRIMARY OBJECTIVE:

I. Measure efficacy of scalp cooling for patients undergoing taxane based chemotherapy for metastatic breast cancer.

SECONDARY OBJECTIVES:

I. Assess safety of PSCS in treating patients with metastatic breast cancer. II. Assess burden on nurses and infusion center team of patients using the PSCS.

III. Assess tolerability of PSCS. IV. Assess hair loss and recovery as assessed by the patient. V. Assess patient quality of life and satisfaction with treatment.

OUTLINE:

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.

After completion of study, patients are followed up for 1 year.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (PSCS)

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.

Group Type: EXPERIMENTAL

Cold Cap Therapy

Intervention Type: DEVICE

Undergo scalp cooling

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Cold Cap Therapy

Undergo scalp cooling

Intervention Type: DEVICE

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Cold Cap; Paxman Scalp Cooling System; PSCS; Scalp Cooling; Scalp Cryotherapy; Scalp Hypothermia; Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James R Waisman

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Other Identifiers

NCI-2022-06837

Identifier Type: REGISTRY

Identifier Source: secondary_id

21030

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21030

Identifier Type: -

Identifier Source: org_study_id