Clinical trial · Interventional
Portable Scalp Cooling System for the Improvement of Chemotherapy-Induced Hair Loss in Patients With Metastatic Breast Cancer
Evaluation Of Benefits of The Portable Scalp Cooling System (PSCS) in Metastatic Breast Cancer Patients on Taxane-Based Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI decided to withdraw
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage IV Breast Cancer AJCC v8 | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cold Cap Therapy | Device | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (PSCS)
- description
- 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.
- interventionNames
- Device: Cold Cap Therapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Success in hair preservation
- timeFrame
- At 4 weeks after completion of the 6th chemotherapy cycle
- description
- 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.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available