Recruiting

Scalp Cooling

Sponsor:

Montefiore Medical Center

Code:

NCT05213936

Conditions

Alopecia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Scalp cooling with hairstyle

Scalp cooling with conditioner and water emulsion

Study Details

Brief summary:

The purpose of this study is to evaluate hairstyling techniques aimed at increasing efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia, determine scalp cooling effect on persistent chemotherapy-induced alopecia, and elucidate molecular mechanisms and predictive biomarkers associated with scalp cooling success in patients with skin of color receiving chemotherapy for breast or non-small cell lung cancer.

This study is being conducted because prior studies have found scalp cooling to be highly effective in preventing hair loss resulting from chemotherapy. However, minority representation was largely limited in completed trials. A recent study found that scalp cooling devices are less efficacious in patients with skin of color, likely because patients with skin of color have hair is predominantly types 3 (curly) and 4 (kinky), which tend to become bulkier when wet and can interfere with scalp cooling cap fitting. The investigators plan to test two techniques aimed at improving scalp cooling efficacy in patients with skin of color through hairstyling methods that minimize hair volume in order to increase cooling cap to scalp contact: 1) cornrows/braids/twists or 2) water/conditioner emulsion on hair. Preliminary data show that breast cancer patients with type 3 or 4 hair receiving taxane chemotherapy and scalp cooling using these techniques to prepare the hair for scalp cooling cap fitting all experienced hair preservation. Additionally, the investigators will also assess persistent chemotherapy-induced alopecia outcomes and incidence by following patients up to 6 months after completing treatment. Finally, specific gene expression changes in taxane-induced chemotherapy-induced alopecia in vitro have been described previously. The investigators will test the hypothesis that scalp cooling reverses such changes in chemotherapy-induced alopecia, assess for biomarkers predictive for scalp cooling success, and investigate persistent chemotherapy-induced alopecia molecular mechanisms using non-invasive transcriptome sequencing on plucked hair follicles.

Conditions

Alopecia

Study ID

NCT05213936

Start date

Oct 24, 2022

Status verified date

Jul, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age >= 18 years
2. Female
3. Hair type 3 (curly) or type 4 (kinky)
4. Diagnosis of breast cancer or non-small cell lung cancer (NSCLC) or gynecologic cancer stage I-IV
5. Patient will be starting >= 4 cycles of taxane-based chemotherapy treatment for curative intent after enrollment

a. Concurrent HER, cisplatin, cyclophosphamide therapies and doxorubicin therapies allowed
6. Eastern Cooperative Oncology Group (ECOG) 0-2: fully active, restrictive in physically strenuous activity, ambulatory and capable of self-care

Exclusion Criteria:

1. Hair type other than 3 or 4
2. Male
3. Use of hair weave or extensions without plans to remove
4. Concurrent malignancy including hematologic malignancies (i.e. leukemia or lymphoma)
5. Alopecia Common Terminology Criteria for Adverse Events > grade 1 at baseline
6. Past chemotherapy administration if past treatment was <= 10 years ago
7. History of migraines or cluster headaches, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid dysfunction, cold urticaria, cold agglutinin disease, scalp metastases
8. Planned bone marrow ablation chemotherapy or skull irradiation
9. Pregnant patient

Study Design

Enrollment

41 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Scalp cooling with hairstyle

Scalp cooling with hairstyle (braids, twists, cornrows) to minimize hair volume and increase scalp cooling cap to scalp contact

experimental: Scalp Cooling with conditioner and water emulsion

Scalp cooling after coating hair with conditioner and water emulsion to minimize hair volume and increase scalp cooling cap to scalp contact

no intervention: No Scalp Cooling

Control with no scalp cooling

Interventions

Scalp cooling with hairstyle

Hair will be prepared accordingly for the cooling cap fitting based on which approach the patient prefers: braids/cornrows/twists

Scalp cooling with conditioner and water emulsion

Hair will be prepared accordingly for the fitting based on which approach the patient prefers: or conditioner and water emulsion to coat the hair.

Primary outcome measure

  • Severity of chemotherapy-induced alopecia - hair count density [ Time Frame: 4 weeks after completion of chemotherapy, up to ~6 months total ]
  • Severity of chemotherapy-induced alopecia - adverse events [ Time Frame: 4 weeks after the completion of chemotherapy, up to ~6 months total ]

Central Contacts and Locations

Central contacts

Beth McLellan, MD

(718) 862-8840bmclella@montefiore.org

Yana Kost, BA

240-383-6896yana.kost@einsteinmed.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Warner Robinson, DMD

786-385-7775warrobinso@montefiore.org

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-07-16.