Scalp Cooling for Chemotherapy-Induced Hair Loss

Recruiting at 1 trial location

Overseen By Beth McLellan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must be taking: Taxane chemotherapy

Disqualifiers: Male, Other hair types, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve scalp cooling to prevent hair loss during chemotherapy in individuals with curly or kinky hair, specifically those with breast or non-small cell lung cancer. Researchers are testing whether styling techniques like braids or a conditioner and water mix can help the cooling cap fit better and work more effectively. They are also examining if these methods can prevent long-term hair loss and identifying gene changes linked to hair loss. This trial suits women starting taxane-based chemotherapy who have type 3 or 4 hair. As an unphased trial, it offers a unique opportunity to contribute to innovative solutions for hair preservation during chemotherapy.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does allow for certain concurrent therapies like HER, cisplatin, cyclophosphamide, and doxorubicin.

What prior data suggests that these hairstyling techniques for scalp cooling are safe?

Research shows that scalp cooling effectively prevents hair loss from chemotherapy. Studies have found that these systems, which cool the scalp to protect hair during treatment, are generally well-tolerated by patients. One study noted that many patients experienced less than 50% hair loss when using a scalp cooling system during certain types of chemotherapy.

Scalp cooling is the only FDA-approved method to prevent hair loss from chemotherapy, indicating it has passed strict safety tests. Another study with 74 patients confirmed that this cooling method is both effective and safe.

In this trial, researchers are testing two hairstyling techniques: using conditioner and water or specific hairstyles. These methods aim to improve the cooling cap's fit on the scalp, especially for people with curly or kinky hair, which can be harder to fit under the cap.

Overall, existing research supports the safety of scalp cooling for chemotherapy patients. This trial seeks to enhance its effectiveness for people with different hair types. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these scalp cooling techniques because they offer unique approaches to reducing chemotherapy-induced hair loss. Unlike standard treatments that might not prevent hair loss, these methods aim to enhance the effectiveness of scalp cooling caps. One method uses a conditioner and water emulsion to improve cap contact, while the other incorporates hairstyles like braids or cornrows for the same purpose. By maximizing contact between the cooling cap and the scalp, these techniques could potentially offer better protection against hair loss during chemotherapy, giving patients an innovative option to maintain their hair.

What evidence suggests that these hairstyling techniques could improve the effectiveness of scalp cooling for chemotherapy-induced hair loss?

Studies have shown that cooling the scalp can effectively prevent hair loss during chemotherapy. For patients with solid tumors, it is the most effective method available. One study found that 85.7% of participants kept a significant amount of their hair with scalp cooling. However, standard scalp cooling is less effective for patients with curly or kinky hair, often seen in people with darker skin tones. This trial will compare different scalp cooling methods. One arm will use hairstyling techniques like braids to improve cap fit, while another arm will apply a mix of conditioner and water for the same purpose. Early data indicate that these methods help maintain hair volume in patients with darker skin undergoing taxane chemotherapy. ^{1 4 5 6 7}

Who Is on the Research Team?

Beth McLellan, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with breast or non-small cell lung cancer at stages I-III, starting taxane-based chemo. It's specifically for those with curly (type 3) or kinky (type 4) hair who are generally active and can care for themselves. Excluded are individuals with other cancers, certain health conditions like severe anemia or diabetes, a history of migraines, scalp metastases, past specific chemotherapy treatments, or advanced-stage IV cancer.

Inclusion Criteria

I will start a chemotherapy treatment with taxane for more than 4 cycles.

I have been diagnosed with early to mid-stage breast or lung cancer.

I am currently on HER, cisplatin, and cyclophosphamide treatments.

Exclusion Criteria

I am scheduled for intense chemotherapy or radiation therapy targeting my skull.

I have previously received chemotherapy or drugs like doxorubicin.

I have a history of migraines, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid issues, cold urticaria, cold agglutinin disease, or scalp metastases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy and Scalp Cooling Treatment

Participants receive chemotherapy with scalp cooling using hairstyling techniques to improve efficacy

Up to 5 months

Regular visits during chemotherapy sessions

Follow-up

Participants are monitored for persistent chemotherapy-induced alopecia and other outcomes

6 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Scalp Cooling with Conditioner and Water Emulsion
• Scalp Cooling with Hairstyle

Trial Overview The study tests two hairstyling techniques to improve the effectiveness of scalp cooling in preventing hair loss from chemotherapy in patients of color: one using braids/cornrows/twists and another using water/conditioner emulsion. The goal is to enhance cap-to-scalp contact and assess long-term effects on hair preservation up to six months post-treatment.

How Is the Trial Designed?

Group I: Scalp cooling with hairstyle Experimental Treatment 1 Intervention

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

Group II: Scalp Cooling with conditioner and water emulsion Experimental Treatment 1 Intervention

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

Group III: No Scalp Cooling Active Control 1 Intervention

Control with no scalp cooling

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Paxman

Collaborator

Trials

3

Recruited

220+

Published Research Related to This Trial

In a study of 83 breast cancer patients undergoing (neo-)adjuvant chemotherapy, scalp cooling achieved a mean success rate of 52.6% in preventing hair loss, with over half of the patients (51.7%) not requiring head covers.

Patient satisfaction with the scalp cooling system was high, with satisfaction scores ranging from 70 to 80 on a scale of 0 to 100, indicating that this method is effective in helping patients retain their hair during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful reduction of alopecia induced by anthracycline and taxane containing adjuvant chemotherapy in breast cancer - clinical evaluation of sensor-controlled scalp cooling. Friedrichs, K., Carstensen, MH.[2022]

In a study of 117 Japanese female breast cancer patients, those who completed scalp cooling during chemotherapy (Group A) experienced significantly better hair recovery and less persistent alopecia compared to those who discontinued scalp cooling (Group B).

Patients in Group A showed faster hair recovery and lower grades of alopecia at multiple time points (1, 4, and 7 months after chemotherapy), indicating that scalp cooling is an effective method for mitigating hair loss during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of hair recovery after (neo)adjuvant chemotherapy with scalp cooling in Japanese breast cancer patients. Ohsumi, S., Kiyoto, S., Takahashi, M., et al.[2021]

In a study of 55 women undergoing various chemotherapy regimens, 78% successfully used a sensor-controlled scalp cooling system (DigniCap) to prevent hair loss, with younger patients and those receiving specific drug combinations experiencing less alopecia.

The effectiveness of scalp cooling varied significantly by chemotherapy regimen and patient age, with younger women (50 years and younger) showing a 43% success rate in preventing hair loss compared to only 10% in older women under similar treatment conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensor-controlled scalp cooling to prevent chemotherapy-induced alopecia in female cancer patients. Fehr, MK., Welter, J., Sell, W., et al.[2019]

Scalp cooling is an effective method to prevent chemotherapy-induced hair loss in patients with solid tumors, and recent studies show it does not increase the risk of scalp metastasis.

Advancements in scalp cooling technology and reduced cooling times may enhance its adoption in clinical practice, alongside ongoing research into the genetic factors related to hair loss during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of scalp cooling for chemotherapy-induced hair loss. Young, A., Arif, A.[2021]

A study involving 17 Australian women with breast cancer revealed that patient perceptions of scalp cooling during chemotherapy significantly influenced their treatment decisions and expectations regarding hair loss.

Participants expressed a desire for accurate information about the efficacy and tolerability of scalp cooling, as well as hair care guidance, to help them make informed choices about their treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scalp cooling: a qualitative study to assess the perceptions and experiences of Australian patients with breast cancer. Shaw, J., Baylock, B., O'Reilly, A., et al.[2018]

Scalp cooling using the DigniCap™ device was effective in preserving hair for gynecological oncology patients receiving weekly Paclitaxel, with 66.7% of patients losing less than 50% of their hair based on self-assessment.

In contrast, patients receiving conventional Paclitaxel every three weeks did not experience significant hair preservation, highlighting the potential efficacy of scalp cooling in specific chemotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scalp cooling for reducing alopecia in gynecology oncology patients treated with dose-dense chemotherapy: A pilot project. Mitric, C., How, B., Matanes, E., et al.[2022]

In a study involving 46 breast cancer patients undergoing chemotherapy, the use of a scalp cooling device significantly reduced chemotherapy-induced hair loss, with 59% of patients reporting hair loss of less than grade 2 after treatment.

The device was well tolerated by 81.5% of patients, although there was a discrepancy in hair loss perception, with operators reporting higher hair retention (78%) compared to patient self-assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair Loss Prevention by a Scalp Cooling Device in Early Breast Cancer Patients: The Poliambulanza Preliminary Experience. Prochilo, T., Huscher, A., Andreis, F., et al.[2019]

Scalp cooling is currently the only FDA-cleared and safe method to prevent chemotherapy-induced alopecia (CIA), with about a 50% chance of patients maintaining enough hair to avoid needing a wig during treatment.

The review highlights the importance of understanding how to effectively deliver scalp cooling, as improvements in its application could significantly reduce the psychological distress associated with hair loss during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Clinical and Biological Guide for Understanding Chemotherapy-Induced Alopecia and Its Prevention. Dunnill, CJ., Al-Tameemi, W., Collett, A., et al.[2019]

Scalp cooling has been used since the 1970s as a method to prevent hair loss caused by chemotherapy, which is a common and distressing side effect for cancer patients.

The article discusses the varying opinions and controversies surrounding scalp cooling, highlighting the need for further research and recommendations to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is wrong with the 30-year-old practice of scalp cooling for the prevention of chemotherapy-induced hair loss? Breed, WP.[2008]

In a study of 48 Japanese breast cancer patients undergoing chemotherapy, the use of a scalp-cooling device significantly reduced the incidence of alopecia, with 26.7% of patients experiencing no hair loss compared to 0% in the control group.

The scalp-cooling device also facilitated faster recovery of hair volume after chemotherapy, with 85.7% of patients in the scalp-cooling group seeing a ≥50% increase in hair volume within 12 weeks, compared to 50% in the control group, and no serious adverse events were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Scalp Cooling in Preventing and Recovering From Chemotherapy-Induced Alopecia in Breast Cancer Patients: The HOPE Study. Kinoshita, T., Nakayama, T., Fukuma, E., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-alopecia-5-2022-04a49

Scalp Cooling for Chemotherapy-Induced Hair Loss Additionally, a study found that scalp cooling led to faster hair volume recovery after chemotherapy, with 85.7% of patients experiencing significant hair ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10137043/

Prevention and Treatment of Chemotherapy-Induced ... Presently, scalp cooling is the most effective strategy to prevent CIA for patients with solid tumors undergoing certain chemotherapy regimen.

3. clinicaltrial.be clinicaltrial.be/en/details/178533?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Scalp Cooling for Chemotherapy-Induced Alopecia in ... This study is being conducted because prior studies have found scalp cooling to be highly effective in preventing hair loss resulting from ...

4. meddermsociety.org meddermsociety.org/content/uploads/2024/03/Warber-Robinson-DDS-Scalp-Cooling-for-Chemotherapy-Induced-Alopecia-in-Patients-of-Color-An-Ongoing-Clinical-Trial.pdf

Scalp Cooling for Chemotherapy-Induced Alopecia in ... Prior studies have found scalp cooling (SC) to be highly effective in preventing CIA. However, minority representation was largely limited in completed trials.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38843479/

Scalp Cooling in Preventing Persistent Chemotherapy ... Conclusion: Scalp cooling reduced the incidence of PCIA, primarily by increasing hair thickness compared with control. Scalp cooling is helpful ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7563013/

Scalp cooling to prevent chemotherapy-induced alopecia Scalp hypothermia to prevent chemotherapy-induced alopecia is effective and safe: a pilot study of a new digitized scalp-cooling system used in 74 patients.

7. paxmanscalpcooling.com paxmanscalpcooling.com/wp-content/uploads/2025/04/Paxman-Scalp-Cooling-Guide_Training-Manual_US-DIGITAL.pdf

Scalp Cooling Guide Chemotherapy-induced alopecia is considered: • The most feared side effect of treatment for more than 75% of patients. • The most traumatic side effect of ...