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Scalp Cooling for Chemotherapy-Induced Hair Loss

N/A
Recruiting
Led By Beth McLellan, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient will be starting >4 cycles of taxane-based chemotherapy treatment for curative intent after enrollment
Diagnosis of breast or non-small cell lung cancer (NSCLC) stage I-III
Must not have
Planned bone marrow ablation chemotherapy or skull irradiation
Past chemotherapy administration or administration of anthracyclines (doxorubicin)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 11 months (from the start to completion of chemotherapy)
Awards & highlights
No Placebo-Only Group

Summary

This trialis testing methods to improve scalp cooling efficacy in cancer patients with skin of color, to reduce chemotherapy-induced hair loss.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects may include discomfort from cold during treatment sessions due to scalp cooling devices and possible headaches. Long-term side effects will be studied as part of this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will start a chemotherapy treatment with taxane for more than 4 cycles.
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I have been diagnosed with early to mid-stage breast or lung cancer.
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I can take care of myself but may struggle with hard physical activities.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for intense chemotherapy or radiation therapy targeting my skull.
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I have previously received chemotherapy or drugs like doxorubicin.
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I have a history of migraines, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid issues, cold urticaria, cold agglutinin disease, or scalp metastases.
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I use hair weave/extensions and don't plan to remove them.
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I do not have any other types of cancer, including blood cancers.
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I have mild hair loss.
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I have been diagnosed with stage IV breast cancer or non-small cell lung cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 11 months (from the start to completion of chemotherapy)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 11 months (from the start to completion of chemotherapy) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient distress during treatment
Severity of chemotherapy-induced alopecia
Secondary study objectives
Patient distress after treatment
Severity of persistent chemotherapy-induced alopecia
Other study objectives
Pharmacotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Scalp cooling with hairstyleExperimental Treatment1 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 emulsionExperimental Treatment1 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 CoolingActive Control1 Intervention
Control with no scalp cooling

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
457 Previous Clinical Trials
588,591 Total Patients Enrolled
3 Trials studying Alopecia
10 Patients Enrolled for Alopecia
PaxmanUNKNOWN
2 Previous Clinical Trials
185 Total Patients Enrolled
2 Trials studying Alopecia
185 Patients Enrolled for Alopecia
Beth McLellan, MDPrincipal InvestigatorMontefiore Medical Center
1 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Scalp Cooling with Conditioner and Water Emulsion (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05213936 — N/A
Alopecia Research Study Groups: No Scalp Cooling, Scalp Cooling with conditioner and water emulsion, Scalp cooling with hairstyle
Alopecia Clinical Trial 2023: Scalp Cooling with Conditioner and Water Emulsion Highlights & Side Effects. Trial Name: NCT05213936 — N/A
Scalp Cooling with Conditioner and Water Emulsion (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05213936 — N/A
Alopecia Patient Testimony for trial: Trial Name: NCT05213936 — N/A
~1 spots leftby Jan 2025