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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 11 months (from the start to completion of chemotherapy)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 11 months (from the start to completion of chemotherapy)
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
456 Previous Clinical Trials
588,440 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
Eligibility Criteria:
This trial includes the following eligibility 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 scheduled for intense chemotherapy or radiation therapy targeting my skull.I am currently on HER, cisplatin, and cyclophosphamide treatments.I can take care of myself but may struggle with hard physical activities.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.I use hair weave/extensions and don't plan to remove them.I do not have any other types of cancer, including blood cancers.I am currently on HER, cisplatin, and cyclophosphamide treatments.Your hair type is not curly or tightly curled.I have mild hair loss.I am older than 18 years.Criterion: Your hair is curly or kinky.I have been diagnosed with stage IV breast cancer or non-small cell lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: No Scalp Cooling
- Group 2: Scalp Cooling with conditioner and water emulsion
- Group 3: Scalp cooling with hairstyle
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alopecia Patient Testimony for trial: Trial Name: NCT05213936 — N/A
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