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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 11 months (from the start to completion of chemotherapy)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 currently on HER, cisplatin, and cyclophosphamide treatments.
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I am older than 18 years.

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

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

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
440 Previous Clinical Trials
581,581 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: Scalp cooling with hairstyle, Scalp Cooling with conditioner and water emulsion, No Scalp Cooling
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there remaining vacancies in this trial for participants?

"Accurate. The data hosted on clinicaltrials.gov indicates that recruitment for this medical experiment is currently in progress, with the initial posting having taken place on October 24th 2022 and an edit to its specifications taking place just recently on December 22nd 2022."

Answered by AI

What is the magnitude of participants in this clinical exploration?

"Affirmative. Information on clinicaltrials.gov shows that the medical trial is currently enrolling participants, with the initial listing posted on October 24th 2022 and last updated December 22nd 2022. The study requires 30 individuals to be recruited from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
Montefiore Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I want to see if this would help my condition and want to be active in helping to find cures.
PatientReceived 1 prior treatment
~10 spots leftby Jan 2025