Clinical trial · Interventional
Efficacy of Paxman Scalp Cooling to Prevent Chemo Induced Alopecia in Black Patients With Breast or GYN Cancers
Measuring the Efficacy of Paxman Scalp Cooling to Prevent Chemotherapy Induced Alopecia (CIA) in Black Patients With Stage I-III Breast or Gynecological Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will measure the efficacy of scalp cooling with the Paxman Scalp Cooling (PSC) device in a diverse patient population with success measured as prevention of more than 50% hair loss during chemotherapy. We propose that scalp cooling has distinct efficacy in participants with black or ethnic-minority hair types due to differences in textures, hair thickness. This study will examine the success rate of scalp cooling in black patients receiving chemotherapy for breast or gynecological cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gynecologic Neoplasm | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paxman Scalp Cooling Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Scalp Cooling
- description
- Patients who be will using the scalp cooling device during chemotherapy will be enrolled in tis arm
- interventionNames
- Device: Paxman Scalp Cooling Device
- type
- NO_INTERVENTION
- label
- Non Scalp-Cooling
- description
- Patients who do not use scalp cooling device during chemotherapy will be enrolled in this arm.
Primary outcomes (1)
- measure
- Patient reported rate of alopecia rate of alopecia
- timeFrame
- During active chemotherapy and completion of study, an average of 6 months
- description
- Patient-reported rate of alopecia as measured by the modified Dean Scale and VAS. Hair preservation is defined in this scale as \<50% hair loss (\< grade 2) or score of \<50 on VAS
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage I-III breast cancer patients * Stage I-III endometrial cancer patients * Stage I-III ovarian cancer patients * Self-identified as black: African, African-American, or Caribbean black are included . Patients of mixed race who identify as black are also included. * Planned for \>4 cycles of chemotherapy in the neoadjuvant or adjuvant setting with curative intent * At least one chemotherapy agent being a taxane. * Ability to read and answer questions in English * Ability to sign informed consent for themselves. * Able to fit into one of available cap sizes Exclusion Criteria: * Metastatic cancer patients * Patients who do not self-identify as black (see definition above) * History of cryoglobulinemia or cold agglutin disease * Prior chemotherapy * Non-taxane chemotherapy regimens (anthracycline based chemotherapy regimens are eligible for breast cancer patients) * Baseline alopecia * Concurrent medications to prevent hair loss * Cold urticaria and cold- induced anaphylaxis * Unable to fit into an available cap size * Adults unable to consent on their own will not be eligible * Individuals unable to answer questionnaires in English will not be eligible. * Pregnant women will not be permitted to enroll as the use of this device in pregnancy is not well studied * Prisoners will not be included in this study.
References
Publications (1)
- DERIVEDDilawari A, Gallagher C, Alintah P, Chitalia A, Tiwari S, Paxman R, Adams-Campbell L, Dash C. Does Scalp Cooling Have the Same Efficacy in Black Patients Receiving Chemotherapy for Breast Cancer? Oncologist. 2021 Apr;26(4):292-e548. doi: 10.1002/onco.13690. Epub 2021 Feb 17. PMID 33512741