Breast CancerNCT04626895
Efficacy of Paxman Scalp Cooling to Prevent Chemo Induced Alopecia in Black Patients With Breast or GYN Cancers
A study testing Paxman Scalp Cooling Device in people with Breast Cancer and Ovarian Cancer, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Gynecologic Neoplasm
- What is being tested?
- Paxman Scalp Cooling Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2019to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Ability to read and answer questions in English
- Ability to sign informed consent for themselves.
- Able to fit into one of available cap sizes
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Measuring the Efficacy of Paxman Scalp Cooling to Prevent Chemotherapy Induced Alopecia (CIA) in Black Patients With Stage I-III Breast or Gynecological Cancers
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.
Read the detailed description
The primary objective is to measure the efficacy of the PSC device in preventing CIA in this diverse patient population with success measured as prevention of >grade 2 alopecia by self-report using the modified Dean scale or the VAS scale in >50% of participants using the intervention. We propose that scalp cooling has distinct efficacy in participants with black or ethnic-minority hair types due to differences in textures, hair thickness.
The study aims include delivery of scalp cooling at each chemotherapy cycle with measurements of CIA at assigned intervals using patient self-report measured by the modified Dean scale and the Visual Analog Scale (VAS) outlined below.
The secondary aims are provider assessments of alopecia as measured by the NCI grading scale of alopecia, adverse effects of scalp cooling procedures such as headaches, dizziness, and pain, reasons for refusal or drop-out of study intervention.
Psychosocial and quality-of- life (QOL) effects of CIA in study participants will be measured using patient reported outcomes. The EORTC QLQ-B45 and Chemotherapy-Induced-Alopecia-Distress Scale (CADS) will be administered at designated time intervals.
- Being tested
- Paxman Scalp Cooling Device
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Genital Neoplasms, Female, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paxman Scalp Cooling DeviceDevice
Paxman scalp cooling device
| Study group | Role | What they receive |
|---|---|---|
| Scalp Cooling | Other | Patients who be will using the scalp cooling device during chemotherapy will be enrolled in tis arm Receives: Device: Paxman Scalp Cooling Device |
| Non Scalp-Cooling | No intervention | Patients who do not use scalp cooling device during chemotherapy will be enrolled in this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported rate of alopecia rate of alopecia
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
Measured: During active chemotherapy and completion of study, an average of 6 months
Secondary outcomes (2)
Psychosocial assessments of chemotherapy-induced alopecia
Psychosocial assessments of chemotherapy-induced alopecia will be measured by validated CADS (Chemotherapy-induced Alopecia Distress Scale) at designated time intervals. The questionnaire is composed of a 4-point likert Scale and 4 multi-items distress domain that include Physical (2 questions), Emotional (6 questions), Activity (6 questions) and Relationship (1 question). A score of 4 for each domain indicates greater distress. A score of 1 represents no distress.
Measured: During active chemotherapy and completion of study, an average of 6 months
Quality of life assessments of chemotherapy-induced alopecia
Quality of life assessments of chemotherapy-induced alopecia will be measured by EORTC QLQ BR45 questionnaire at designated time intervals. Higher score (4 for each question) is worse.
Measured: During active chemotherapy and completion of study, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start4 Jun 2019
- Primary completion31 Aug 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Paxman
- Responsible party
- Principal investigator, Asma Dilawari, Medstar Health Research Institute
- Investigators
- Asma Dilawari, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626895
- Sponsor's protocol ID
- STUDY00000334
- Status last verified
- Nov 2020
- First submitted
- 28 Oct 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code will be shared.
Publications
Dilawari 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.
PubMed 33512741
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Efficacy of Paxman Scalp Cooling to Prevent Chemotherapy Induced Alopecia (CIA) in Black Patients With Stage I-III Breast or Gynecological Cancers
- ClinicalTrials.gov ID
- NCT04626895
- Acronym / sponsor ID
- STUDY00000334
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Paxman
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective is to measure the efficacy of the PSC device in preventing CIA in this diverse patient population with success measured as prevention of >grade 2 alopecia by self-report using the modified Dean scale or the VAS scale in >50% of participants using the intervention. We propose that scalp cooling has distinct efficacy in participants with black or ethnic-minority hair types due to differences in textures, hair thickness.
The study aims include delivery of scalp cooling at each chemotherapy cycle with measurements of CIA at assigned intervals using patient self-report measured by the modified Dean scale and the Visual Analog Scale (VAS) outlined below.
The secondary aims are provider assessments of alopecia as measured by the NCI grading scale of alopecia, adverse effects of scalp cooling procedures such as headaches, dizziness, and pain, reasons for refusal or drop-out of study intervention.
Psychosocial and quality-of- life (QOL) effects of CIA in study participants will be measured using patient reported outcomes. The EORTC QLQ-B45 and Chemotherapy-Induced-Alopecia-Distress Scale (CADS) will be administered at designated time intervals.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scalp Cooling | Other | Device: Paxman Scalp Cooling DevicePatients who be will using the scalp cooling device during chemotherapy will be enrolled in tis arm |
| Non Scalp-Cooling | No intervention | –Patients who do not use scalp cooling device during chemotherapy will be enrolled in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paxman Scalp Cooling DevicePaxman scalp cooling device | Device | Scalp Cooling |
Primary outcome
Patient reported rate of alopecia rate of alopecia
Time frame: During active chemotherapy and completion of study, an average of 6 months
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
2 secondary outcomes
Psychosocial assessments of chemotherapy-induced alopecia
Time frame: During active chemotherapy and completion of study, an average of 6 months
Quality of life assessments of chemotherapy-induced alopecia
Time frame: During active chemotherapy and completion of study, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 33512741Dilawari 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.
- Individual participant dataSharing planned: Yes. Study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asma Dilawari, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paxman Scalp Cooling Device in people with Breast Cancer and Ovarian Cancer, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported rate of alopecia rate of alopecia (time frame: During active chemotherapy and completion of study, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04626895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.