AlopeciaNCT02935569
Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy
A study testing Compression HeadBand in people with Alopecia, run by Michael Milano, MD,PhD at 1 site in United States.
Trial summary
This study hypothesizes that in patients undergoing whole brain radiotherapy, a compression headband will decrease the percentage of patients with significant hair loss following radiation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alopecia
- What is being tested?
- Compression HeadBand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 2014
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years old.
- Undergoing whole brain radiation therapy, using lateral opposed fields
- Total planned radiation prescription dose between 30 Gy and 37.5 Gy in 10 to 15 treatments.
Who cannot join
- Current complete or near-complete alopecia (natural or chemotherapy-induced)
- Concurrent or sequential chemotherapy with an agent known to commonly cause alopecia (Adriamycin, Cytoxan, Ifosfamide, Taxol (greater than 50 mg/m2), or Vincristine).
- Previous Radiation to the Scalp
- Any active dermatologic disease affecting the scalp, or temporal arteritis
- History of severe headaches.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept. of Radiation Oncology, University of Rochester, Med Center
Rochester, New York, 14642
About this study
Official title: Feasibility Clinical Study of Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy
This study hypothesizes that in patients undergoing whole brain radiotherapy, a compression headband will decrease the percentage of patients with significant hair loss following radiation.
Read the detailed description
This is a pilot feasibility study. The primary objective of this study is to seek preliminary information to answer the following question:
- Does a compression headband, placed only at the time of irradiation, reduce the incidence of significant hair loss after whole brain radiation, as compared to historical controls? This study will also seek to answer these secondary questions:
- Is a temporary compression headband well tolerated in patients undergoing whole brain radiation?
- If a portion of patients do have significant hair loss after radiation in spite of compression banding, what is the timing of hair regrowth?
- In normal volunteers, does a compression headband cause acute hypoxia in the scalp, as measured by a transcutaneous oxygen pressure monitor, and, if so, to what degree?
- Conditions
- Alopecia
- Being tested
- Compression HeadBand
- Keywords
- Alopecia, Radiotherapy
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression HeadBandDevice
- commercially available office rubber bands (Alliance® Sterling Rubber Bands, Size 105) OR commercially available medical non-latex bands (Allegience® 1" x 18" x .025") with Velcro adhesion
- Plastics disks, hollow (3.5 cm diameter, by 1 cm height)
Two bands will be placed just behind the ears laterally, and over the occipital protuberance posteriorly. The plastic inserts will be placed in the temporal fossae bilaterally, under the band to provide adequate tension on the temporal artery.
| Study group | Role | What they receive |
|---|---|---|
| Compression Headband | Experimental | a compression headband, placed only at the time of irradiation Receives: Device: Compression HeadBand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hair loss defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3
The primary outcome of this study will be the presence of "significant hair loss" by 6 weeks after the completion of whole brain radiation. This will be defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3.
The amount of hair loss will be evaluated at the following time points.
- Before whole brain radiation
- six weeks following radiation
Measured: baseline to 6 weeks
Secondary outcomes (3)
Temporary compression headband side effects (Nausea, Headache, Redness, Tingling) in patients undergoing whole brain radiation
Does a temporary compression headband cause side effects in patients undergoing whole brain ? Nausea? Headache? Redness? Tingling?
Measured: 6 weeks
Timing of hair regrowth
If a portion of patients do have significant hair loss after radiation in spite of compression banding, what is the timing of hair regrowth?
Measured: one year
Acute hypoxia in the scalp of normal volunteers caused by compression headband (if present, to what degree?) as measured by a transcutaneous oxygen pressure monitor
In normal volunteers, does a compression headband cause acute hypoxia in the scalp, as measured by a transcutaneous oxygen pressure monitor, and, if so, to what degree?
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startMay 2012
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Results with 4 subjects suggest a redesign of Compression system is required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Milano, MD,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Milano, MD,PhD, University of Rochester
- Investigators
- Michael Milano, MD, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935569
- Sponsor's protocol ID
- UCCP12009
- Status last verified
- Feb 2017
- First submitted
- 12 Oct 2012
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers can contact the PI to obtain IPD with collaboration.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Clinical Study of Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy
- ClinicalTrials.gov ID
- NCT02935569
- Acronym / sponsor ID
- UCCP12009
- Conditions
- Alopecia
- Keywords
- Alopecia, Radiotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results with 4 subjects suggest a redesign of Compression system is required.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Michael Milano, MD,PhDUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Oct 2016 (estimated)
- 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 hypothesizes that in patients undergoing whole brain radiotherapy, a compression headband will decrease the percentage of patients with significant hair loss following radiation.
Detailed description
This is a pilot feasibility study. The primary objective of this study is to seek preliminary information to answer the following question:
- Does a compression headband, placed only at the time of irradiation, reduce the incidence of significant hair loss after whole brain radiation, as compared to historical controls? This study will also seek to answer these secondary questions:
- Is a temporary compression headband well tolerated in patients undergoing whole brain radiation?
- If a portion of patients do have significant hair loss after radiation in spite of compression banding, what is the timing of hair regrowth?
- In normal volunteers, does a compression headband cause acute hypoxia in the scalp, as measured by a transcutaneous oxygen pressure monitor, and, if so, to what degree?
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compression Headband | Experimental | Device: Compression HeadBanda compression headband, placed only at the time of irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years old.
- Undergoing whole brain radiation therapy, using lateral opposed fields
- Total planned radiation prescription dose between 30 Gy and 37.5 Gy in 10 to 15 treatments.
Key exclusion criteria (5 listed)
- Current complete or near-complete alopecia (natural or chemotherapy-induced)
- Concurrent or sequential chemotherapy with an agent known to commonly cause alopecia (Adriamycin, Cytoxan, Ifosfamide, Taxol (greater than 50 mg/m2), or Vincristine).
- Previous Radiation to the Scalp
- Any active dermatologic disease affecting the scalp, or temporal arteritis
- History of severe headaches.
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 |
|---|---|---|
| Compression HeadBand* commercially available office rubber bands (Alliance® Sterling Rubber Bands, Size 105) OR commercially available medical non-latex bands (Allegience® 1" x 18" x .025") with Velcro adhesion * Plastics disks, hollow (3.5 cm diameter, by 1 cm height) Two bands will be placed just behind the ears laterally, and over the occipital protuberance posteriorly. The plastic inserts will be placed in the temporal fossae bilaterally, under the band to provide adequate tension on the temporal artery. | Device | Compression Headband |
Primary outcome
Change in Hair loss defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3
Time frame: baseline to 6 weeks
The primary outcome of this study will be the presence of "significant hair loss" by 6 weeks after the completion of whole brain radiation. This will be defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3. The amount of hair loss will be evaluated at the following time points. * Before whole brain radiation * six weeks following radiation
3 secondary outcomes
Temporary compression headband side effects (Nausea, Headache, Redness, Tingling) in patients undergoing whole brain radiation
Time frame: 6 weeks
Timing of hair regrowth
Time frame: one year
Acute hypoxia in the scalp of normal volunteers caused by compression headband (if present, to what degree?) as measured by a transcutaneous oxygen pressure monitor
Time frame: 1 hour
Results and safety
The study was stopped early (reason given: Results with 4 subjects suggest a redesign of Compression system is required.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Individual participant dataSharing planned: Yes. Researchers can contact the PI to obtain IPD with collaboration.
Related trials for Alopecia
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
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.
Michael Milano, MD, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression HeadBand in people with Alopecia, run by Michael Milano, MD,PhD 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 28 Feb 2017. 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 was stopped early (reason given: Results with 4 subjects suggest a redesign of Compression system is required.). Results are not available in the source record.
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?
Change in Hair loss defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3 (time frame: baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2017.