Metastatic Brain CancerSPARENCT02213536
Investigating the Efficacy of Hair Sparing Radiotherapy Treatment to the Whole Brain.
An observational study of Metastatic Brain Cancer, run by HCA International Limited at 1 site in United Kingdom.
Trial summary
To investigate the use of a scalp sparing technique of radiotherapy treatment designed to treat the whole brain. Current treatment methods to treat the whole brain with radiotherapy result in complete alopecia as a side effect. Hair loss is usually patchy and uneven and re-growth similar and slow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Brain Cancer
- What is being tested?
- VMAT (Volumetric Modulated Arc Therapy)
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to 20 Feb 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a positive cancer diagnosis requiring whole brain radiotherapy with a life expectancy greater than 4 months.
Who may be able to join
- Adults over 18
- Positive cancer diagnosis
- Either proven brain metastasis or prophylaxis for primary lung cancer
- Have no epilating chemotherapy planned
- Basic understanding of English
Who cannot join
- Previous whole brain radiotherapy
- Pregnant females
- Unable to give informed consent
- Urgent cases that need same or next day treatment when referred
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Efficacy of Scalp Sparing Radiotherapy Treatment to the Whole Brain: Examining the Effect of Hair Loss and Re-growth
To investigate the use of a scalp sparing technique of radiotherapy treatment designed to treat the whole brain. Current treatment methods to treat the whole brain with radiotherapy result in complete alopecia as a side effect. Hair loss is usually patchy and uneven and re-growth similar and slow.
It is hoped that reducing the radiation dose to the hair bearing follicle on the scalp will reduce hair loss and increase the speed and evenness of re-growth.
Read the detailed description
Rationale for conducting the SPARE study:
The purpose of this study is to evaluate the effect of delivering WBRT via the VMAT method on hair loss and subsequent re-growth. Hair loss has been found to have a negative impact on QoL and can be particularly stressful for patients with a very short life expectancy, this is already well documented. Trying to minimise this treatment side effect, as previously stated in the literature, is a worthwhile investigation. This study is not looking at any prescribed dose changes to the established, evidence based and well documented prescriptions for WBRT. SPARE is an observational study of hair loss and re-growth during and after a patient's prescribed clinical treatment.
Aims and Objectives;
- To observe hair loss and re-growth in patients undergoing Whole Brain Radiotherapy using the Volumetric Modulated Arc Therapy method of delivery.
As complete alopecia is expected in 100% of patients receiving conventionally delivered WBRT it will be considered a positive result if complete hair loss does not happen when using VMAT in this group of patients.
Assessment of hair loss and re-growth.
The assessment of hair loss and subsequent re-growth will be conducted using both objective and subjective assessments:
- Objective assessment: Photographic
- Subjective assessment: Patient interviews \ completion of a hair record sheet.
Photographic assessment:
Initial baseline photographs will be taken before any radiotherapy treatment is delivered on day one of the treatment schedule. Four photographs in total of the head, two laterals (left and right sides), the top (superior) and back (posterior). Subsequent serial photographs will be taken at two weeks, one, two, three, and four months after radiotherapy treatment.
Subjective assessment:
Patients will be asked to give their own opinion on their hair loss \ gain and this will be recorded on the hair record forms and completed by a member of the study team. This will be conducted at the same time intervals as the scalp photographs being taken.
Scalp photos will also be assessed by 2 independent members of the research team and scored using the same scales as the participant. Subsequent follow-up scalp pictures will be assessed against baseline (day 1) photos or complete alopecia images to assess re-growth.
Planning and Dosimetry:
Treatment plans will be generated using a 2 arc VMAT technique generated on Varian's Eclipse treatment planning system using 10 MV photons delivered on a Varian Clinac equipped with a Millennium Multileaf Collimator. Plans will be optimized selecting a maximum dose rate of 600 MU/min.
- Conditions
- Metastatic Brain Cancer
- Being tested
- VMAT (Volumetric Modulated Arc Therapy)
- Keywords
- Metastatic brain cancer, Whole brain radiotherapy, Scalp sparing whole brain radiotherapy, Prophylactic whole brain radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMAT (Volumetric Modulated Arc Therapy)Radiation
Also called Radiation Therapy, Radiation Oncology
Delivering a prescribed radiation dose to the whole brain using VMAT to reduce dose to hair follicles on scalp.
| Study group | Role | What they receive |
|---|---|---|
| VMAT WBRT | Patients requiring whole brain radiotherapy as part of their cancer managment. Receives: Radiation: VMAT (Volumetric Modulated Arc Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess hair loss and hair regrowth in patients undergoing WBRT using VMAT via photographic assessment by independent professionals at intervals up to 16 weeks post end of treatment.
Measured: 4 months post radiotherapy treatment
Secondary outcomes (1)
To assess patient perceptions of hair loss and hair regrowth in patients undergoing WBRT using VMAT via self assessment at intervals up to 16 weeks post end of treatment.
Measured: 4 months post radiotherapy treatment end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startAug 2015
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
Why it stopped: Poor recruitment and follow up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Brain 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- HCA International Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynsey RICE, HCA International Limited
- Investigators
- David Landau, DR, Study chair, Clinical Oncologist with practising privilages at The Harley Street Clinic, HCA International Limited hospitals.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213536
- Sponsor's protocol ID
- HCA
- Acronym
- SPARE
- Status last verified
- Feb 2019
- First submitted
- 8 Aug 2014
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Scalp Sparing Radiotherapy Treatment to the Whole Brain: Examining the Effect of Hair Loss and Re-growth
- ClinicalTrials.gov ID
- NCT02213536
- Acronym / sponsor ID
- SPARE / HCA
- Conditions
- Metastatic Brain Cancer
- Keywords
- Metastatic brain cancer, Whole brain radiotherapy, Scalp sparing whole brain radiotherapy, Prophylactic whole brain radiotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruitment and follow up
- Enrolment
- 5 participants (actual)
- Lead sponsor
- HCA International LimitedUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 11 Aug 2014 (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.
To investigate the use of a scalp sparing technique of radiotherapy treatment designed to treat the whole brain. Current treatment methods to treat the whole brain with radiotherapy result in complete alopecia as a side effect. Hair loss is usually patchy and uneven and re-growth similar and slow.
It is hoped that reducing the radiation dose to the hair bearing follicle on the scalp will reduce hair loss and increase the speed and evenness of re-growth.
Detailed description
Rationale for conducting the SPARE study:
The purpose of this study is to evaluate the effect of delivering WBRT via the VMAT method on hair loss and subsequent re-growth. Hair loss has been found to have a negative impact on QoL and can be particularly stressful for patients with a very short life expectancy, this is already well documented. Trying to minimise this treatment side effect, as previously stated in the literature, is a worthwhile investigation. This study is not looking at any prescribed dose changes to the established, evidence based and well documented prescriptions for WBRT. SPARE is an observational study of hair loss and re-growth during and after a patient's prescribed clinical treatment.
Aims and Objectives;
- To observe hair loss and re-growth in patients undergoing Whole Brain Radiotherapy using the Volumetric Modulated Arc Therapy method of delivery.
As complete alopecia is expected in 100% of patients receiving conventionally delivered WBRT it will be considered a positive result if complete hair loss does not happen when using VMAT in this group of patients.
Assessment of hair loss and re-growth.
The assessment of hair loss and subsequent re-growth will be conducted using both objective and subjective assessments:
- Objective assessment: Photographic
- Subjective assessment: Patient interviews \ completion of a hair record sheet.
Photographic assessment:
Initial baseline photographs will be taken before any radiotherapy treatment is delivered on day one of the treatment schedule. Four photographs in total of the head, two laterals (left and right sides), the top (superior) and back (posterior). Subsequent serial photographs will be taken at two weeks, one, two, three, and four months after radiotherapy treatment.
Subjective assessment:
Patients will be asked to give their own opinion on their hair loss \ gain and this will be recorded on the hair record forms and completed by a member of the study team. This will be conducted at the same time intervals as the scalp photographs being taken.
Scalp photos will also be assessed by 2 independent members of the research team and scored using the same scales as the participant. Subsequent follow-up scalp pictures will be assessed against baseline (day 1) photos or complete alopecia images to assess re-growth.
Planning and Dosimetry:
Treatment plans will be generated using a 2 arc VMAT technique generated on Varian's Eclipse treatment planning system using 10 MV photons delivered on a Varian Clinac equipped with a Millennium Multileaf Collimator. Plans will be optimized selecting a maximum dose rate of 600 MU/min.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VMAT WBRT | – | Radiation: VMAT (Volumetric Modulated Arc Therapy)Patients requiring whole brain radiotherapy as part of their cancer managment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a positive cancer diagnosis requiring whole brain radiotherapy with a life expectancy greater than 4 months.
Key inclusion criteria (5 listed)
- Adults over 18
- Positive cancer diagnosis
- Either proven brain metastasis or prophylaxis for primary lung cancer
- Have no epilating chemotherapy planned
- Basic understanding of English
Key exclusion criteria (4 listed)
- Previous whole brain radiotherapy
- Pregnant females
- Unable to give informed consent
- Urgent cases that need same or next day treatment when referred
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 |
|---|---|---|
| VMAT (Volumetric Modulated Arc Therapy)Also: Radiation Therapy, Radiation OncologyDelivering a prescribed radiation dose to the whole brain using VMAT to reduce dose to hair follicles on scalp. | Radiation | VMAT WBRT |
Primary outcome
To assess hair loss and hair regrowth in patients undergoing WBRT using VMAT via photographic assessment by independent professionals at intervals up to 16 weeks post end of treatment.
Time frame: 4 months post radiotherapy treatment
1 secondary outcome
To assess patient perceptions of hair loss and hair regrowth in patients undergoing WBRT using VMAT via self assessment at intervals up to 16 weeks post end of treatment.
Time frame: 4 months post radiotherapy treatment end
Results and safety
The study was stopped early (reason given: Poor recruitment and follow up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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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.
David Landau, DR study chair
Clinical Oncologist with practising privilages at The Harley Street Clinic, HCA International Limited hospitals.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Brain Cancer, run by HCA International Limited at 1 site in United Kingdom.
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 5 inclusion and 4 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 22 Feb 2019. 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 Kingdom. 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: Poor recruitment and follow up). 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?
To assess hair loss and hair regrowth in patients undergoing WBRT using VMAT via photographic assessment by independent professionals at intervals up to 16 weeks post end of treatment. (time frame: 4 months post radiotherapy treatment). 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 22 Feb 2019.