Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigating the Efficacy of Hair Sparing Radiotherapy Treatment to the Whole Brain. (SPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02213536
Recruitment Status : Terminated (Poor recruitment and follow up)
First Posted : August 11, 2014
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Lynsey RICE, HCA International Limited

Tracking Information
First Submitted Date August 8, 2014
First Posted Date August 11, 2014
Last Update Posted Date February 22, 2019
Study Start Date August 2015
Actual Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2015)
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 ]
Original Primary Outcome Measures
 (submitted: August 8, 2014)
Evaluate the feasibility of using Volumetric Modulated Arc Therapy (VMAT) method of radiotherapy delivery designed to reduce radiation dose to the hair follicles [ Time Frame: 6 months post radiotherapy treatment ]
Change History Complete list of historical versions of study NCT02213536 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 16, 2015)
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 ]
Original Secondary Outcome Measures
 (submitted: August 8, 2014)
  • To measure the rate and amount of hair loss [ Time Frame: 6 months post radiotherapy treatment end ]
  • Measure the rate and coverage of regrowth [ Time Frame: 6 months post radiotherapy treatment end. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigating the Efficacy of Hair Sparing Radiotherapy Treatment to the Whole Brain.
Official Title Investigating the Efficacy of Scalp Sparing Radiotherapy Treatment to the Whole Brain: Examining the Effect of Hair Loss and Re-growth
Brief 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.

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;

1) 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:

  1. Objective assessment: Photographic
  2. 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with a positive cancer diagnosis requiring whole brain radiotherapy with a life expectancy greater than 4 months.
Condition Metastatic Brain Cancer
Intervention Radiation: VMAT (Volumetric Modulated Arc Therapy)
Delivering a prescribed radiation dose to the whole brain using VMAT to reduce dose to hair follicles on scalp.
Other Names:
  • Radiation Therapy
  • Radiation Oncology
Study Groups/Cohorts VMAT WBRT
Patients requiring whole brain radiotherapy as part of their cancer managment.
Intervention: Radiation: VMAT (Volumetric Modulated Arc Therapy)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: February 20, 2019)
5
Original Estimated Enrollment
 (submitted: August 8, 2014)
20
Actual Study Completion Date February 20, 2019
Actual Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previous whole brain radiotherapy
  • Pregnant females
  • Unable to give informed consent
  • Urgent cases that need same or next day treatment when referred
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02213536
Other Study ID Numbers HCA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lynsey RICE, HCA International Limited
Study Sponsor HCA International Limited
Collaborators Not Provided
Investigators
Study Chair: David Landau, DR Clinical Oncologist with practising privilages at The Harley Street Clinic, HCA International Limited hospitals.
PRS Account HCA International Limited
Verification Date February 2019