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

NCT02213536 | Terminated

• 1 other identifier: HCA
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Brain Cancer

Keywords

Metastatic brain cancer; Whole brain radiotherapy; Scalp sparing whole brain radiotherapy; Prophylactic whole brain radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  4 months post radiotherapy treatment end

Study Arms (1)

VMAT WBRT

Patients requiring whole brain radiotherapy as part of their cancer managment.

Radiation: VMAT (Volumetric Modulated Arc Therapy)

Interventions

VMAT (Volumetric Modulated Arc Therapy) RADIATION

Delivering a prescribed radiation dose to the whole brain using VMAT to reduce dose to hair follicles on scalp.

Also known as: Radiation Therapy, Radiation Oncology

VMAT WBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Previous whole brain radiotherapy
• Pregnant females
• Unable to give informed consent
• Urgent cases that need same or next day treatment when referred

Sponsors & Collaborators

• HCA International Limited: lead

Study Sites (1)

The Harley Street Clinic

London, W1G 8PP, United Kingdom

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Therapeutics; Physical Phenomena

Study Officials

• David Landau, DR

  Clinical Oncologist with practising privilages at The Harley Street Clinic, HCA International Limited hospitals.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and Development radiographer

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 11, 2014
• Study Start: August 1, 2015
• Primary Completion: February 20, 2019
• Study Completion: February 20, 2019
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

GB (1)