MedTrace Logo

Radiation- Induced Alopecia in Patients Undergoing Radiation Therapy to the Brain

NCT03543020 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2019-03-04

No results posted yet for this study

Summary

Study will be conducted on patients receiving Whole brain(WB) / Partial Brain(PB) radiotherapy using volumetric modulated arc therapy or intensity modulated radiotherapy at Department of Radiation Oncology, Fortis Memorial Research Insititute, Gurgaon, Haryana with end points. 1) Primary - To observe degree of alopecia at conclusion of radiotherapy compared to pre- radiotherapy status using scalp sparing radiotherapy technique. 2) Secondary 1)Recording the temporal dose levels causing radiation associated alopecia and dose range acceptable for reversible radiation-induced alopecia and determine dose volume threshold for the same 2)Recording of scalp doses by in vivo dosimetry and correlation with radiation induced alopecia Methods: Study includes 50 patients of partial / whole brain radiation therapy to be followed consecutively for radiation- induced alopecia. Contouring: For WB radiation entire scalp will be contoured. For PB irradiation contouring of partial scalp to be done by drawing 2-3 cm beyond the PTV edge in all directions. Planning: The treatment planning and delivery to be done as per existing practice in department. Contouring at Monaco / Brain Lab Contouring stations and planning on Monaco Treatment planning system (TPS) Version 5.11.01. Duration: 18 months for patient accrual; in this observational study patients undergoing radiation therapy to brain will be evaluated clinically and objectively for degree of alopecia. Photographic and Clinical record of four views of scalp- Right lateral, Left lateral, top and rear to be taken at intervals- a)Pre-Radiotherapy (RT) b) RT Conclusion c) First follow-up at 1 month. Hair loss quantified using Severity of Alopecia Tool (SALT) Score. Dosimetric measurements having subcomponents - measurement of surface dose uses optically stimulated luminescence dosimeters to be placed over scalp for first 5 fractions in case of conventional or fractionated SRT, for the entire duration of short course treatments and for first 5 fractions in case of palliative whole brain radiation given over 10 fractions. TPS measurements: Average, maximum dose and dose per unit volume will be reported for whole and partial scalp. Outcomes 1. Quantify the degree of alopecia at the conclusion of radiotherapy as compared to pre- radiotherapy status. 2. To record the radiation dose levels causing alopecia. 3. Obtain in vivo dosimetry values for scalp doses in modern radiotherapy treatment

Conditions

  • Alopecia; X-Rays

Interventions

RADIATION

radiation therapy to brain

OSL placed over the scalp for initial 5 fractions for patients undergoing partial/ whole brain radiation therapy

Sponsors & Collaborators

  • Fortis Memorial Research Institute

    lead INDUSTRY

Principal Investigators

  • Meena Mishra, M.D. · Fortis Memorial Research Institute, Gurgaon, Haryana, India

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-17
Primary Completion
2018-12-31
Completion
2019-01-30

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03543020 on ClinicalTrials.gov