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临床试验/NCT03543020
NCT03543020终止不适用

Radiation- Induced Alopecia in Patients Undergoing Radiation Therapy to the Brain: A Prospective Clinical and Dosimetric Study of Primary and Metastatic Brain Tumour Patients

Fortis Memorial Research Institute1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
1
主要终点
To record the degree of alopecia at the conclusion of radiotherapy compared to pre- radiotherapy status with use of scalp sparing radiotherapy technique.

研究概览

简要总结

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

详细描述

Patients with primary or metastatic cancers to the brain need to undergo partial or whole brain radiotherapy. Alopecia is an inadvertent side effect of Radiation therapy to the brain. Much of this alopecia occurs in patches and is often associated with permanent loss of hair. Irradiation-induced epilation is due to high susceptibility of anagen follicles to radiation. Loss of hair can be stressful and distressing for cancer patients.

Various studies have tried to address the issue of threshold dose for radiotherapy induced alopecia. The severity and type of skin response and consequent alopecia to radiation is decided by multitude of factors - total dose and dose fractionation, quality of radiation, area or volume of tissue irradiated, anatomic site and vascular response. Studies have shown that 3Gy produces complete, reversible anagen alopecia and permanent alopecia begins to occur at 5Gy.

At higher dose rates the susceptibility of hair melanocytes is much more than epidermal melanocytes. Freysz et al in a retrospective analysis of 18 patients deduced that a cumulative dose as high as 12Gy results in alopecia that is reversible.Temporary alopecia is seen in most patients receiving WBRT with conventional fractionation. Most of these studies are either small reports or were done before the advent of modern technology. The advent of precision radiotherapy techniques has made it possible to utilize techniques that reduce the dose to the scalp in an attempt to minimize the chances of radiation- induced alopecia.

In a first, a phase II dosimetric and clinical study by De Puysseleyr et al concluded that Volumetric Modulated Arc Therapy (VMAT)- WBRT delivers lower scalp doses as compared to conventional parallel opposed fields but the study was closed prematurely as it failed to show any clinical benefit in terms of preventing alopecia. They however, concluded that the threshold Treatment Planning System (TPS) dose for temporary alopecia is around 10Gy in 5 fractions.

In a study by Ting et al alopecia was observed in half of the patients undergoing Whole Brain Radiotherapy (WBRT) to a dose of 30Gy/10 fractions did not have significant alopecia. The remaining half had mild alopecia. In the study by Mahadevan A et al, hippocampus sparing WBRT also spares hair follicle bearing regions of the scalp while maintaining strict compliance to hippocampus avoidance zone. There is no consensus regarding the threshold TPS dose for alopecia as the study of dose received by hair follicles during intensity modulated radiotherapy for whole brain is limited by lack of knowledge of dose-effect relation of temporary alopecia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients with Central Nervous System tumors (primary/metastatic) undergoing radiation to whole brain/ partial brain.
  • All techniques of radiotherapy used for treatment delivery including VMAT and IMRT.
  • Fractionation regimes- conventional and hypofractionation.
  • Patients with KPS> 70, Patients able to communicate regarding the treatment side-effects.
  • Eligible patients willing to be a part of the trial.
  • Patients undergoing radiotherapy with or without concurrent Temozolomide

排除标准

  • Patients who have received prior radiotherapy to scalp.
  • Patients that need to be treated for scalp lesion such as squamous cell carcinomas of scalp.
  • Poor neurological status performance patients who are unable to communicate.
  • Prior co-morbidities/ dermatological conditions predisposing to pre-existent excessive hair fall (including Systemic Lupus Erythematosus, Hypothyroidism, Polycystic Ovarian Disease and similar conditions)
  • Patients unwilling to come for follow-up.
  • Patients who are completely bald.

结局指标

主要结局

To record the degree of alopecia at the conclusion of radiotherapy compared to pre- radiotherapy status with use of scalp sparing radiotherapy technique.

时间窗: From starting treatment to 1 month follow up post RT completion;

To measure the alopecia at pre- RT, post RT completion and 1st follow up after 1 month of RT completion objectively using the SALT score.

次要结局

  • in vivo dosimetry values for scalp doses in modern radiotherapy treatment(first 5 days of radiation treatment)
  • radiation dose range levels that causes alopecia(at 21 months)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Dr. Meena Mishra

Attending Consultant, Department of Radiation Oncology

Fortis Memorial Research Institute

研究点 (1)

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