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临床试验/NCT04738227
NCT04738227已完成不适用

Effect of Low-level Laser Therapy on Salivary Flow, pH and Quality of Life in Irradiated Oropharyngeal Cancer Patients.

Ziauddin University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Increase in Quality of Life questionnaire Score

研究概览

简要总结

There are multiple treatment modalities for head and neck cancer. They include radiation therapy, chemotherapy and surgery. Radiation therapy aims to control the tumor with minimum damage to adjacent tissues. Surgery is the preferred treatment for accessible cancers. Radiation and/or chemotherapy is used as an adjunct to surgery, in inaccessible tumors, post surgery sterilization and palliation.

A major complication of RT is that adjacent normal tissues are variably affected.

For Oropharyngeal cancer, major and minor salivary glands are damaged by RT since they fall in the radiation pathway. Atrophy and acinar degeneration are features most commonly found histologically.

Xerostomia is defined as dry mouth resulting from reduced or absent saliva flow.

Xerostomia is not a disease, but may be a symptom of various medical conditions, a side effect of a wide variety of medications and a side effect of a radiation to the head and neck.The flow rate of normal unstimulated saliva is 0.3-0.5 ml/min. If it decreases to less than 0.1-0.2 ml/min, one would experience xerostomia.

According to researchers, the decrease in saliva and xerostomia that results from radiotherapy plays an important role in worsening Quality of Life(QoL) among patients who undergo radiotherapy for head and neck cancers.

Low level laser Therapy(LLLT) uses light energy in the form of photons to produce cellular responses in the cell. Light photons are absorbed by cytochromes and porphyrins in the mitochondria of the cell.

This study aims to prove that Low level laser therapy will improve salivary flow rate, pH and the quality of life in patients who have undergone Radiation therapy for oropharyngeal cancers.

详细描述

There are multiple treatment modalities the cancers of the head and neck. The main three major treatment options are surgery, radiation therapy and chemotherapy. Radiation therapy (RT) is used to control the growth of the tumor with limiting the damage to adjacent tissues. Surgery is the main treatment for oropharyngeal cancers, but if the cancer remains, radiation and chemotherapy is used in adjunct to surgery. Radiation therapy is a common treatment options for initial to mid stage malignancies.

A major complication of RT is that non neoplastic tissues of the head and neck are variably affected. The exact amount of damage to healthy tissues depends on factors such as fraction of radiation dose, the total amount of the radiation dose administered, volume of irradiated tissue, and how the dose is distributed in the tissue. The effect on the tissues may appear either during the treatment (acute) or once the treatment is complete (late).

For Oropharyngeal cancer, major and minor salivary glands are mostly affected by RT due to the fact that salivary glands fall in the radiation pathway. The mechanisms by which the tissues and cells are damaged due to radiation are still not very clear, but the features most commonly found histologically are atrophy of the tissues and degeneration of the acini. According to researchers, "the decrease in saliva and xerostomia that results from radiotherapy plays an important role in worsening Quality of Life (QoL) among patients who undergo radiotherapy for head and neck cancers". The normal flow rate of unstimulated saliva is 0.3-0.5 ml/min. If it decreases to less than 0.1-0.2 ml/min, it is then that one would experience xerostomia Xerostomia Inventory (XI) which was formulated by Thomson is a validated tool which will also be used to determine the amount of dryness based on the XI score. A higher score will be suggestive of worsening xerostomia.

The most commonly recommended treatment for xerostomia currently is intraoral topical agents. These include salivary stimulants, chewing gums, topical sprays containing malic acid. Also used for xerostomia are medicines such has pilocarpine and cevimeline but both medicines are parasympathomimetic and need to be administered with extreme caution. The effectiveness of there medicines is short lived and only provide symptomatic relief.

Generally, the mechanism by which Low level laser Therapy(LLLT) works is that photons are generated through the light energy and these photons produce cellular responses in the cell. The photons of light are readily absorbed by the cytochromes and the porphyrins present in the mitochondria of the cell.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with radiation induced persistent xerostomia which will be confirmed clinically and by taking salivary flow rate. Patients which will have salivary flow rate less than 0.1-0.2 ml/min shall be included.
  • Patients treated with therapeutic RT for oropharyngeal cancers 3 to 36 months ago
  • Patients whose age was equal to or more than 18 years irrespective of gender.

排除标准

  • Patients with other determined causes of xerostomia which have been confirmed. Systemic conditions (specially checking and excluding patients having dehydration,patients with known diseases of salivary glands, salivary glands removal surgery, smoking, diabetes, and autoimmune disorders among such as Sjögren's syndrome and drugs that cause xerostomia.

结局指标

主要结局

Increase in Quality of Life questionnaire Score

时间窗: 12 weeks

Increase in the quality of life in patients who have undergone Radiation therapy for oropharyngeal cancers. The questionnaire has 13 close ended questions. The total score of the questionnaire will be between 0-1300 A higher score will indicate improvement in the quality of life and will be compared with the score taken at baseline, before the start of the study.

Increase in Salivary flow rate

时间窗: 12 weeks

Increase in salivary flow rate in patients who have undergone Radiation therapy for oropharyngeal cancers.

Increase in pH

时间窗: 12 weeks

Increase in pH in patients who have undergone Radiation therapy for oropharyngeal cancers.

次要结局

未报告次要终点

研究者

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

Dr. Danial Arshad

Principal Investigator

Ziauddin University

研究点 (2)

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