Laser Acupoints Stimulation on Xerostomia Related Chemoradiotherapy for Head and Neck Cancer Patients

Обзор

The purpose of the study is to evaluate to effect of LASER acupoints stimulations on xerostomia patients during chemoradiation therapy after head and neck cancer.

Подробное описание

The current diagnosis is based on the primary complaint reported by the patient. A previous study found that patients with cancer reported different degrees of dry mouth, reduced drinking and eating and waking up at night due to dry mouth and that the risk of progression to oral ulcers was higher among this patient population and could significantly affect the quality of life.

Acupuncture may be effective in treating xerostomia and also, acupuncture has been shown to increase salivary flow in healthy volunteers.

As xerostomia gradually comes to the attention of the wider medical community, clinical evidence is slowly starting to amass to help assess which treatments are most effective, but more research is needed. Furthermore, there is a lack in the quantitative knowledge and information in the published studies about benefits of acupuncture on xerostomia during chemo radiation therapy. So, this study is designed to outline the therapeutic efficacy of acupuncture on xerostomia during chemo radiation therapy.

Вмешательства

• Другое Medical treatment
  They will receive oral chemotherapy, based on the cancer stage, and will also undergo radiotherapy.
• Другое LASER acupoints therapy
  LASER acupoints therapy will use the Pointer Pulse device (GMT2000 s.r.l., Italy), emitting 650 nm red light with an audio trimmer for acupoint detection. Treatment parameters include 5 mW power, 120 s irradiation per point over a 3.14 mm² area (fluence: 19.2 J/cm², power density: 0.16 W/cm², total dose: 0.6 J). Continuous red laser will be applied for effective stimulation. Sessions will occur once weekly for five weeks. Bilateral stimulation will follow this order: left hand, left face, trunk,
• Другое Pseudo-LASER acupoints therapy
  For the pseudo-LASER acupoints therapy, the same procedures and sequence of acupoint application will be followed as in the active treatment. However, the Pointer Pulse device (GMT2000 s.r.l., Italy) will be deactivated to emit no therapeutic laser light while maintaining visual and audio cues to mimic real stimulation. The device will appear active to ensure blinding. Sessions will be conducted once weekly for five weeks, applying the probe to the same bilateral acupoints in the following order

Первичные конечные точки

• Xerostomia Inventory score [Срок оценки: 4 weeks]

Вторичные конечные точки (1)

• Stimulated salivary flow rate (SSFR) by Sialometry [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• Chemoradiation therapy
• Carcinoma in the head and neck area (NPC)
• Anatomically intact parotid and submandibular glands.
• All patients will be clinically and medically stable when attending the study.

Критерии исключения

• They had a history of xerostomia;
• They had suspected or confirmed physical closure of salivary gland.
• ducts on either side.
• They had known bleeding disorders.
• They Were taking heparin or warfarin.
• They had contraindications for the use of acupuncture at any acupoints.
• They had history of cerebrovascular accident or spinal cord injury.
• They had taken any drug or herbal medicine in the past 30 days that could affect salivary function.
• They were planning to, or ended up taking such a substance during the study.
• Any therapy that may affect treatment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• El Hussein university Hospital — Cairo

Идентификаторы

NCT: NCT07029854 · P.T.REC/012/005539

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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