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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Xerostomia Following Radiotherapy; Head and Neck Cancer

Treatments: Other: Medical treatment; Other: Pseudo-LASER acupoints therapy; Other: LASER acupoints therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07029854

P.T.REC/012/005539

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups, including a placebo group

LASER acupoints therapy + Medical treatment

Experimental group

Description:

This group will include twenty-seven patients suffering xerostomia (dryness of mouth), who will receive LASER acupoints therapy (3 times per week, for 4 weeks), plus medical treatment.

Treatment:

Other: LASER acupoints therapy

Other: Medical treatment

Pseudo-LASER acupoints therapy + Medical treatment

Placebo Comparator group

Description:

This group will include twenty-seven patients suffering xerostomia (dryness of mouth), who will receive pseudo-LASER acupoints therapy plus medical treatment (for 4 weeks).

Treatment:

Other: Pseudo-LASER acupoints therapy

Other: Medical treatment