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Acupuncture for Radiation-Induced Dry Mouth

Phase 3

Waitlist Available

Led By Lorenzo Cohen, PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will study if acupuncture can help prevent dry mouth and improve quality of life for patients who have received radiation to the head and neck.

Who is the study for?

This trial is for adults with head and neck cancer, primarily oropharyngeal, who are about to receive IMRT possibly with chemotherapy. Participants must have intact salivary glands and a performance status indicating they can carry out daily activities. Excluded are those with prior dry mouth issues, previous radiation treatment in the area, certain systemic illnesses like Sjögren's disease, bleeding disorders, deformities affecting acupuncture points, skin infections near acupuncture sites, CNS injuries or severe mental/emotional conditions.

What is being tested?

The study tests if acupuncture can prevent dry mouth caused by radiation therapy in head and neck cancer patients. It compares two different acupuncture techniques against standard care without acupuncture to see which is more effective at preventing xerostomia and improving quality of life.

What are the potential side effects?

Acupuncture may cause minor side effects such as slight pain where needles are inserted, bruising or bleeding at the sites, dizziness or fainting. Serious side effects are rare but could include infection or injury from needles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self-Reported Xerostomia Symptoms Using the Xerostomia Questionnaire (XQ)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Standard CareExperimental Treatment2 Interventions

Standard oral care recommendations. Participants in all groups will receive the same recommendations. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.

Group II: Acupuncture - Group 1Experimental Treatment3 Interventions

Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.

Group III: Acupuncture - Group 2Active Control3 Interventions

Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.

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