Acupuncture for Radiation-Induced Dry Mouth

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Warfarin, Heparin, Amifostine, others

Disqualifiers: Prior radiation, Sjögren's, Illicit drugs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

435 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that affect salivary function, such as amifostine, cholinergic agonists, certain beta blockers, anticholinergic agents, or any saliva substitutes.

What data supports the effectiveness of acupuncture as a treatment for radiation-induced dry mouth?

Research shows that acupuncture can increase salivary flow rates in patients with radiation-induced dry mouth, with improvements often persisting over time. In one study, 68% of patients receiving classical acupuncture experienced increased salivary flow, suggesting it might be a helpful treatment for this condition. ^{1 2 3 4 5}

Is acupuncture safe for treating radiation-induced dry mouth?

Acupuncture is generally considered to have rare side effects, making it a widely used treatment for dry mouth after radiotherapy. ^{1 2 6 7 8}

How does acupuncture treatment differ from other treatments for radiation-induced dry mouth?

Acupuncture is unique because it uses fine needles to stimulate specific points on the body, potentially increasing salivary flow and providing symptom relief for dry mouth caused by radiation, whereas other treatments often offer little benefit. Unlike standard treatments, acupuncture may provide sustained improvement in salivary flow rates, making it a promising alternative for managing this condition. ^{1 2 3 4 9}

What is the purpose of this trial?

The goal of this clinical research study is to learn if acupuncture can help to prevent xerostomia (dry mouth) and improve the quality of life in patients who receive radiation treatment to the head and neck. This study will determine if one acupuncture treatment approach is more effective than another. Dry mouth is a common problem among cancer patients who have received radiation treatment to the head and neck.

Research Team

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Diagnosed with head and neck cancer, which will be primarily oropharyngeal, and scheduled to undergo IMRT with or without concurrent chemotherapy at M. D. Anderson

Treatment plan that includes external beam radiation at a mean dose of at least 24 Gy or more to one of the parotid glands (the other gland can receive less than 24 Gy)

Your salivary glands (parotid and submandibular) are not damaged or removed.

Exclusion Criteria

Prior head and neck radiation treatment

Suspected or confirmed physical closure of salivary gland ducts on either side

You have a history of dry mouth before receiving radiation therapy for head and neck, or you have a condition like Sjögren's disease that causes dry mouth.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive radiation treatment to the head and neck. Group 1 and 2 receive acupuncture during this period.

7 weeks

Up to 21 visits for acupuncture (3 per week)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2-4, 5-9, and 10-15 months post-treatment.

10-15 months

3 follow-up visits

Post-Study Acupuncture Offer

Participants in Group 2 or 3 are offered 3 acupuncture treatments after study completion.

Treatment Details

Interventions

• Acupuncture

Trial Overview 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.

Participant Groups

Group I: Standard Care Experimental Treatment 2 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 1 Experimental Treatment 3 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 2 Active Control 3 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.

Acupuncture is already approved in United States, European Union, China for the following indications:

Approved in United States as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Approved in European Union as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression

Approved in China as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Sham-controlled, randomised, feasibility trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Acupuncture treatment of patients with radiation-induced xerostomia. [2019]

4. China pubmed.ncbi.nlm.nih.gov

The standardization of acupuncture treatment for radiation-induced xerostomia: A literature review. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Acupuncture treatment of xerostomia caused by irradiation of the head and neck region: case reports. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for the treatment of radiation-induced xerostomia among patients with cancer: A protocol for a systematic review and meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Acupuncture for patients with cancer-induced xerostomia: a systematic review protocol. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for Radiation-Induced Xerostomia in Cancer Patients: A Systematic Review and Meta-Analysis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A Phase I-II study in the use of acupuncture-like transcutaneous nerve stimulation in the treatment of radiation-induced xerostomia in head-and-neck cancer patients treated with radical radiotherapy. [2022]