Acupuncture for Radiation-Induced Dry Mouth

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether acupuncture, a traditional Chinese medicine technique using needles, can prevent dry mouth and improve quality of life in people undergoing radiation treatment for head and neck cancer. Participants will either receive acupuncture with needles placed at various points to determine the most effective method or follow standard oral care recommendations. The trial seeks individuals with head and neck cancer who have not yet started radiation and have no prior history of dry mouth or related disorders. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that acupuncture is generally safe for people. Studies indicate that patients usually handle it well with few side effects. Acupuncture involves inserting thin needles into the skin at specific points, typically causing little to no pain.

Research has found that acupuncture can help manage dry mouth symptoms from radiation treatment in cancer patients. While it might not work for everyone, many patients report feeling better after treatment.

In summary, acupuncture is a low-risk option that has helped some patients with radiation-induced dry mouth feel more comfortable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about acupuncture for treating radiation-induced dry mouth because it offers a non-pharmacological approach that potentially enhances patient comfort without the side effects associated with traditional medications. Unlike standard treatments such as saliva substitutes or prescription medications like pilocarpine, acupuncture targets specific points on the body to stimulate saliva production naturally. This approach may not only improve saliva flow but also enhance overall well-being, making it a promising complementary option for patients undergoing radiotherapy. Additionally, acupuncture involves no chemical intake, which could make it a safer alternative for those who cannot tolerate medications.

What evidence suggests that this trial's acupuncture treatments could be effective for radiation-induced dry mouth?

Research has shown that acupuncture can help with dry mouth caused by radiation. Several studies indicate that acupuncture may increase saliva flow and relieve dry mouth symptoms after radiation treatment. In this trial, participants will be divided into groups to receive acupuncture at different points. True acupuncture has proven more effective than merely following oral hygiene advice for improving symptoms and quality of life. However, some reviews mention that while people report feeling better, clear proof of its effectiveness remains limited and requires further research. One study found that acupuncture significantly reduced the severity of dry mouth and related pain, with effects lasting up to six months. ^{1 3 6 7 8}

Who Is on the Research Team?

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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.

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.26550

Randomized controlled trial of acupuncture for prevention of ... The authors conducted a randomized, clinical trial of acupuncture to decrease the development of xerostomia in patients undergoing radiation ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S221176601400005X

Improvement of radiation-induced xerostomia with ... Conclusions. Combination acupuncture significantly decreases the severity of dry mouth and pain with long lasting effects, up to six months (at the end of data ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12163620/

Efficacy of Acupuncture in Managing Radiation-Induced ... Several studies and preliminary reviews suggest that acupuncture may improve salivary flow and reduce xerostomia severity in patients' post-radiotherapy,.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11091764/

Acupuncture for Chronic Radiation-Induced Xerostomia in ... True acupuncture was effective at improving symptoms of radiation-induced xerostomia and overall quality of life (QOL) compared with standard oral hygiene.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/hed.27297

Umbrella review: Summary of findings for acupuncture as ... No clinical meaningful effectiveness of acupuncture on xerostomia has been proven so far, but positive subjective findings need to be explored more.

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818644

Acupuncture for Chronic Radiation-Induced Xerostomia in ... True acupuncture was effective at improving symptoms of radiation-induced xerostomia and overall quality of life (QOL) compared with standard oral hygiene.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2757250

Effect of True and Sham Acupuncture on Radiation ... These findings suggest that acupuncture should be considered for the prevention of radiation-induced xerostomia, but further studies are needed.

8. mdanderson.org mdanderson.org/newsroom/acupuncture-reduces-radiation-induced-dry-mouth-for-cancer-patients.h00-159308568.html

Acupuncture reduces radiation-induced dry mouth for ... After receiving acupuncture treatment three days a week during the course of radiation treatment, head and neck cancer patients experienced less dry mouth.