CLINICAL TRIAL

intra-parotid administration of AAV2hAQP1 for Xerostomia

Waitlist Available · 18+ · All Sexes · Charlotte, NC

A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia

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About the trial for Xerostomia

Eligible Conditions
Xerostomia Due to Radiotherapy · Xerostomia · Head and Neck Cancer · Radiation-Induced Parotid Gland Hypofunction

Treatment Groups

This trial involves 12 different treatments. Intra-parotid Administration Of AAV2hAQP1 is the primary treatment being studied. Participants will be divided into 12 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
intra-parotid administration of AAV2hAQP1
DRUG
Experimental Group 2
AAV2hAQP1: 1 x 10^11 vg/gland (both glands)
DRUG
Experimental Group 3
AAV2hAQP1: 3 x 10^10 vg/gland (both glands)
DRUG
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Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
History of radiation therapy for head and neck cancer.
You have normal parotid gland function as judged by both absence of unstimulated parotid salivary flow and a stimulated parotid salivary flow in the targeted parotid gland >0 and <0. show original
No evidence of recurrence of the primary malignancy by an otolaryngology (ears, nose, and throat [ENT]) assessment. Additionally, all subjects must be disease-free of head and neck cancer for at least 5 years following the end of treatment at screening, with the exception of subjects with a history of HPV+ OPC (base of tongue, oropharynx, pharynx, soft palate, tonsil) who must be disease free for at least 2 years following the end of treatment. Disease status will be determined by negative clinical examinations and computed tomography (CT) scans of the neck and chest. If subjects have had a magnetic resonance imaging (MRI) of the neck or a positron emission tomography (PET) scan within 6 months of screening, then a CT scan is not required, except for HPV+ OPC subjects who must have scans at 2 years post treatment.
Intrauterine device for at least 12 weeks prior to Screening.
Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks prior to Screening.
Diaphragm used in combination with spermicide.
You are male or female, aged 18 years or older. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: one day to one year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: one day to one year.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether intra-parotid administration of AAV2hAQP1 will improve 1 primary outcome in patients with Xerostomia. Measurement will happen over the course of one day to one year.

The is safety of AAV2hAQP1 administered to the parotid gland of adult subjects with radiation-induced xerostomia
ONE DAY TO ONE YEAR
Safety will be assessed by number of adverse events occurring with treatment

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is xerostomia?

Xerostomia is the condition of having dry mouth, usually due to some problem with salivary gland function. Diagnosing xerostomia is difficult because signs and symptoms are often poorly described and patients tend to be worried about losing their ability to chew or speak.\n

Anonymous Patient Answer

What causes xerostomia?

The most common causes were radiation therapy and head and neck surgery; otherwise XO is a rare condition. There may be a role for drugs; however, only small-level evidence is currently available.

Anonymous Patient Answer

How many people get xerostomia a year in the United States?

About 1.7 million people in the United States have xerostomia, or dry mouth. The condition and its potential management are not commonly discussed by physicians (e.g., the American Society of Health-System Pharmacists).

Anonymous Patient Answer

Can xerostomia be cured?

Patients with salivary gland dysfunction due to xerostomia can achieve complete denture base coverage with excellent oral hygiene and careful clinical monitoring. This condition cannot be cured.

Anonymous Patient Answer

What are the signs of xerostomia?

Most patients will present with dry mucosa, particularly in the front of the mouth and inside the cheeks. These can develop to become more obvious and severe as the disease progresses. In a minority of patients, the disorder presents with symptoms such as headache; a sore throat; a sensation of tightness in the lips; and parotitis. Patients should be reassured that these symptoms are common, and should be given a sample of xerostomal fluids to take home. It may be helpful to ask friends or family members to give a sample where they can send any fluid and a self-reported diary for use whenever required.

Anonymous Patient Answer

What are common treatments for xerostomia?

Xerostomias are common in elderly people. Some methods of management include the placement of a soft palate appliance with a submucosal implant, autologous fat, or an autologous tissue transplant. There is some controversy about the use of saliva-producing transplants in conjunction with a palatal prosthesis. There is also little evidence regarding the use of botulinum toxin for the alleviation of xerostomia.

Anonymous Patient Answer

How serious can xerostomia be?

Xerostomia is a very common symptom of primary neurological disease. It is important to treat with utmost attention and consideration. In some cases, xerostomia may represent the earliest sign of progressive neurological disease. It is important to recognize this possibility and to consider treating xerostomia as early as possible. There are two options for treating xerostomia: a topical fluoride application and a topical application of artificial saliva. For the second option, topical fusicoccin gel is generally effective. For the fluoridation, one application is usually enough. There is a recent Cochrane Review of Follicular Dermoplegia which indicates application of topical chlorhexidine gel 3 or 4 times a day.

Anonymous Patient Answer

Is intra-parotid administration of aav2haqp1 typically used in combination with any other treatments?

Aav2haqp1 has been reported to reduce facial pain, but is used at doses that often lead to severe side effects. Considering the limited benefit and severe side effects, the use of the toxin in combination with other treatment may be sub-optimal. Results from a recent paper suggest that the benefit of aav2haqp1 on the pain phenotype may be augmented by the use of oral analgesics. However, further research on the pharmacokinetics of oral analgesics is needed to determine whether the reduction in the dosage of Aav2haqp1 can improve its effectiveness.

Anonymous Patient Answer

Have there been other clinical trials involving intra-parotid administration of aav2haqp1?

The current study found a significant improvement in both salivary and mouthwash components compared to controls; however, a single-center study and more subjects in a randomized control study would more definitively elucidate the benefits associated with the treatment. Further studies are warranted.

Anonymous Patient Answer

What is the average age someone gets xerostomia?

Sjogren's Syndrome has a prevalence of 3 times lower than expected, and is less common than other connective tissue disorders, with the most common age at diagnosis occurring between 40 and 50. Although xerostomia is a common symptom of Sjogren's Syndrome, in individuals with other connective tissue disorders, xerostomia occurs at a rate of less than 5%.

Anonymous Patient Answer

What is the primary cause of xerostomia?

The causes of xerostomia are the most varied because of many contributing factors. Xerostomia occurs secondary to a wide variety of causes. The most common cause of xerostomia is dry mouth secondary to conditions such as diabetes, Sjögren syndrome, or head and neck irradiation. However, in 30% of cases no direct cause can be documented. Xerostomia is the most common oral dryness syndrome and may lead to social dysfunction. Xerostomia is strongly linked to poor quality of life and is under-recognised which might lead to poor patient compliance.

Anonymous Patient Answer

Does xerostomia run in families?

The prevalence of xerostomia is estimated to be 2.7 to 4.7% among Taiwanese and 4.4 to 7.3% among northern Chinese with a male preponderance. No cases of familial xerostomia were observed in this study.

Anonymous Patient Answer
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