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Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is \>500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a study diary to record symptoms of oral mucositis.

Control Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC \>500 after nadir or oral mucositis resolves (whichever occurs later)

Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:

* Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.

  o Participants may increase the use to 6 times per day if you have symptoms of mucositis.
* Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.

  * For younger patients (less than or equal to 6 years of age), volume may be reduced to two syringes containing 5-10 mL each.
  * For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Repeat using the second syringe.
* Patients are to avoid other oral medications, other mouth cares and food or drink for 15 minutes after using Caphosol.
* Patients may use Biotene (5-10 mL) to swish and spit after the 15 minutes has passed

Caphosol

• Use 5 to 10 mL of Biotene to swish and spit

o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab.

Biotene

Michael E Burke, MD

The purpose of this study is to determine if the administration of Caphosol rinse, at the start of chemotherapy, will prevent the development of mucositis (greater than or equal to grade 2 in children, adolescents and young adults. This is a randomized, controlled trial.

Oral mucositis, is a common and debilitating complication of cancer therapy. It is an inflammatory injury to the epithelial and sub-epithelial cells of the oral mucosa. The incidence and severity of oral mucositis depends on many factors including the age and diagnosis of the patient, the specific treatment regimen, underlying oral hygiene and genetic factors 2-4. This ranges from around 40% of patients getting chemotherapy for solid tumors to 70-90% of patients getting chemotherapy for before stem cell transplant.

Oral mucositis causes significant pain, interferes with eating, talking and swallowing, significantly diminishes enteral nutritional intake and has a substantial negative impact on quality of life. Patients may require hospitalization for management of the complications of mucositis, including poor nutrition, dehydration and pain. Injury to the oral mucosa also increases the risk of systemic infections. Finally, the development of oral mucositis may require delays or dose reductions in future chemotherapy courses, potentially jeopardizing disease cure rates.

Despite all that is known about the mechanism, course and complications of oral mucositis, there are no consensus guidelines on prevention or treatment of chemotherapy-induced oral mucositis and there is significant variation on approach to mucositis across treatment centers.

Caphosol (Jazz Pharmaceuticals, Inc. Palo Alto, CA) was designed in part to replace the normal ionic and pH balance of the oral cavity and been used to prevent and/or treat oral mucositis. Caphosol is hypothesized to diffuse into epithelial intracellular spaces and permeate mucosal lesions in oral mucositis.

This study is a randomized, controlled trial evaluating the use of topical Caphosol therapy to prevent oral mucositis (Grade ≥ 2) in children, adolescents and young adults undergoing chemotherapy. At the time of enrollment, patients will be randomized to either the control arm or the Caphosol arm. The treatment period will extend from the start of chemotherapy and continue for 7 days after completion of chemotherapy AND until the ANC is \> 500 after nadir (count recovery) or until the symptoms of oral mucositis resolve; whichever occurs last.

Study patients will be recruited from the MACC Fund Center and the oncology inpatient service. Study entry is open to patients regardless of gender or ethnic background. While there will be every effort to seek out and include females and minority patients, the patient population is expected to be no different than that of other oncology studies at the Medical College of Wisconsin.

Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy

Caphosol Study: A Randomized Controlled Open-Labeled Trial Investigating Topical Caphosol for Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy

Any adverse events attributable to caphosol therapy being given 4 times daily

The development of Mucositis Grade \>/= 2 in children receiving chemotherapy as evaluated using CTCAE 4.0

Medical College of Wisconsin

Associate Professor of Pediatrics

Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is \>500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a study diary to record symptoms of oral mucositis.

Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:

• Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.

o

• Patients may use Biotene (5-10 mL) to swish and spit after the 15 minutes has passed

Caphosol Arm

Control Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC \>500 after nadir or oral mucositis resolves (whichever occurs later)

Biotene: • Use 5 to 10 mL of Biotene to swish and spit

o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab.

Control Arm

Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is \>500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a diary to record symptoms of oral mucositis.

Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:

* Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.

  o Participants may increase the use to 6 times per day if you have symptoms of mucositis.
* Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.

  * For younger patients (less than or equal to 6 years of age), volume may be reduced to two syringes containing 5-10 mL each.
  * For patients unable to successfu

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

We had only 1 enrollment overall and that was to the Caphosol arm.

Michael J Burke, MD

Mucositis Grade >/= 2

Mucositis Grade </=2

Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is \>500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a study diary to record symptoms of oral mucositis.

Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:

* Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.
* Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.
* Patients may use Biotene (5-10 mL) to swish and spit after the 15 minutes has passed

We only had 1 patient enrolled on the Caphosol Arm and none on the Control Arm

Measure the Development of Oral Mucositis (Grade >/= 2) in Children, Adolescents and Young Adults.

1 patient enrolled on Caphosol and None on Control Arm

Tolerability of Four Times Daily Caphosol Therapy

Overall Study

Symptoms and General Pathology

Musculoskeletal Diseases

Eye Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Neoplasms

Rare Diseases

Syndrome

Sjogren's Syndrome

Head and Neck Neoplasms

Xerostomia

Arthritis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Salivary Gland Diseases

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Lacrimal Apparatus Diseases

Connective Tissue Diseases

Autoimmune Diseases

Oculocerebral Syndrome With Hypopigmentation

Single dose stick without any active substance

Multidose moisturizing oral spray without any active substance

14-day treatment with salivary equivalent sticks

Salivary equivalent

14-day treatment with Aequasyal oral spray

Aequasyal

Michel SALOM, Medical

The purpose of this study is to evaluate the clinical efficacy, safety and acceptability of our new oral salivary equivalent in the relief of signs and symptoms related to mouth dryness as compared to two distinct moisturizing currently marketed oral sprays (Aequasyal® \& Biotene®) in patients with xerostomia due to chronic hyposalivation.

National, multicentre, randomised, active controlled, crossover, open-label study using a 3-latin-square design.

200 evaluable patients have been recruited

A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study

Phase 4 Study Evaluating Efficacy, Safety and Acceptability of Treatment With a New Salivary Equivalent Compared to Two Moisturizing Mouth Sprays on the Improvement of Dry Mouth Symptoms and Oral Comfort in Patients With Xerostomia.

Patient evaluation through the completion of a self rated 100 mm long VAS score. Anchor points of the VAS score will be 0 representing the absence of any dry mouth symptoms and 100 representing the worst imaginable picture of dry mouth discomfort

Patient evaluation through the completion of a self rated 100 mm long VAS score.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy	NCT02539342	Oral Mucositis	Caphosol Biotene	- 25 Years	Medical College of Wisconsin
Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy	NCT02539342	Oral Mucositis	Caphosol Biotene	- 25 Years	Medical College of Wisconsin
A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study	NCT02049112	Xerostomia Hyposalivation Head and Neck C... Sjögren Syndrom...	Salivary equiva... Aequasyal Biotene	18 Years -	Unither Pharmaceuticals, France

Spots Global Cancer Trial Database for biotene

Every month we try and update this database with for biotene cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for biotene

Every month we try and update this database with for biotene cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for biotene cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.