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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 Caphos
Sponsor: Medical College of Wisconsin

Current Primary Outcome:

  • Occurrence and severity of oral mucositis based on subject reporting using a pain scale [ Time Frame: 24 months ]

    Change in baseline using age appropriate pain scales

    1. Likert Pain Rating Scale with scores ranging from 0 (no pain) to 10 (worst possible pain) - older children

    2. Wong-Baker FACES Pain Rating Scale - illustrations of faces with expressions corresponding to the following scores: (younger children will select the face that best describes how they are feeling)

      0 = Very Happy, No Hurt

      1. = Hurts Just a Little Bit
      2. = Hurts a Little More
      3. = Hurts Even More
      4. = Hurts a Whole Lot
      5. = Hurts as Much as You Can Imagine (Don't have to be crying to feel this much pain)
  • Occurrence and severity of oral mucositis based on treatment related adverse event grading scale [ Time Frame: 24 months ]
    Number of participants with treatment-related oral mucositis as assessed by the CTCAE v4.0 on a scale ranging from grade 1 (asymptomatic or mild symptoms) through progressively more severe symptoms up to grade 5 (Death).
  • Occurrence and severity of oral mucositis based on narcotic use [ Time Frame: 24 months ]
    Each subjects total narcotic usage to address

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Medical College of Wisconsin

    Dates:
    Date Received: August 20, 2015
    Date Started: October 2016
    Date Completion:
    Last Updated: May 5, 2017
    Last Verified: May 2017