View clinical trials related to Mucositis.
Filter by:The treatment of cancer in children may result in an extremely painful condition called oral mucositis when the cells lining the mouth are injured due to the cancer medication. Patients with this condition are often unable to take anything by mouth or to swallow their own saliva. This severe pain may last for as long as 2 weeks. A survey of our previous 22 patients showed high daily pain scores despite the use of intravenous (given through a small tube in a vein) opioid medications (family of pain relieving drugs, e.g. morphine and hydromorphone). The purpose of this pilot study is to determine which of 3 concentrations of ketamine to combine with hydromorphone to provide the best pain relief with minimum side effects. The results from this study will allow us to do a larger study to compare the best concentration found from this study to standard treatment. If successful, this combination of ketamine and hydromorphone will also be used to treat other pain problems in children.
Zinc is an intracellular mineral with important enzymatic cofactor activities for cell membrane stability, DNA and RNA structure. Zinc deficiency is associated with delayed wound healing and immune dysfunction. In patietns with hematological malignancies an inverse correlation was found between disease stage and zinc level. Patients undergoing high dose chemotherapy for hematologic malignancies are predisposed to develop oral and gastrointestinal complications, in particular oral mucositis. These patients may have relative zinc deficiency, therefore oral zinc therapy may be benefical in the prevention of these complications.
The purpose of this study was to evaluate the efficacy and effect of palifermin on the incidence of oral mucositis in subjects with multiple myeloma receiving Melphalan followed by autologous peripheral blood stem cell transplantation. Amendment 01 (April 07) introduced three cataract assessments to be carried out at Screening, Month 6 and Month 12 in response to FDA and EMEA follow up measures.
Mucositis and xerostomia are the most common complications of head and neck (H&N) irradiation, and the combination of chemotherapy and radiation therapy is associated with a significantly higher rate of complications. Mucositis usually develops during the second or third week of a course of standard radiotherapy, and the pain it causes peaks between the third and last week of treatment. The pain then persists for at least one month following the completion of therapy, and may be so overwhelming that it prevents patients from swallowing food and fluids. The patient is therefore at a risk to develop malnutrition, and must be treated vigorously. In this respect, the use of gastrostomy tubes (PEG) has been shown to be beneficial. Completion of the full course of irradiation, without interruption, is important for achieving best possible results in cancer of the H&N. It is therefore essential to identify and refer patients at risk to receive effective and timely nutritional intervention. Since mucositis represents a clinical continuum which differs between patients, it is difficult to assess before-hand which patients will be at risk. There is no simple laboratory tool available, which could predict which patients are susceptible to develop severe mucositis and dysphagia, and eventually will require a feeding gastrostomy. The first phase of mucositis, inflammation, results in the production of pro-inflammatory cytokines such as interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-α). In general, the inflammatory cytokines IL-1, interleukin-6 (IL-6) and TNF-α are elevated in inflammatory conditions and are found in increased levels in blood and tissue fluid during inflammation, while anti-inflammatory cytokines are produced in a decreased manner. The main purpose of this study is to find the best indicators and prognosticators of mucositis occurring in the healthy oral tissues of H&N cancer patients receiving treatment, and to understand the cytokines balance mechanism of action. Assuming there is a correlation between high cytokines levels during inflammation and the severity of radiation induced mucositis, finding these prognostic factors may help us predict during the first part of the treatment the need for PEG, placing it prior to the complications associated with severe mucositis on one hand, and avoiding unnecessary procedures on the other hand.
Rationale for Study Oral mucositis is a major complication arising from contemporary chemoradiation treatment of patients with head and neck cancer. No effective therapy exists to prevent this complication in this population. MRX-1024 is an investigational agent that has demonstrated in in vitro and in vivo experiments to have the potential to exert a protective effect in normal mucosa cells, without interfering with the intended antitumor effect of radiation. A pilot Phase 1 study of MRX-1024 was conducted in India in patients with head and neck cancer receiving radiation alone or radiation in combination with cisplatin or carboplatin. MRX 1024 doses of 100 mgkg given orally twice a day, five days a week during radiation treatment cycles, were well tolerated and appeared to exert a protective effect against the development of severe mucositis. Twice daily doses of MRX 1024 impose a certain level of inconvenience to the patient, to their clinic companion, and to the general work flow within radiation oncology clinics. This study is designed to study the safety and pharmacokinetics of both single daily dose and twice daily dose regimens of oral MRX 1024 given in conjunction with daily radiation fractions and intermittent high-dose cisplatin to patients with high-risk for recurrence head and neck cancer following surgical resection. The study will also document the incidence and severity of oral mucositis that occurs following such therapy. The results will be instrumental in determining the regimen of MRX 1024 to use in subsequent definitive clinical trials.
The purpose of this study is to evaluate the efficacy, safety, and tolerability of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of oral mucositis in subjects with stage 2B and 3 locally advanced, colon cancer receiving chemotherapy as an adjuvant treatment for their disease.
Oral mucositis (OM) is a common and debilitating toxicity induced by many chemotherapy (CT) regimens and by radiation to the head and neck. The purpose of this study is to determine the effectiveness of SNX-1012 in decreasing the duration of Grade 2, 3, or 4 oral mucositis (OM) according to World Health Organization (WHO) criteria.
RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving radiation therapy and chemotherapy for head and neck cancer. PURPOSE: This randomized phase III trial is studying palifermin to see how well it works compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy and chemotherapy for locally advanced head and neck cancer.
A comparative trial where all patients will receive daily doses of tacrolimus (TAC) until day +60 when tapering will begin, in the absence of graft-versus-host disease (GVHD), and discontinued by day +180. In addition patients will be randomized to methotrexate (MTX) or mycophenolate mofetil (MMF) and again, in the absence of GVHD, a tapering schedule will begin on day +240 and be completed on day +360. Doses will be adjusted to maintain blood levels.
Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often associated with painful ulcers in the mouth. The study hypothesis is that morphine administrated as a mouthwash can relieve stomatitis-related pain by a local analgesic effect. The purpose of this study is to test the analgesic effect of a morphine mouthwash versus morphine injections or placebo (no active drug) in children/adolescents with stomatitis related to chemotherapy. Besides the investigational drugs (morphine mouthwash and morphine injections) the children/adolescents receive a standardized analgesic treatment for stomatitis-related pain.