Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis
Condition: Advanced Cancers
MeSH terms: Mucositis; Esophagitis
Intervention: Placebo; Glutamine; Questionnaires
Intervention description: mTOR Inhibitor Patient Group: Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.; mTOR Inhibitor Patient Group - Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.; Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No
Keywords: Advanced Cancers; Mucositis; Esophagitis; mTOR Inhibitor-based Regimen; Radiation to the Esophagus; Thoracic malignancies; Placebo; Glutamine; Enterex; Glutapak-10; NutreStore; Resource; GlutaSolve; Sympt-X G.I.; Sympt-X; Questionnaires; Surveys

Summary:

      The goal of this clinical research study is to learn if glutamine can help control and
      prevent sores, blisters, or inflammation in your mouth or esophagus due to your current
      treatment.

      In this study, glutamine will be compared to a placebo. A placebo is not a drug. It looks
      like the drug but is not designed to treat any disease or illness. It is designed to be
      compared with a study drug to learn if the study drug has any real effect.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who will be initiating therapy with any investigator-initiated mTOR inhibitor
             based therapy in the Department of Investigational Cancer Therapeutics (Phase I
             Program) or initiating radiation therapy to the esophagus.

          2. For the esophagitis arm, any patient with thoracic malignancies, which will receive
             radiation alone or concurrent chemo/radiation. Radiation dose must be >/= 45 Gy. For
             the esophagitis arm, induction chemotherapy is allowed.

          3. Ability to understand and the willingness to sign a written informed consent. A signed
             informed consent must be obtained prior to any study specific procedures.

          4. Patients must be >/= 17 years of age.

          5. Females of childbearing potential must have a negative pregnancy test. Sexually active
             patients must agree to use contraception prior to, during, and 30 days after last
             dose.

        Exclusion Criteria:

        1) Patients currently receiving therapy for mucositis.