Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer
Condition: Dysphagia; Lung Cancer; Pain; Esophagitis
MeSH terms: Lung Neoplasms; Deglutition Disorders; Esophagitis
Intervention: Manuka honey in liquid form; Manuka honey in lozenge form; Standard supportive care
Intervention description: Patients swallow 10 cc (approximately 2 level teaspoons) of liquid Manuka honey 4 times per day while awake over an approximately 12 hour period (e.g. 8 a.m., Noon, 4 p.m., and 8 p.m.) 7 days/week during concurrent chemotherapy and radiation treatment.; Patients place 2 lozenges (the equivalent of 10 cc of liquid Manuka honey), one at a time, in the mouth, allowing each lozenge to dissolve on the tongue/in the mouth, swallowing the honey as it dissolves. Patients do this 4 times per day while awake over an approximately 12 hour period (e.g. 8 a.m., Noon, 4 p.m., and 8 p.m.) 7 days/week during concurrent chemotherapy and radiation treatment.; Patients receive standard supporting care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment. The following regimen is recommended, but the local standard of care is permitted.
A compound containing viscous lidocaine and magnesium aluminum oxide (Maalox®);
Liquid or solid oxycodone, 5-10 mg, every 3 hours as needed.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pain; dysphagia; recurrent non-small cell lung cancer; stage IA non-small cell lung cancer; stage IB non-small cell lung cancer; stage IIA non-small cell lung cancer; stage IIB non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; extensive stage small cell lung cancer; limited stage small cell lung cancer; recurrent small cell lung cancer; esophagitis

Summary:

      RATIONALE: Manuka honey may prevent or reduce esophagitis-related pain caused by chemotherapy
      and radiation therapy. It is not yet known whether Manuka honey is more effective than
      standard care in preventing pain.

      PURPOSE: This randomized phase II clinical trial is studying Manuka honey to see how well it
      works in preventing esophagitis-related pain in patients receiving chemotherapy and radiation
      therapy for lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Patients being treated with combination chemotherapy (definitive or adjuvant) and
             radiation therapy once daily for small cell or non-small cell lung cancer (primary
             population for the trial)

               -  Patients can receive chemoradiotherapy while on a Radiation Therapy Oncology
                  Group (RTOG) lung trial or while not being on a clinical trial

               -  No patients receiving chemoradiotherapy while enrolled on a single institution
                  trial or trials coordinated by other cooperative groups

          -  No patients with metastatic disease

          -  At least 5 cm of the esophagus must be in the 60 Gy isodose volume in 1.6 to 2.0 Gy
             fractions

        PATIENT CHARACTERISTICS:

          -  Age 18 and up

          -  Able to swallow thick liquids prior to treatment

          -  Able to speak English or Spanish in order to complete required forms (verbal
             completion is adequate)

          -  No patients with poorly controlled diabetes

          -  No known hypersensitivity to honey

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No patients who have received prior chemotherapy or radiation therapy

          -  No patients receiving more than once daily treatments

          -  Therapeutic use of honey other than the Manuka honey provided for this trial is not
             allowed while patients are on study

          -  Patients must also avoid honey-flavored medical products and/or sugary, viscous
             substances

          -  Amifostine is not permitted