A Phase II Study Evaluating Manuka Honey to Reduce Chemoradiation-Associated Esophagitis Pain during Lung Cancer Treatment

Protocol
12-111
Full Title
Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer (RTOG 1012)
Purpose

Chemotherapy and radiation therapy for lung cancer may cause painful inflammation of the esophagus (esophagitis). This pain can make it uncomfortable for patients to swallow and make eating difficult.

In clinical studies, honey has been shown to be an effective wound dressing and to prevent blistering of the mouth that can occur during radiation treatment. In this Radiation Therapy Oncology Group study, researchers want to see if a medicinal honey, called Manuka honey, can prevent or delay the onset of esophagitis in patients receiving chemotherapy and radiation therapy for lung cancer.

Patients in this study will be randomly assigned to one of three groups: standard supportive care (pain-relieving medication), the honey in liquid form, or the honey in lozenge form.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be receiving chemotherapy and daily radiation therapy for non-metastatic lung cancer.
  • Patients may not have had severe swallowing problems before the start of radiation therapy.
  • Patients must be at risk of esophagitis (as determined by the radiation therapy field).
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Andreas Rimner at 212-639-6025.

Disease(s)
Lung Cancer
Lung Cancer, Non-Small Cell
Lung Cancer, Non-Small Cell: Lung Adenocarcinoma
Lung Cancer, Small Cell
Lung Cancer, Small Cell: Other