Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.

Supportive Care

Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.

Liquid Manuka Honey

Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.

Lozenge Manuka Honey

Total

Sex: Female, Male

Esophagitis-related pain was measured using patient-reported pain on swallowing as assessed by the Numerical Rating Pain Scale (NRPS), an 11-point scale (0-10) in which 0 indicates no pain and 10 indicates the worst pain imaginable. Generally, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Change was calculated by subtracting the baseline value from the 4-week value. The experimental arms (honey) were compared to the standard arm (supportive care).

Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS)

Esophagitis-related pain was measured using patient-reported pain on swallowing as assessed by the Numerical Rating Pain Scale (NRPS), an 11-point scale (0-10) in which 0 indicates no pain and 10 indicates the worst pain imaginable. Generally, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Change was calculated by subtracting the baseline value from values at the later time points. The experimental arms (honey) were compared to the standard arm (supportive care).

Radiation Esophagitis-related Pain During Treatment as Measured During Treatment and 12 Weeks by the Numerical Rating Pain Scale (NRPS)

Dysphagia, as reported by the patient, was measured by the patient swallowing diary. Swallowing score has increasing severity 1-5, where 1 = "none" and 5 = "cannot swallow liquids".

Dysphagia Via Daily Patient Log

The pain symptom subscale (2 items) evaluated pain and the global score (30 items) evaluated quality of life. Each ranges from 0-100 with lower scores indicating lesser burden and improved symptoms or quality of life.

Quality of Life and Pain, as Measured by the EORTC QLQ-30 Global QOL Score and Pain Symptom Subscale at 4 and 12 Weeks

Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For esophagitis specifically, Grade 3 criteria includes severely altered eating/swallowing, tube feeding, total parenteral nutrition (TPN) or hospitalization indicated. Grade 4 criteria include life-threatening consequences, urgent operative intervention indicated.

Percentage of Participants With Radiation Esophagitis Grade 3-4 (CTCAE v. 4)

Percent Change in Weight From Baseline to 4 Weeks

Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks)

The percentage of patients using opioid analgesics is reported. Use of opioid analgesics was assessed for a 24-hour period before completing the assessment. Patients with at least one reported administration of opioid analgesic were considered to have received opioid analgesics.

Percentage of Patients Using Opioids

Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Adverse Events Associated With Manuka Honey Using CTCAE v4.0

Change from baseline to four weeks in patient-reported difficulty in swallowing via the PRO-CTCAE. PRO-CTCAE is an item bank consisting of individual items to assess adverse symptom events from the patient perspective. There are 78 symptoms included in the survey but the primary item of interest assesses difficulty swallowing. For each AE in the PRO-CTCAE, between 1 and 3 items are included to assess the frequency, severity, and/or interference with activities related to that AE. Frequency questions have responses ranging from never, which is scored as a 0, to almost constantly, which is scored as a 4. Severity questions have responses ranging from none, which is scored as a 0, to very severe, which is scored as a 4. Interference questions have responses ranging from not at all, which is scored as a 0, to very much, which is scored as a 4. Difficulty in swallowing only has a severity question.

Patient Reported Difficulty in Swallowing Associated With Manuka Honey Using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Overall Study

Wendy Seiferheld, M.S.

Dysphagia

Lung Cancer

Pain

Esophagitis

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.

Manuka honey in liquid form

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.

Manuka honey in lozenge form

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.

Standard supportive care

Providence Cancer Center at Providence Hospital

UCSF Helen Diller Family Comprehensive Cancer Center

Stanford Cancer Center

CCOP - Christiana Care Health Services

Baptist Cancer Institute - Jacksonville

CCOP - Mount Sinai Medical Center

Florida Cancer Center - Palatka

Piedmont Fayette Hospital

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Queen's Cancer Institute at Queen's Medical Center

Hawaii Medical Center - East

OSF St. Francis Medical Center

CCOP - Carle Cancer Center

Parkview Regional Cancer Center at Parkview Health

Cancer Center at Ball Memorial Hospital

Lucille P. Markey Cancer Center at University of Kentucky

Cape Cod Hospital

CentraCare Clinic - River Campus

Regional Cancer Center at Singing River Hospital

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

David C. Pratt Cancer Center at St. John's Mercy

Payson Center for Cancer Care at Concord Hospital

Seacoast Cancer Center at Wentworth - Douglass Hospital

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Elliot Regional Cancer Center at Elliot Hospital

Monmouth Medical Center

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

CCOP - Hematology-Oncology Associates of Central New York

Highland Hospital of Rochester

James P. Wilmot Cancer Center at University of Rochester Medical Center

Presbyterian Cancer Center at Presbyterian Hospital

Duke Cancer Institute

Pardee Memorial Hospital

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

Rex Cancer Center at Rex Hospital

Wake Forest University Comprehensive Cancer Center

Trinity CancerCare Center

Mercy Cancer Center at Mercy Medical Center

Case Comprehensive Cancer Center

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland Clinic Taussig Cancer Center

Cleveland Clinic Cancer Center

Hillcrest Cancer Center at Hillcrest Hospital

Parma Community General Hospital

Rosenfeld Cancer Center at Abington Memorial Hospital

Bryn Mawr Hospital

Geisinger Cancer Institute at Geisinger Health

Northeast Radiation Oncology Center

Adams Cancer Center

Cherry Tree Cancer Center

Cancer Center of Paoli Memorial Hospital

Lankenau Cancer Center at Lankenau Hospital

York Cancer Center at Apple Hill Medical Center

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

University of Texas Medical Branch

University of Texas Health Science Center at San Antonio

St. Joseph Cancer Center

St. Mary's Hospital Medical Center - Green Bay

St. Vincent Hospital Regional Cancer Center

Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer

Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer

leptospermum myrsinoides/減肥

Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer

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