Apply Acticoat absorbent onto the ulcer
Acticoat absorbent: Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval

Acticoat Absorbent

Apply Honey gel sheet onto the ulcer
Honey gel sheet: Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval

Honey Gel Sheet

Apply Jelonet onto the ulcer
Jelonet: Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval

Jelonet

Total

Sex: Female, Male

Race and Ethnicity Not Collected

The number of participants have absence of a visible wound achieved by complete epithelialization

Number of Participants With Complete Healing of Ulcer During the Observation Period

Change in Ulcer Size

the Change in Concentration of Matrix Metalloproteinases-9 (MMP-9) Level Inside Wound Fluid at Week 1 and Week 4

the Change in Concentration of Tumor Necrosis Factor Alpha (TNF-α) Level Inside Wound Fluid at Week 1 and Week 4

the Change in Concentration of Interleukin-1 Alpha (IL-1α) Level Inside Wound Fluid at Week 1 and Week 4

Overall Study

Dr. Tsang Ka-Kit

Diabetic Foot

Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval

Acticoat absorbent

Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval

Honey gel sheet

Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval

Diabetic Foot Ulcer Study on Topical Interventions

Randomized, Controlled Study of Nanocrystalline Silver, Manuka Honey and Conventional Dressing in Healing Diabetic Foot Ulcer

Tsang Ka Kit

Nurse consultant

Queen Elizabeth Hospital, Hong Kong

The Hong Kong Polytechnic University

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

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)

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

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

NRG Oncology

Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed

Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed

Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed
manuka honey: Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.

Honey

Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed
placebo gel: Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.

Placebo

Weight

Diabetic

Smoker

ECOG > 0

Chemotherapy

Gy = Gray; the international system unit of radiation dose

Radiation Therapy => 7,000 Gy

Worst Radiation Therapy Oncology Group (RTOG) score greater than or equal to Grade 3 mucositis The scale ranges from Grade 0 (No mucositis) to Grade 4 (Necrosis or deep ulceration ± bleeding) where Grade 0 is the best outcome and Grade 4 is the worst outcome.

Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment

Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had a Minimum of 2 Mucositis Assessments

Dr. Philippa Hawley

Radiotherapy Induced Mucositis

Head and Neck Cancer

Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.

manuka honey

Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.

placebo gel

BC Cancer Agency

A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer

British Columbia Cancer Agency

The study was blinded to all except necessary pharmacy staff until after the study was closed.