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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01262560
Other study ID # RTOG 1012
Secondary ID RTOG-1012CDR0000
Status Completed
Phase Phase 2
First received December 16, 2010
Last updated August 29, 2017
Start date February 2012
Est. completion date November 2014

Study information

Verified date August 2017
Source Radiation Therapy Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

OBJECTIVES:

Primary

- Evaluate the relative efficacy of 4 times a day consumption of liquid or lozenge Manuka honey to delay or prevent radiation esophagitis-related pain (during combined chemotherapy and radiation therapy for lung cancer) as compared to standard supportive treatment, as measured at week 4 by Numerical Rating Pain Scale (NRPS) for pain upon swallowing.

Secondary

- Evaluate the trend of severity of radiation esophagitis-related pain during combined chemotherapy and radiation therapy for lung cancer using weekly measurements of the NRPS.

- Evaluate the adverse events associated with Manuka honey, as measured by CTCAE, v. 4.

- Evaluate the severity of radiation esophagitis (grade 3-4, CTCAE, v. 4).

- Assess weight loss (percent weight change from baseline to 4 weeks).

- Assess quality of life (QOL) and pain, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-30) global QOL score and pain symptom subscale.

- Assess patient-reported dysphagia via a daily patient log.

- Assess nutritional status, as measured by the mean change in serum prealbumin levels from baseline to 4 weeks.

- Assess opioid use by collecting the patient's narcotic use in the previous 24-hour period at each weekly evaluation.

- Evaluate patient-reported adverse events associated with Manuka honey using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

OUTLINE: This is a multicenter study. Patients are stratified according to the percentage of esophagus in the radiation field (V60 < 30% vs V60 ≥ 30%). Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients receive standard supportive care for esophagitis-related pain as needed during chemoradiotherapy.

- Arm II: Patients swallow liquid Manuka honey slowly over 3-5 minutes. Patients must refrain from eating and drinking for 1 hour after administration. Treatment continues 4 times per day during chemoradiotherapy.

- Arm III: Patients place Manuka honey lozenges in their mouth one at a time and swallow the honey as it dissolves (no chewing or swallowing it whole). Patients must refrain from eating and drinking for 1 hour after administration. Treatment continues 4 times per day during chemoradiotherapy.

Patients complete quality of life, pain swallowing diary, and pain assessments (Numerical Rating Pain Scale, EORTC QLQ-30 and Pain Subscale, and PRO-CTCAE) periodically during study treatment.

Patients are followed up at 12 weeks from the start of study treatment.


Recruitment information / eligibility

Status Completed
Enrollment 163
Est. completion date November 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Manuka honey in liquid form
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 lozenge 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.
Standard supportive care
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.

Locations

Country Name City State
United States Rosenfeld Cancer Center at Abington Memorial Hospital Abington Pennsylvania
United States St. Joseph Cancer Center Bellingham Washington
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Mercy Cancer Center at Mercy Medical Center Canton Ohio
United States Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina
United States Case Comprehensive Cancer Center Cleveland Ohio
United States Cleveland Clinic Cancer Center at Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Payson Center for Cancer Care at Concord Hospital Concord New Hampshire
United States Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania
United States Seacoast Cancer Center at Wentworth - Douglass Hospital Dover New Hampshire
United States Northeast Radiation Oncology Center Dunmore Pennsylvania
United States Duke Cancer Institute Durham North Carolina
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Piedmont Fayette Hospital Fayetteville Georgia
United States Parkview Regional Cancer Center at Parkview Health Fort Wayne Indiana
United States University of Texas Medical Branch Galveston Texas
United States Adams Cancer Center Gettysburg Pennsylvania
United States St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin
United States St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States Cherry Tree Cancer Center Hanover Pennsylvania
United States Pardee Memorial Hospital Hendersonville North Carolina
United States Hawaii Medical Center - East Honolulu Hawaii
United States Queen's Cancer Institute at Queen's Medical Center Honolulu Hawaii
United States Cape Cod Hospital Hyannis Massachusetts
United States Cleveland Clinic Cancer Center Independence Ohio
United States Baptist Cancer Institute - Jacksonville Jacksonville Florida
United States Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Lucille P. Markey Cancer Center at University of Kentucky Lexington Kentucky
United States Monmouth Medical Center Long Branch New Jersey
United States Elliot Regional Cancer Center at Elliot Hospital Manchester New Hampshire
United States Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton New Jersey
United States Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights Ohio
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States Trinity CancerCare Center Minot North Dakota
United States Providence Cancer Center at Providence Hospital Mobile Alabama
United States Cancer Center at Ball Memorial Hospital Muncie Indiana
United States CCOP - Christiana Care Health Services Newark Delaware
United States Florida Cancer Center - Palatka Palatka Florida
United States Cancer Center of Paoli Memorial Hospital Paoli Pennsylvania
United States Parma Community General Hospital Parma Ohio
United States Regional Cancer Center at Singing River Hospital Pascagoula Mississippi
United States OSF St. Francis Medical Center Peoria Illinois
United States FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Pinehurst North Carolina
United States Rex Cancer Center at Rex Hospital Raleigh North Carolina
United States Highland Hospital of Rochester Rochester New York
United States James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York
United States CentraCare Clinic - River Campus Saint Cloud Minnesota
United States David C. Pratt Cancer Center at St. John's Mercy Saint Louis Missouri
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Savannah Georgia
United States Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina
United States Stanford Cancer Center Stanford California
United States CCOP - Carle Cancer Center Urbana Illinois
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina
United States Lankenau Cancer Center at Lankenau Hospital Wynnewood Pennsylvania
United States York Cancer Center at Apple Hill Medical Center York Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Radiation Therapy Oncology Group National Cancer Institute (NCI), NRG Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 the 4-week value. The experimental arms (honey) were compared to the standard arm (supportive care). Baseline and 4 weeks from the start of treatment
Secondary Radiation Esophagitis-related Pain During Treatment as Measured During Treatment and 12 Weeks by the Numerical Rating Pain Scale (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). Baseline, weekly during treatment, and 12 weeks from the start of treatment
Secondary Dysphagia Via Daily Patient Log 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". Weekly during treatment and 12 weeks from the start of treatment
Secondary Quality of Life and Pain, as Measured by the EORTC QLQ-30 Global QOL Score and Pain Symptom Subscale at 4 and 12 Weeks 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. Baseline, 4 and 12 weeks from the start of treatment
Secondary Percentage of Participants With Radiation Esophagitis Grade 3-4 (CTCAE v. 4) 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. Up to 12 weeks from the start of treatment
Secondary Percent Change in Weight From Baseline to 4 Weeks Baseline and 4 weeks from the start of treatment
Secondary Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks) Baseline and 4 weeks from the start of treatment
Secondary Percentage of Patients Using Opioids 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. Baseline, 4 weeks, end of radiation treatment, and 12 weeks from the start of treatment
Secondary Adverse Events Associated With Manuka Honey Using CTCAE v4.0 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. Until 12 weeks from the start of treatment
Secondary 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) 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. Baseline and 4 weeks from the start of treatment
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