Pain Clinical Trial
Official 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
Verified date | August 2017 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI), NRG Oncology |
United States,
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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