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



Status:Recruiting
Conditions:Lung Cancer, Cancer, Chronic Pain, Gastrointestinal
Therapuetic Areas:Gastroenterology, Musculoskeletal, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/19/2013
Start Date:February 2012

Use our guide to learn which trials are right for you!

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


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.


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
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 ALA-30 and Pain Subscale, and PRO-CTCAE) periodically during study
treatment.

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

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:

- Able to swallow thick liquids prior to treatment

- Able 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
We found this trial at
59
sites
3301 Squalicum Parkway
Bellingham, Washington 98225
(360) 788-8222
St. Joseph Cancer Center The PeaceHealth St. Joseph Cancer Center offers a full-range of services...
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
1200 Old York Road
Abington, Pennsylvania 19001
(215) 481-2400
Rosenfeld Cancer Center at Abington Memorial Hospital As one of the most trusted cancer centers...
?
mi
from
Abington, PA
Click here to add this to my saved trials
200 Hawthorne Lane
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
100 North Academy Ave
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
?
mi
from
Danville, PA
Click here to add this to my saved trials
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
?
mi
from
Galveston, TX
Click here to add this to my saved trials
1920 Libal Street
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
One Medical Center Drive
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
800 Rose St
Lexington, Kentucky 40536
(859) 257-4488
Lucille P. Markey Cancer Center at University of Kentucky The Markey Cancer Center was founded...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
600 Zeagler Drive
Palatka, Florida 32177
?
mi
from
Palatka, FL
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
660 S Euclid Ave #8100
Saint Louis, Missouri 63110
(314) 362-5196
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis The Alvin J. Siteman Cancer Center...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
?
mi
from
Bryn Mawr, PA
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
11100 Euclid Avenue
Cleveland, Ohio 44106
216.844.8797
Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
Cleveland Clinic Cancer Center at Fairview Hospital Fairview Hospital is a 488-bed hospital located at...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Concord, NH
Click here to add this to my saved trials
?
mi
from
Dover, NH
Click here to add this to my saved trials
Dunmore, Pennsylvania 18512
?
mi
from
Dunmore, PA
Click here to add this to my saved trials
20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
?
mi
from
Durham, NC
Click here to add this to my saved trials
5008 Brittonfield Parkway
East Syracuse, New York 13057
(315) 472-7504
CCOP - Hematology-Oncology Associates of Central New York Hematology/Oncology Associates of CNY (HOACNY) has participated...
?
mi
from
East Syracuse, NY
Click here to add this to my saved trials
1255 Hwy 54 W,
Fayetteville, Georgia 30214
(770) 719-7000
Piedmont Fayette Hospital Piedmont Fayette Hospital, a 172-bed community hospital, is among the most highly-ranked...
?
mi
from
Fayetteville, GA
Click here to add this to my saved trials
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
40 V-Twin Drive
Gettysburg, Pennsylvania 17325
(717) 339-2640
Adams Cancer Center Every day across central Pennsylvania, the people of WellSpan Health work together...
?
mi
from
Gettysburg, PA
Click here to add this to my saved trials
1726 Shawano Ave
Green Bay, Wisconsin 54303
(920) 498-4200
Saint Mary's Hospital Our team of dedicated physicians, nurses and staff offer a broad spectrum...
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
773 Cherry Tree Ct
Hanover, Pennsylvania 17331
(717) 633-9573
?
mi
from
Hanover, PA
Click here to add this to my saved trials
800 N Justice St
Hendersonville, North Carolina 28791
(828) 696-1000
Pardee Memorial Hospital Pardee Hospital is a not-for-profit community hospital founded in 1953 and is...
?
mi
from
Hendersonville, NC
Click here to add this to my saved trials
2226 Liliha St
Honolulu, Hawaii 96817
(808) 547-6011
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
1301 Punchbowl Street
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Cancer Institute at Queen's Medical Center The Queen
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Hyannis, Massachusetts 02601
?
mi
from
Hyannis, MA
Click here to add this to my saved trials
Independence, Ohio 44131
?
mi
from
Independence, OH
Click here to add this to my saved trials
800 Prudential Drive
Jacksonville, Florida 32207
904.202.2000
Baptist Cancer Institute - Jacksonville For more than 20 years, health care consumers have named...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Long Branch, New Jersey
?
mi
from
Long Branch, NJ
Click here to add this to my saved trials
Manchester, New Hampshire 03103
?
mi
from
Manchester, NH
Click here to add this to my saved trials
90 Brick Rd
Marlton, New Jersey 08053
(856) 355-6000
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Virtua collaborates with Fox...
?
mi
from
Marlton, NJ
Click here to add this to my saved trials
6780 Mayfield Rd
Mayfield Heights, Ohio 44124
(440) 312-4569
Hillcrest Cancer Center at Hillcrest Hospital Hillcrest Hospital opened on November 23, 1968, in Mayfield...
?
mi
from
Mayfield Heights, OH
Click here to add this to my saved trials
Minot, North Dakota 58701
?
mi
from
Minot, ND
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
?
mi
from
Muncie, IN
Click here to add this to my saved trials
4701 Ogletown-Stanton Road
Newark, Delaware 19713
302-623-4450
CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
?
mi
from
Newark, DE
Click here to add this to my saved trials
Paoli, Pennsylvania 19301
?
mi
from
Paoli, PA
Click here to add this to my saved trials
?
mi
from
Parma, OH
Click here to add this to my saved trials
2809 Denny Ave
Pascagoula, Mississippi 39581
228-809-5251
Regional Cancer Center at Singing River Hospital The Regional Cancer Center team at Singing River...
?
mi
from
Pascagoula, MS
Click here to add this to my saved trials
530 NE Glen Oak Ave
Peoria, Illinois 61637
(309) 655-2000
OSF St. Francis Medical Center OSF Saint Francis Medical Center, licensed for 616 beds and...
?
mi
from
Peoria, IL
Click here to add this to my saved trials
155 Memorial Drive P O Box 3000
Pinehurst, North Carolina 28374
(910) 715-1000
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center FirstHealth Moore Regional Hospital is a Comprehensive...
?
mi
from
Pinehurst, NC
Click here to add this to my saved trials
Raleigh, North Carolina 27607
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rochester, New York 14620
?
mi
from
Rochester, NY
Click here to add this to my saved trials
1200 6th Ave N
Saint Cloud, Minnesota 56303
(320) 252-5131
CentraCare Clinic - River Campus CentraCare Health is a not-for-profit health care system that provides...
?
mi
from
Saint Cloud, MN
Click here to add this to my saved trials
607 S. New Ballas Road
Saint Louis, Missouri 63141
(314) 251-4800
David C. Pratt Cancer Center at St. John's Mercy Many forms of cancer are more...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Savannah, GA
Click here to add this to my saved trials
101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Gibbs Cancer Center is a nationally...
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
875 Blake Wilbur Dr
Stanford, California 94305
(650) 498-6000
Stanford University Cancer Institute The Stanford Cancer Institute (SCI) focuses the world-class expertise of more...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
?
mi
from
Urbana, IL
Click here to add this to my saved trials
100 E Lancaster Ave
Wynnewood, Pennsylvania 19096
(484) 476-2000
Lankenau Cancer Center at Lankenau Hospital At Lankenau we pride ourselves on the breadth of...
?
mi
from
Wynnewood, PA
Click here to add this to my saved trials
25 Monument Rd. Suite 194
York, Pennsylvania 17403
(717) 741-8100
York Cancer Center at Apple Hill Medical Center Located on the Apple Hill Medical Campus,...
?
mi
from
York, PA
Click here to add this to my saved trials