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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Dysphagia, Lung Cancer, Pain, Esophagitis

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Trial Information

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Radiation esophagitis-related pain, 4 weeks from the start of treatment as measured by the Numerical Rating Pain Scale for pain on swallowing (NRPS)

Outcome Time Frame:

Baseline and 4 weeks from the start of treatment

Safety Issue:

No

Principal Investigator

Lawrence B. Berk, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tampa General Hospital, University of South Florida

Authority:

United States: Food and Drug Administration

Study ID:

RTOG 1012

NCT ID:

NCT01262560

Start Date:

February 2012

Completion Date:

Related Keywords:

  • Dysphagia
  • Lung Cancer
  • Pain
  • Esophagitis
  • pain
  • dysphagia
  • recurrent non-small cell lung cancer
  • stage IA non-small cell lung cancer
  • stage IB non-small cell lung cancer
  • stage IIA non-small cell lung cancer
  • stage IIB non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • extensive stage small cell lung cancer
  • limited stage small cell lung cancer
  • recurrent small cell lung cancer
  • esophagitis
  • Deglutition Disorders
  • Esophagitis
  • Lung Neoplasms

Name

Location

Cleveland Clinic Cancer CenterCleveland, Ohio  44195
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Mercy Cancer Center at Mercy Medical CenterCanton, Ohio  44708
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Cape Cod HospitalHyannis, Massachusetts  02601
University of Texas Medical BranchGalveston, Texas  77555-1329
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Parma Community General HospitalParma, Ohio  44129
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
OSF St. Francis Medical CenterPeoria, Illinois  61637
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Highland Hospital of RochesterRochester, New York  14620
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Cancer Center at Ball Memorial HospitalMuncie, Indiana  47303
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Stanford Cancer CenterStanford, California  94305-5824
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405
York Cancer Center at Apple Hill Medical CenterYork, Pennsylvania  17405
St. Joseph Cancer CenterBellingham, Washington  98225
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Parkview Regional Cancer Center at Parkview HealthFort Wayne, Indiana  46805
Elliot Regional Cancer Center at Elliot HospitalManchester, New Hampshire  03103
Pardee Memorial HospitalHendersonville, North Carolina  28791
Rex Cancer Center at Rex HospitalRaleigh, North Carolina  27607
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Duke Cancer InstituteDurham, North Carolina  27710
Florida Cancer Center - PalatkaPalatka, Florida  32177
Providence Cancer Center at Providence HospitalMobile, Alabama  36608
Hawaii Medical Center - EastHonolulu, Hawaii  96817
Trinity CancerCare CenterMinot, North Dakota  58701
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Piedmont Fayette HospitalFayetteville, Georgia  30214
Northeast Radiation Oncology CenterDunmore, Pennsylvania  18512
Payson Center for Cancer Care at Concord HospitalConcord, New Hampshire  03301
Seacoast Cancer Center at Wentworth - Douglass HospitalDover, New Hampshire  03820
Adams Cancer CenterGettysburg, Pennsylvania  17325
Cherry Tree Cancer CenterHanover, Pennsylvania  17331