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DysphagiaPhase 2NCT01262560

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

A Phase 2 study testing Manuka honey in liquid form, Manuka honey in lozenge form and Standard supportive care in people with Dysphagia and Lung Cancer, run by Radiation Therapy Oncology Group at 59 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dysphagia, Lung Cancer, Pain
What is being tested?
Manuka honey in liquid form, Manuka honey in lozenge form and Standard supportive care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
59 sitesUnited States
Study dates
Feb 2012to Nov 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Payson Center for Cancer Care at Concord Hospital

    Concord, New Hampshire, 03301

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Seacoast Cancer Center at Wentworth - Douglass Hospital

    Dover, New Hampshire, 03820

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

  • Parkview Regional Cancer Center at Parkview Health

    Fort Wayne, Indiana, 46805

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0361

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Hawaii Medical Center - East

    Honolulu, Hawaii, 96817

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Trinity CancerCare Center

    Minot, North Dakota, 58701

  • Providence Cancer Center at Providence Hospital

    Mobile, Alabama, 36608

  • Cancer Center at Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Florida Cancer Center - Palatka

    Palatka, Florida, 32177

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Parma Community General Hospital

    Parma, Ohio, 44129

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61615-7827

  • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

    Pinehurst, North Carolina, 28374

  • Rex Cancer Center at Rex Hospital

    Raleigh, North Carolina, 27607

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

    Savannah, Georgia, 31405

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Stanford Cancer Center

    Stanford, California, 94305-5824

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • York Cancer Center at Apple Hill Medical Center

    York, Pennsylvania, 17405

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
Manuka honey in liquid form, Manuka honey in lozenge form, Standard supportive care
Keywords
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
Medical subject headings
Deglutition Disorders, Lung Neoplasms, Pain, Esophagitis, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manuka honey in liquid formDrug

    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 formDrug

    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 careDrug

    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.

    1. A compound containing viscous lidocaine and magnesium aluminum oxide (Maalox®);
    2. Liquid or solid oxycodone, 5-10 mg, every 3 hours as needed.
Study groups in NCT01262560
Study groupRoleWhat they receive
Supportive CareActive comparatorStandard supportive care
Receives: Drug: Standard supportive care
Liquid Manuka HoneyExperimentalManuka honey in liquid form
Receives: Drug: Manuka honey in liquid form
Lozenge Manuka HoneyExperimentalManuka honey in lozenge form
Receives: Drug: Manuka honey in lozenge form

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline and 4 weeks from the start of treatment

Secondary outcomes (9)

  1. 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).

    Measured: Baseline, weekly during treatment, and 12 weeks from the start of treatment

  2. 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".

    Measured: Weekly during treatment and 12 weeks from the start of treatment

  3. 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.

    Measured: Baseline, 4 and 12 weeks from the start of treatment

  4. 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.

    Measured: Up to 12 weeks from the start of treatment

  5. Percent Change in Weight From Baseline to 4 Weeks

    Measured: Baseline and 4 weeks from the start of treatment

  6. Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks)

    Measured: Baseline and 4 weeks from the start of treatment

  7. 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.

    Measured: Baseline, 4 weeks, end of radiation treatment, and 12 weeks from the start of treatment

  8. 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.

    Measured: Until 12 weeks from the start of treatment

  9. 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.

    Measured: Baseline and 4 weeks from the start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2010 (estimated)
  2. Study startFeb 2012
  3. Primary completionFeb 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01262560
Sponsor's protocol ID
RTOG 1012
Other IDs
RTOG-1012, CDR0000690182, NCI-2011-02620
Status last verified
Aug 2017
First submitted
16 Dec 2010
Last updated
31 Aug 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Manuka honey in liquid form, Manuka honey in lozenge form and Standard supportive care in people with Dysphagia and Lung Cancer, run by Radiation Therapy Oncology Group at 59 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS) (time frame: Baseline and 4 weeks from the start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01262560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.

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