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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01262560
First received: December 16, 2010
Last updated: August 29, 2017
Last verified: August 2017
Results First Received: December 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Dysphagia
Lung Cancer
Pain
Esophagitis
Interventions: Drug: Manuka honey in liquid form
Drug: Manuka honey in lozenge form
Drug: Standard supportive care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Supportive Care Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
Liquid Manuka Honey Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
Lozenge Manuka Honey Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.

Participant Flow:   Overall Study
    Supportive Care   Liquid Manuka Honey   Lozenge Manuka Honey
STARTED   53   54   56 
COMPLETED   53 [1]   53 [1]   54 [1] 
NOT COMPLETED   0   1   2 
Protocol Violation                0                1                2 
[1] Randomized eligible patients who received protocol treatment.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All eligible patients

Reporting Groups
  Description
Supportive Care Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
Liquid Manuka Honey Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
Lozenge Manuka Honey Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
Total Total of all reporting groups

Baseline Measures
   Supportive Care   Liquid Manuka Honey   Lozenge Manuka Honey   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   53   54   160 
Age 
[Units: Years]
Median (Full Range)
 65 
 (45 to 85) 
 66 
 (37 to 83) 
 65 
 (47 to 83) 
 65 
 (37 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      27  50.9%      24  45.3%      23  42.6%      74  46.3% 
Male      26  49.1%      29  54.7%      31  57.4%      86  53.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Radiation Esophagitis-related Pain During Treatment as Measured During Treatment and 12 Weeks by the Numerical Rating Pain Scale (NRPS)   [ Time Frame: Baseline, weekly during treatment, and 12 weeks from the start of treatment ]

3.  Secondary:   Dysphagia Via Daily Patient Log   [ Time Frame: Weekly during treatment and 12 weeks from the start of treatment ]

4.  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   [ Time Frame: Baseline, 4 and 12 weeks from the start of treatment ]

5.  Secondary:   Percentage of Participants With Radiation Esophagitis Grade 3-4 (CTCAE v. 4)   [ Time Frame: Up to 12 weeks from the start of treatment ]

6.  Secondary:   Percent Change in Weight From Baseline to 4 Weeks   [ Time Frame: Baseline and 4 weeks from the start of treatment ]

7.  Secondary:   Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks)   [ Time Frame: Baseline and 4 weeks from the start of treatment ]

8.  Secondary:   Percentage of Patients Using Opioids   [ Time Frame: Baseline, 4 weeks, end of radiation treatment, and 12 weeks from the start of treatment ]

9.  Secondary:   Adverse Events Associated With Manuka Honey Using CTCAE v4.0   [ Time Frame: Until 12 weeks from the start of treatment ]

10.  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)   [ Time Frame: Baseline and 4 weeks from the start of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org



Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01262560     History of Changes
Other Study ID Numbers: RTOG 1012
RTOG-1012
CDR0000690182
NCI-2011-02620 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: December 16, 2010
Results First Received: December 13, 2016
Last Updated: August 29, 2017