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

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 2

Conditions: Esophagitis; Dysphagia; Lung Cancer; Pain

Treatments: Drug: Standard supportive care; Drug: Manuka honey in liquid form; Drug: Manuka honey in lozenge form

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT01262560

CDR0000690182

RTOG 1012

RTOG-1012

NCI-2011-02620 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

• 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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 3 patient groups

Supportive Care

Active Comparator group

Description:

Standard supportive care

Treatment:

Drug: Standard supportive care

Liquid Manuka Honey

Experimental group

Description:

Manuka honey in liquid form

Treatment:

Drug: Manuka honey in liquid form

Lozenge Manuka Honey

Experimental group

Description:

Manuka honey in lozenge form

Treatment:

Drug: Manuka honey in lozenge form