CD2 Lozenges in Preventing Acute Oral Mucositis in Patients With Head and Neck Cancer Receiving Radiotherapy and Chemotherapy

August 4, 2017 updated by: Alliance for Clinical Trials in Oncology

A Phase III, Randomized, Double-Blind Study of Lactobacillus Brevis CD2 Lozenges Versus Placebo in the Prevention of Acute Oral Mucositis (OM) in Patients With Head and Neck Cancer Receiving Concurrent Radiotherapy and Chemotherapy

RATIONALE: Lactobacillus bevis CD2 lozenge may help prevent symptoms of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy. This therapy may improve the quality of life of patients with head and neck cancer.

PURPOSE: This phase III trial studies how well Lactobacillus bevis CD2 lozenge prevents oral mucositis in patients with head and neck cancer who are being treated with cisplatin and radiation therapy. These results will be compared to results in patients using placebo lozenges.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To determine whether Lactobacillus brevis CD2 lozenges are effective in reducing oral mucositis (OM)-related pain in patients undergoing chemoradiotherapy (CRT) for head and neck squamous cell carcinoma, as measured by the area under the curve (AUC) of Mouth and Throat Soreness (MTS) score (Oral Mucositis Daily Questionnaire [OMDQ] question 2) measured daily during CRT and daily for 4 weeks after completion of CRT.

Secondary

  • To assess whether L. brevis CD2 lozenges reduce OM as assessed by the provider using the WHO OM scale, Oral Mucositis Assessment Scale (OMAS), and Common Terminology Criteria Adverse Events (CTCAE).
  • To assess whether L. brevis CD2 lozenges reduce the impact of OM on the ability to swallow, drink, eat, talk, and sleep, as assessed by the MTS-Activity Limitations (MTS-AL).
  • To assess whether L. brevis CD2 lozenges improve quality of life, as assessed by the Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN).
  • To assess whether L. brevis CD2 lozenges reduce opioid requirements.
  • To assess whether L. brevis CD2 lozenges improve radiotherapy compliance.
  • To assess whether L. brevis CD2 lozenges reduce weight loss and the need for a feeding tube.
  • To assess whether L. brevis CD2 lozenges affect disease-free survival (DFS) at 12 months after treatment.
  • To evaluate the effect of L. brevis CD2 lozenges on salivary biomarkers, including metabonomic and inflammatory markers, as measured at baseline, week 3 of CRT, and during the last week of CRT. (exploratory)

OUTLINE: This is a multicenter, randomized, placebo-controlled, double-blind study. Patients are stratified according to primary disease site (oral cavity/oropharynx vs nasopharynx vs hypopharynx/larynx), context of chemoradiotherapy (CRT) (definitive vs post-operative), cisplatin schedule (every 3 weeks [100 mg/m^2] vs every week [30-40 mg/m^2]), and use of intensity-modulated radiotherapy (IMRT) (yes vs no). Patients are randomized to 1 of 2 treatment regimens.

  • Arm I: Patients dissolve in mouth 1 lozenge of Lactobacillus brevis CD2 every 2-3 hours (total of 6 per day) daily during CRT (comprising cisplatin and radiotherapy [RT]) and for 4 weeks after, including weekends.
  • Arm II: Patients dissolve in mouth 1 lozenge of placebo every 2-3 hours (total of 6 per day) daily during CRT and for 4 weeks after, including weekends.

Patients complete questionnaires about their quality of life and pain at baseline and daily during study treatment.

Saliva is collected from some patients before starting RT, during week 3 of RT, and during the last week of RT for NMR-spectroscopic metabolomic analysis and future cytokine analysis.

After completion of study treatment, patients are followed up at 12 months.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
  • Planned course of definitive or post-operative radiotherapy (RT) to a total dose of ≥ 60 Gy using 1.8 to 2.0 Gy per fraction
  • At least one third of the oral cavity mucosa must be included in the RT fields, as estimated by the treating radiation oncologist
  • Planned concurrent administration of cisplatin chemotherapy (either 100 mg/m^2 every 3 weeks or 30-40 mg/m^2 every week)

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0, 1, or 2
  • Hemoglobin ≥ 10.0 g/dL
  • White blood cell (WBC) ≥ 3,500 x10^9/L
  • Absolute neutrophil count (ANC) ≥ 1,500 x10^9/L
  • Platelet count ≥ 100,000 x10^9/L
  • Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Willing to provide saliva samples for correlative research purposes (first 50 patients)
  • Not pregnant or nursing
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential
  • Men or women of childbearing potential must employ adequate contraception
  • No co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • No current untreated oral candidiasis, oral herpes simplex virus (HSV) infection, or oral mucositis

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No split-course RT planned
  • No prior head and neck RT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I
Patients dissolve in mouth 1 lozenge of Lactobacillus bevis CD2 every 2-3 hours (total of 6 per day) daily during CRT (comprising cisplatin and radiotherapy [RT]) and for 4 weeks after, including weekends.
Dietary supplement: Lactobacillus brevis CD2 lozenge
Dissolved orally
PLACEBO_COMPARATOR: Arm II
Patients dissolve in mouth 1 lozenge of placebo every 2-3 hours (total of 6 per day) daily during CRT and for 4 weeks after, including weekends.
Other: placebo
Dissolved orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The AUC of the MTS score
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
OM measured by WHO OM scale, OMAS and CTCAE weekly during CRT
Time Frame: Up to 12 months
Up to 12 months
Impact of OM on the ability to swallow, drink, eat, talk, and sleep, as assessed by the MTS-AL
Time Frame: Up to 12 months
Up to 12 months
Quality of life as assessed by the FACT-HN
Time Frame: Up to 12 months
Up to 12 months
Opioid requirement (frequency, morphine equivalent dose) as measured by daily OMDQ
Time Frame: Up to 12 months
Up to 12 months
DFS at 12 months after treatment
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (ESTIMATE)

March 7, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 4, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N11C5
  • NCCTG-N11C5
  • CDR0000727295 (REGISTRY: PDQ (Physician Data Query))
  • NCI-2012-00692 (REGISTRY: CTRP (Clinical Trials Reporting System))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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