search
Back to results

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

Primary Purpose

Head and Neck Cancer, Oral Complications of Radiation Therapy, Pain

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lactobacillus brevis CD2 lozenge
placebo
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring pain, oral complications of radiation therapy, weight changes, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent verrucous carcinoma of the larynx, stage I squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the oropharynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the oropharynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the oropharynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage IVA squamous cell carcinoma of the larynx, stage IVA squamous cell carcinoma of the oropharynx, stage IVA verrucous carcinoma of the larynx, stage IVB squamous cell carcinoma of the larynx, stage IVB squamous cell carcinoma of the oropharynx, stage IVB verrucous carcinoma of the larynx, stage IVC squamous cell carcinoma of the larynx, stage IVC squamous cell carcinoma of the oropharynx, stage IVC verrucous carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I verrucous carcinoma of the oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage II verrucous carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage III verrucous carcinoma of the oral cavity, stage IVA squamous cell carcinoma of the lip and oral cavity, stage IVA verrucous carcinoma of the oral cavity, stage IVB squamous cell carcinoma of the lip and oral cavity, stage IVB verrucous carcinoma of the oral cavity, stage IVC squamous cell carcinoma of the lip and oral cavity, stage IVC verrucous carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent verrucous carcinoma of the oral cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Arm I

    Arm II

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    The AUC of the MTS score

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 1, 2012
    Last Updated
    August 4, 2017
    Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01545687
    Brief Title
    CD2 Lozenges in Preventing Acute Oral Mucositis in Patients With Head and Neck Cancer Receiving Radiotherapy and Chemotherapy
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer, Oral Complications of Radiation Therapy, Pain, Weight Changes
    Keywords
    pain, oral complications of radiation therapy, weight changes, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent verrucous carcinoma of the larynx, stage I squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the oropharynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the oropharynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the oropharynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage IVA squamous cell carcinoma of the larynx, stage IVA squamous cell carcinoma of the oropharynx, stage IVA verrucous carcinoma of the larynx, stage IVB squamous cell carcinoma of the larynx, stage IVB squamous cell carcinoma of the oropharynx, stage IVB verrucous carcinoma of the larynx, stage IVC squamous cell carcinoma of the larynx, stage IVC squamous cell carcinoma of the oropharynx, stage IVC verrucous carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I verrucous carcinoma of the oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage II verrucous carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage III verrucous carcinoma of the oral cavity, stage IVA squamous cell carcinoma of the lip and oral cavity, stage IVA verrucous carcinoma of the oral cavity, stage IVB squamous cell carcinoma of the lip and oral cavity, stage IVB verrucous carcinoma of the oral cavity, stage IVC squamous cell carcinoma of the lip and oral cavity, stage IVC verrucous carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent verrucous carcinoma of the oral cavity

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Arm II
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lactobacillus brevis CD2 lozenge
    Intervention Description
    Dissolved orally
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    Dissolved orally
    Primary Outcome Measure Information:
    Title
    The AUC of the MTS score
    Time Frame
    Up to 12 months
    Secondary Outcome Measure Information:
    Title
    OM measured by WHO OM scale, OMAS and CTCAE weekly during CRT
    Time Frame
    Up to 12 months
    Title
    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
    Title
    Quality of life as assessed by the FACT-HN
    Time Frame
    Up to 12 months
    Title
    Opioid requirement (frequency, morphine equivalent dose) as measured by daily OMDQ
    Time Frame
    Up to 12 months
    Title
    DFS at 12 months after treatment
    Time Frame
    at 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert C. Miller, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs