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

NCT01545687 | Withdrawn Phase 3

• 4 other identifiers: N11C5NCCTG-N11C5CDR0000727295NCI-2012-00692
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The AUC of the MTS score

  Up to 12 months

Secondary Outcomes (5)

• OM measured by WHO OM scale, OMAS and CTCAE weekly during CRT

  Up to 12 months

• Impact of OM on the ability to swallow, drink, eat, talk, and sleep, as assessed by the MTS-AL

  Up to 12 months

• Quality of life as assessed by the FACT-HN

  Up to 12 months

• Opioid requirement (frequency, morphine equivalent dose) as measured by daily OMDQ

  Up to 12 months

• DFS at 12 months after treatment

  at 12 months

Study Arms (2)

Arm I

EXPERIMENTAL

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

Arm II

PLACEBO COMPARATOR

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

Interventions

Lactobacillus brevis CD2 lozenge DIETARY_SUPPLEMENT

Dissolved orally

Arm I

placebo OTHER

Dissolved orally

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Head and Neck Neoplasms; Pain; Body Weight Changes; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Robert C. Miller, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 7, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2017
• Last Updated: August 8, 2017

Record last verified: 2017-08