CD2 Lozenges in Preventing Acute Oral Mucositis in Patients With Head and Neck Cancer Receiving Radiotherapy and Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01545687|
Recruitment Status : Withdrawn
First Posted : March 7, 2012
Last Update Posted : August 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Oral Complications of Radiation Therapy Pain Weight Changes||Dietary Supplement: Lactobacillus brevis CD2 lozenge Other: placebo||Phase 3|
- 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.
- 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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||April 2012|
|Estimated Primary Completion Date :||December 2017|
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
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.
- The AUC of the MTS score [ Time Frame: Up to 12 months ]
- OM measured by WHO OM scale, OMAS and CTCAE weekly during CRT [ Time Frame: 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 ]
- Quality of life as assessed by the FACT-HN [ Time Frame: Up to 12 months ]
- Opioid requirement (frequency, morphine equivalent dose) as measured by daily OMDQ [ Time Frame: Up to 12 months ]
- DFS at 12 months after treatment [ Time Frame: at 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545687
|Principal Investigator:||Robert C. Miller, MD||Mayo Clinic|