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Mouth gel curbs oral pain after cancer treatment
NEW YORK (Reuters Health) - An oral gel containing the anesthetic tetracaine reduces mouth soreness caused by radiation treatment for cancer of the head and neck, according to results of a study.

Mouth inflammation and sores, or mucositis, are a common and serious side effect of radiation therapy for head and neck cancer patients. Mucositis can lead to problems with drinking and eating, as well as infection.

"In our opinion," the authors conclude, "local application of anesthetic agents should be encouraged, but larger prospective randomized trials are required to confirm these data."

SOURCE: International Journal of Radiation Oncology, Biology and Physics February 1, 2006.
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Intravenous Glutamine May Improve Oral Mucositis in Patients with Head and Neck Cancer (9th August 2006)
NEW YORK (Reuters Health) - Among patients with advanced head and neck cancer treated with chemotherapy and radiation therapy, intravenous treatment with a derivative of the amino acid glutamine may reduce the severity of oral mucositis. These results were published in the International Journal of Radiation Oncology Biology Physics.

Oral mucositis refers to inflammation of the oral mucosa (lining of the mouth) that results from chemotherapy or radiation therapy. Symptoms may include redness, swelling, and ulceration. When oral mucositis is severe, patients cannot swallow food or liquid and often have to be given nutrients through a vein. In addition, oral mucositis can cause severe pain, increase the risk of infection, and may limit a patient’s ability to tolerate further treatment.

Glutamine is an amino acid that plays a role in cellular repair. To evaluate the safety and effectiveness of intravenous administration of a derivative of glutamine—L-alanyl-L-glutamine—researchers in Argentina conducted a clinical trial among 29 patients with advanced head and neck cancer. Half the patients received intravenous L-alanyl-L-glutamine and half the patients received intravenous saline (the placebo).

  • Severe oral mucositis developed in 14% of patients treated with L-alanyl-L-glutamine and 67% of patients treated with the placebo.
  • A feeding tube was required by 14% of patients treated with L-alanyl-L-glutamine and 60% of patients treated with the placebo.
  • Patients treated with L-alanyl-L-glutamine reported less pain than patients treated with the placebo.
  • L-alanyl-L-glutamine did not appear to produce any adverse side effects.

The researchers conclude that intravenous treatment with the glutamine derivative L-alanyl-L-glutamine may reduce the severity of oral mucositis in patients with advanced head and neck cancer.

Reference: Cerchietti LCA, Navigante AH, Lutteral MA et al. Double-Blinded, Placebo-controlled Trial on Intravenous L-alanyl-L-glutamine in the Incidence of Oral Mucositis Following Chemoradiotherapy in Patients with Head and Neck Cancer. International Journal of Radiation Oncology Biology Physics. 2006;65:1330-1337.

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American Society for Radiation Oncology (ASTRO) 2016 Annual Meeting. Abstract LBA-3. Presented September 27.

Magic Mouthwash Really Works, Says Phase 3 Trial Lidocaine-Based Rinse for Oral Mucositis
Nick Mulcahy September 27, 2016

Although magic mouthwash might not fulfill science fiction author Arthur C. Clarke's notion that "any sufficiently advanced technology is indistinguishable from magic," the stuff does in fact work in cancer patients, according to the results of a large phase 3 trial.

"Magic mouthwash" is a term that encompasses as many as 50 varieties of lidocaine-based rinses that are widely used for oral mucositis pain. However, no large, multicentered, randomized controlled trial has been conducted to evaluate efficacy, until now.

New results show that a lidocaine-based mouthwash is effective in reducing radiotherapy-related oral mucositis pain, concludes a team led by Robert Miller, MD, of Mayo Clinic, Jacksonville, Florida.

"The study confirms what we thought — that it works," Dr Miller told Medscape Medical News here at the American Society for Radiation Oncology (ASTRO) 2016 Annual Meeting, where study results were presented.

After patients rinsed once with the mouthwash, there was a 35% reduction in pain over a 4-hour period in comparison with placebo, said Dr Miller.

"It's always good to see what we are using has a solid scientific basis," said Thomas Galloway, MD, a radiation oncologist at Fox Chase Cancer Center in Philadelphia, Pennsylvania, who was not involved in the study.

Always good to see what we are using has a solid scientific basis. Dr Thomas Galloway

The magic mouthwash in the new study consisted of a diphenhydramine/lidocaine/antacid (DLA) preparation that is used at Mayo Clinic sites. The three agents in the mix are the most commonly used elements in the many manifestations of the mouth rinse, said Dr Miller.

Oral mucositis is a major cause of morbidity during radiotherapy for head and neck cancers, he explained.

Painful mucositis impairs the ability to eat and drink, affects quality of life, and can cause interruptions of cancer treatment to enable healing, he said.

Various approaches to minimize these side effects have been tried, including oral cryotherapy, low-level laser therapy, and rinses containing a mucoadhesive hydrogel.

Magic mouthwashes containing lidocaine are also widely used, but the lack of robust evidence of efficacy led the American Academy of Nursing to issue a 2015 advisory against their use as part of the Choosing Wisely campaign. "Don't use mixed medication mouthwash, commonly termed 'magic mouthwash,' to prevent or manage cancer treatment–induced oral mucositis," reads the statement.

Study Details

In the new study, patients underwent definitive head and neck radiotherapy (> 45 Gy) and had oral mucositis pain rated at least 4 on a scale of 1 to 10 in a commonly used pain questionnaire.

A group of 275 patients were randomly allocated individually to blindly receive one of three agents: magic mouthwash (DLA), doxepin oral rinse, or a placebo rinse.

Doxepin has previously been shown to reduce oral mucositis pain in another sizeable phase 3 trial led by Dr Miller, as reported by Medscape Medical News in 2012.

After rinsing, the patients then filled out the pain questionnaire at intervals out to 4 hours.

The primary endpoint was pain reduction, as measured by the area under the curve (AUC) of the pain scale over the 4 hours following a single dose of the rinse.

Analysis of the primary endpoint revealed significant differences in mean AUC reduction in pain between DLA and placebo (11.7 vs 8.7, P = .004). The numbers translated into the above-mentioned 35% reduction in pain over the 4-hour test period, said Dr Miller.

Doxepin was also significantly effective for the same measure compared to placebo (11.9 vs. 8.7, P = .01).

"Both agents were significantly better than placebo," said Dr Miller.

The new trial was not powered to compare DLA and doxepin, pointed out Dr Miller. Thus, the results simply indicate that both DLA and doxepin were effective in the treatment of the pain.

Only 15% of patients who received doxepin used additional analgesics at 4 hours post oral rinse compared with 28% in the placebo arm (P < .05). However, there was no significant difference between DLA and placebo for this measure (19% vs 28%, P = .22).

Fox Chases' Dr Galloway said that the results were "expected," given the fact that he sees "a lot of patients who feel better" after a rinse with magic mouthwash. The rinse used at Fox Chase is very similar to the study formulation, he added.

Dr Galloway also observed that new rinses for oral mucositis appear in the marketplace regularly. "I don't think we know what product works best," he told Medscape Medical News.

Dr Miller has financial ties to Tekcapital and Belluscura. Dr Galloway has disclosed no relevant financial relationships.

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