Preventive effects of amino-acid-rich elemental diet Elental® on chemotherapy-induced oral mucositis in patients with colorectal cancer: a prospective pilot study

Osuga, Yutaka; Ishibashi, Nobuya; Yamaguchi, Keiko; Uchida, Shinichi; Kamei, Hideki; Nakayama, Goichi; Hirakawa, Hiroaki; Tanigawa, Masahiko; Akagi, Yoshito

doi:10.1007/s00520-015-2844-0

Cited by 23 publications

(31 citation statements)

References 21 publications

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“…Current studies have shown that amino acids themselves can protect the mucosa and have anti-inflammatory effects [ 18 , 26 ]. The administration of an ED during cancer chemotherapy has been reported to have the potential prevent OM [ 17 , 21 ]. Chemotherapy damages DNA through the production of reactive oxygen species, the induction of apoptosis through the upregulation of the expression of intracellular molecules, and the production of several cytokines, such as IL-1β, IL-6, and TNF-α [ 27 , 28 ].…”

Section: Discussionmentioning

confidence: 99%

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The effect of an elemental diet on oral mucositis of esophageal cancer patients treated with DCF chemotherapy: a multi-center prospective feasibility study (EPOC study)

Tanaka

Ueno²,

Yoshida

et al. 2018

Esophagus

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PurposeOral mucositis (OM) is one of the most uncomfortable adverse events experienced by cancer patients undergoing chemotherapy. Previous reports have revealed that the oral administration of an elemental diet (ED) may prevent OM. However, the incidence of OM has not been accurately determined by specialized diagnostic methods and the effects of an ED on OM remain unclear. We investigated the dose that could feasibly be administered and its effects with regard to the suppression of OM in esophageal cancer patients undergoing chemotherapy.MethodsWe performed a prospective multi-center feasibility study of the administration of an ED (160 g/day) with 2 cycles of docetaxel/cisplatin/5-FU (DCF) chemotherapy. We assessed compliance to the ED for 49 days and the incidence of OM according to the amount of the ED that was orally administered. The incidence of OM was graded by a dental specialist who was experienced in dental oncology using a central OM review system.ResultsFourteen of 20 patients (70%) were able to complete the orally administered ED (160 g/day) during the course of chemotherapy. Three patients (15%) could not take the ED orally for 9, 14, and 21 days, respectively, while 1 patient (5%) took the ED orally at an average dose of 80 g/day for 35 days. The remaining 2 patients (10%) could not take the 80 g/day dose for 11 and 12 days, respectively. The incidence of grade ≥ 2 OM in the ED completion group (15.4%, 2 of 13 patients) was significantly lower than that in the non-completion group (66.7%, 4 of 6 patients) (p = 0.046).ConclusionsAn ED might be a one of the test treatment to reduce the incidence of OM in esophageal cancer patients treated with DCF and should be evaluated in further randomized study.Clinical trialThe date of submission: Dec 08th, 2017.Electronic supplementary materialThe online version of this article (10.1007/s10388-018-0620-1) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

“…According to the Ogata et al’s report [ 21 ], the setting dose of an ED during chemotherapy for colon cancer was 1 pack (80 g)/day, but the average amount of the ED that was able to be taken was 51.7%. This study is a triplet regimen for esophageal cancer, so the setting dose of an ED is 2 packs (160 g)/day.…”

Section: Methodsmentioning

confidence: 99%

The effect of an elemental diet on oral mucositis of esophageal cancer patients treated with DCF chemotherapy: a multi-center prospective feasibility study (EPOC study)

Tanaka

Ueno²,

Yoshida

et al. 2018

Esophagus

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“…Patients who received at least one dose of azulene or Elental were included in the analyses. Based on the results of previous studies (28)(29)(30), the difference between the incidences of oral mucositis for two arms was assumed to be 35% (the incidence for the azulene arm and Elental Arm being 50 and 15%, respectively). with one-sided type I error=0.1 and type II error=0.2, it was necessary to include 16 patients in each arm.…”

Section: Assessmentmentioning

confidence: 99%

The amino acid-rich elemental diet Elental® preserves lean body mass during chemo- or chemoradiotherapy for esophageal cancer

et al. 2016

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Chemo (chemoradio) therapy can induce oral mucositis and change body composition in patients with esophageal cancer. The impact of the amino acid-rich elemental diet Elental® on oral mucositis and changes in body composition during chemo (chemoradio) therapy is unclear. Thus, the purpose of the present study was to examine the preventive effects of Elental on oral mucositis and sarcopenia progression during chemo (chemoradio) therapy for esophageal cancer. Patients were randomized to receive either azulene oral rinse (Arm 1) or Elental (Arm 2) during the treatment cycle (4 weeks). The incidence of oral mucositis and other adverse events was evaluated weekly. Body composition pre- and post-treatment cycle was measured by bioelectric impedance analysis. Thirty‑three patients (17 azulene and 16 Elental) completed the study, and the groups were well matched. Elental tended to reduce the incidence of oral mucositis (Arm 1, 23.5% and Arm 2, 12.5%), but there was no statistically significant difference between the groups. The average body mass index (BMI) and body fat mass decreased significantly in both groups after the treatments. Lean body mass (LBM) was reduced in Arm 1, but was increased in Arm 2 after the treatment; the relative change of LBM after the treatment was significant between Arm 1 and Arm 2 (P=0.007). This study revealed that Elental nutrition could counteract sarcopenia development during chemoradiotherapy for esophageal cancer. These properties may lead to improvement of the quality of life and clinical outcome of esophageal cancer patients treated with chemo (chemoradio) therapy (Clinical Trial Registry ID: UMIN 000007960).

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“…The incidence of grade ≥ 2 OM was the highest in the glutamine group, followed by the control group, and the least in the glutamine plus ED group (p = 0.04). ED was found to be effective also in a cohort study of 22 colorectal cancer patients treated with 5-fluorouracil (FU)-based chemotherapy [60].…”

Section: Elemental Diet (Po): Solid Cancers Ct-prevention Guideline:mentioning

confidence: 99%

Systematic review of natural and miscellaneous agents for the management of oral mucositis in cancer patients and clinical practice guidelines—part 1: vitamins, minerals, and nutritional supplements

Yarom

Hovan²,

Bossi

et al. 2019

Support Care Cancer

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Purpose To update the clinical practice guidelines for the use of natural and miscellaneous agents for the prevention and/or treatment of oral mucositis (OM). Methods A systematic review was conducted by the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer / International Society of Oral Oncology (MASCC/ISOO). The body of evidence for each intervention, in each cancer treatment setting, was assigned an evidence level. The findings were added to the database used to develop the 2014 MASCC/ ISOO clinical practice guidelines. Based on the evidence level, the following guidelines were determined: Recommendation, Suggestion, and No Guideline Possible. Results A total of 78 papers were identified within the scope of this section, out of which 29 were included in this part, and were analyzed with 27 previously reviewed studies. A new Suggestion was made for oral glutamine for the prevention of OM in head and neck (H&N) cancer patients receiving radiotherapy with concomitant chemotherapy. The previous Recommendation against the use of parenteral glutamine for the prevention of OM in hematopoietic stem cell transplantation (HSCT) patients was reestablished. A previous Suggestion for zinc to prevent OM in H&N cancer patients treated with radiotherapy or chemoradiotherapy was reversed to No Guideline Possible. No guideline was possible for other interventions. Conclusions Of the vitamins, minerals, and nutritional supplements studied for the management of OM, the evidence supports a Recommendation against parenteral glutamine in HSCT patients and a Suggestion in favor of oral glutamine in H&N cancer patients for the management of OM.

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Preventive effects of amino-acid-rich elemental diet Elental® on chemotherapy-induced oral mucositis in patients with colorectal cancer: a prospective pilot study

Cited by 23 publications

References 21 publications

The effect of an elemental diet on oral mucositis of esophageal cancer patients treated with DCF chemotherapy: a multi-center prospective feasibility study (EPOC study)

The effect of an elemental diet on oral mucositis of esophageal cancer patients treated with DCF chemotherapy: a multi-center prospective feasibility study (EPOC study)

The amino acid-rich elemental diet Elental® preserves lean body mass during chemo- or chemoradiotherapy for esophageal cancer

Systematic review of natural and miscellaneous agents for the management of oral mucositis in cancer patients and clinical practice guidelines—part 1: vitamins, minerals, and nutritional supplements

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