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Results of a randomized controlled phase III trial: efficacy of polyphenol-containing cystus® tea mouthwash solution for the reduction of mucositis in head and neck cancer patients undergoing external beam radiotherapy.
Ebert, N, Kensche, A, Löck, S, Hadiwikarta, WW, Hänsch, A, Dörr, W, Krause, M, Hannig, C, Baumann, M
Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]. 2021;(1):63-73
Abstract
PURPOSE To determine the effect of Cystus® tea (Naturprodukte Dr. Pandalis GmbH & Co. KG) as mouthwash compared to sage tea on oral mucositis in patients undergoing radio(chemo)therapy for head and neck cancer. METHODS In this randomized, prospective phase III study, 60 head and neck cancer patients with primary or postoperative radio(chemo)therapy were included between 04/2012 and 06/2014. They received either sage or Cystus® tea for daily mouthwash under therapy. Mucositis was scored twice a week following the Radiation Therapy Oncology Group and the European Organization for Research and Treatment Cancer (RTOG/EORTC) scoring system. Dental parameters were also recorded. Statistical evaluation of the primary endpoint was performed using t‑test and log rank test. RESULTS Data from 57 patients could be evaluated. Patient characteristics showed no significant difference between the two groups (n = 27 sage; n = 30 Cystus®). A total of 55 patients received the prescribed dose (60-66 Gy postoperative; 70-76.8 Gy primary). Mucositis grade 3 was observed in 23 patients (n = 11 sage; n = 12 Cystus®) and occurred between day 16 and 50 after start of therapy. There was no significant difference between the two groups in latency (p = 0.75) and frequency (p = 0.85) of the occurrence of mucositis grade 3. The self-assessment of the oral mucosa and the tolerability of the tea also showed no significant differences. Occurrence of dental pathologies appeared to increase over time after radiotherapy. CONCLUSION Cystus® and sage tea have a similar effect on the occurrence of radiation-induced mucositis regarding latency and incidence. Cystus® tea mouthwash solution is tolerated well and can be applied in addition to intensive oral care and hygiene along with the application of fluorides.
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Effect of Honey-Lemon Spray Versus Benzydamine Hydrochloride Spray on Radiation-Induced Acute Oral Mucositis in Head and Neck Cancer Patients: A Pilot, Randomized, Double-Blind, Active-Controlled Clinical Trial.
Ameri, A, Poshtmahi, S, Heydarirad, G, Cramer, H, Choopani, R, Hajimehdipoor, H, Azghandi, S, Pasalar, M
Journal of alternative and complementary medicine (New York, N.Y.). 2021;(3):255-262
Abstract
Introduction: Oral mucositis (OM) is the most prevalent side effect in patients with head and neck cancer (HNC). It causes an obvious decrease in quality of life (QoL) in these patients, so different medications have been recommended for OM, however, without optimal response. This randomized trial aimed to assess the effects of a honey-lemon spray compared with benzydamine hydrochloride in prevention of radiation-induced OM in patients with HNC. Materials and Methods: Forty-six patients with HNC received external beam radiotherapy for 5 days per week. Patients were randomized to treatment with either benzydamine hydrochloride spray or honey-lemon spray for 5 weeks and continued for 1 week after the end of treatment. The oral cavity was examined weekly, with a score given to each site based on the degree of mucositis using a 4-point scale, and a mean mucositis score was calculated as the primary outcome. Occurrence of OM, pain, QoL, and adverse effects were defined as secondary outcomes. Patients, therapists, and outcome assessors were blinded to group allocation. Results: No significant group differences occurred in the mucositis score, pain, or QoL. Mucositis occurrence rates were higher in the benzydamine hydrochloride group compared with the honey-lemon group (hazard ratio = 2.1, 95% confidence interval: 1.1 to 4.2). Two patients in the honey-lemon group had mild nausea and burning throat; no adverse effects occurred in the benzydamine hydrochloride group. Conclusions: There were no significant group differences in mucositis severity between patients treated with honey-lemon spray and benzydamine hydrochloride. The potential preventive effects of honey-lemon spray need to be confirmed in further trials. The trial registration number is IRCT20161024030467N1.
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A double-blind phase III trial of immunomodulating nutritional formula during adjuvant chemoradiotherapy in head and neck cancer patients: IMPATOX.
Boisselier, P, Kaminsky, MC, Thézenas, S, Gallocher, O, Lavau-Denes, S, Garcia-Ramirez, M, Alfonsi, M, Cupissol, D, de Forges, H, Janiszewski, C, et al
The American journal of clinical nutrition. 2020;(6):1523-1531
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BACKGROUND In a previous phase II study an immunonutrient supplement was found to reduce severe acute toxicities for head and neck squamous cell cancer (HNSCC) patients treated with concomitant cisplatin and radiotherapy. OBJECTIVES The primary objective of the present study was to evaluate efficacy of the same immunonutrient supplement on severe mucositis. Secondary objectives included tolerance, compliance to oral supplementation, chemotherapy interruptions and delays, quality of life, and progression-free survival (PFS) and overall survival (OS) at 1, 2, and 3 y. METHODS Between November 2009 and June 2013, 180 HNSCC patients eligible for adjuvant chemotherapy after surgery with curative intent were included in our double-blind phase III multicenter trial. They were assigned to receive oral supplementation (3 sachets/d) of either a formula enriched with l-arginine and omega-3 (n-3) fatty and ribonucleic acids (experimental arm), or an isocaloric isonitrogenous control (control arm), for 5 d before each of 3 cycles of cisplatin. Intention-to-treat (ITT) and per-protocol (PP) analyses were undertaken, along with subgroup analyses of ≥75% compliant patients, to compare the incidence of acute mucositis (Radiation Therapy Oncology Group and WHO scales) and 36-mo survival. RESULTS At 1 mo after terminating chemoradiotherapy (CRT), no differences were observed in the incidence of grade 3-4 mucositis between treatment groups, in the ITT, PP (172 patients), and subgroup (≥75% compliance, n = 112) analyses. The immunomodulating supplement did not significantly improve survival in the ITT and PP analyses at 3 y after CRT. Among ≥75% compliant patients, however, OS at 3 y was significantly improved in the immunomodulating formula group (81%; 95% CI: 67%, 89%) compared with controls (61%; 95% CI: 46%, 73%; P = 0.034), as well as PFS (73%; 95% CI: 58%, 83% compared with 50%; 95% CI: 36%, 63%; P = 0.012). CONCLUSIONS Although this immunomodulating formula failed to reduce severe mucositis during CRT, the findings suggest that the long-term survival of compliant HNSCC patients was improved.This trial was registered at clinicaltrials.gov as NCT01149642.
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Rationale and design of a randomised controlled trial investigating the effect of multidisciplinary nutritional rehabilitation for patients treated for head and neck cancer (the NUTRI-HAB trial).
Kristensen, MB, Wessel, I, Beck, AM, Dieperink, KB, Mikkelsen, TB, Møller, JK, Zwisler, AD
Nutrition journal. 2020;(1):21
Abstract
BACKGROUND Eating problems frequently affect quality of life and physical, psychological and social function in patients treated for head and neck cancer (HNC). Residential rehabilitation programmes may ameliorate these adverse effects but are not indicated for all individuals. Systematic assessment of rehabilitation needs may optimise the use of resources while ensuring referral to rehabilitation for those in need. Yet, evidence lacks on which nutrition screening and assessment tools to use. The trial objectives are: 1) To test the effect of a multidisciplinary residential nutritional rehabilitation programme compared to standard care on the primary outcome body weight and secondary outcomes health-related quality of life, physical function and symptoms of anxiety and depression in patients curatively treated for HNC and 2) To test for correlations between participants' development in outcome scores during their participation in the programme and their baseline scores in Nutritional Risk Screening 2002 (NRS 2002), the Scored Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF), and M. D. Anderson Dysphagia Inventory (MDADI) and to assess sensitivity, specificity and predictive values of the three tools in relation to a clinically relevant improvement in outcome scores. METHODS In a randomised controlled trial, 72 patients treated for HNC recruited through a nationwide survey will be randomised to a multidisciplinary residential nutritional rehabilitation programme or to a wait-list control group. Data are collected at baseline, three and six months. Primary outcome is change in body weight, and secondary outcomes include changes in quality of life, physical function and symptoms of anxiety and depression. Potential correlations between intervention effect and baseline scores in NRS 2002, PG-SGA-SF and MDADI will be tested, and sensitivity, specificity and predictive values of the three tools in relation to a clinically relevant improvement in outcome scores will be assessed. DISCUSSION This is the first randomised controlled trial to test the effect of a multidisciplinary residential nutritional rehabilitation programme in patients treated for HNC. Recruitment through a nationwide survey gives a unique possibility to describe the trial population and to identify potential selection bias. As the trial will explore the potential of different nutrition screening and assessment tools in the assessment of rehabilitation needs in patients treated for HNC, the trial will create knowledge about how selection and prioritisation of nutritional rehabilitation aimed at patients treated for HNC should be offered. The results may contribute to a better organisation and use of existing resources in benefit of patients treated for HNC. TRIAL REGISTRATION The trial is registered by The Danish Data Protection Agency (registration 2012-58-0018, approval number 18/14847) and the Regional Committees on Health Research Ethics for Southern Denmark (journal number 20182000-165). ClinicalTrials.gov Identifier: NCT03909256. Registered April 9, 2019.
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A randomized phase 2 study of temsirolimus and cetuximab versus temsirolimus alone in recurrent/metastatic, cetuximab-resistant head and neck cancer: The MAESTRO study.
Seiwert, TY, Kochanny, S, Wood, K, Worden, FP, Adkins, D, Wade, JL, Sleckman, BG, Anderson, D, Brisson, RJ, Karrison, T, et al
Cancer. 2020;(14):3237-3243
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BACKGROUND Patients with cetuximab-resistant, recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) have poor outcomes. This study hypothesized that dual blockade of mammalian target of rapamycin and epidermal growth factor receptor (EGFR) would overcome cetuximab resistance on the basis of the role of phosphoinositide 3-kinase signaling in preclinical models of EGFR resistance. METHODS In this multicenter, randomized clinical study, patients with recurrent/metastatic HNSCC with documented progression on cetuximab (in any line in the recurrent/metastatic setting) received 25 mg of temsirolimus weekly plus cetuximab at 400/250 mg/m2 weekly (TC) or single-agent temsirolimus (T). The primary outcome was progression-free survival (PFS) in the TC arm versus the T arm. Response rates, overall survival, and toxicity were secondary outcomes. RESULTS Eighty patients were randomized to therapy with TC or T alone. There was no difference for the primary outcome of median PFS (TC arm, 3.5 months; T arm, 3.5 months). The response rate was 12.5% in the TC arm (5 responses, including 1 complete response [2.5%]) and 2.5% in the T arm (1 partial response; P = .10). Responses were clinically meaningful in the TC arm (range, 3.6-9.1 months) but not in the T-alone arm (1.9 months). Fatigue, electrolyte abnormalities, and leukopenia were the most common grade 3 or higher adverse events and occurred in less than 20% of patients in both arms. CONCLUSIONS The study did not meet its primary endpoint of improvement in PFS. However, TC induced responses in cetuximab-refractory patients with good tolerability. The post hoc observation of activity in patients with acquired resistance (after prior benefit from cetuximab monotherapy) may warrant further investigation.
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A randomized phase III trial for alleviating radiation-induced xerostomia with chewing gum.
Kaae, JK, Stenfeldt, L, Hyrup, B, Brink, C, Eriksen, JG
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. 2020;:72-78
Abstract
BACKGROUND AND PURPOSE Xerostomia is frequently reported after radiotherapy (RT) for head and neck cancer (HNC). The aim of this study was to reduce symptoms of radiation-induced xerostomia in HNC survivors, in which the experimental arm used chewing gum for a month. Primary endpoint was changes in scoring of dry mouth as defined by EORTC QLQ-H&N35 between arms. MATERIALS AND METHODS Participants with any grade of physician-assessed xerostomia, ≥ six month after RT, disease-free and able to chew gum were, for a month, randomized (2:1) to: (Arm A) daily chewing gum or (Arm B) standard care. Xerostomia-related QOL was assessed using EORTC QLQ-H&N35 and GRIX questionnaires along with measurement of salivary flow and viscosity at inclusion and after one month. The study was registered on ClinicalTrials.gov (NCT03302676). RESULTS Ninety-one participants were eligible for analysis (Arm A, n = 55; Arm B, n = 36). Comparing categorized scores for symptoms between arms, reduction of dry mouth was significantly higher for Arm A than Arm B (p = 0.05). A reduction in dry mouth scores was observed for xerostomia assessed by EORTC QLQ-H&N35 (question 41) for both arms. Salivary flow increased and viscosity decreased upon five minutes of stimulation within both arms (p < 0.001, respectively), however no significantly difference was observed between arms. CONCLUSION Categorized scores found reduction of dry mouth to be significantly higher in Arm A than Arm B, but no difference was seen for salivary flow rate and viscosity.
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Efficacy of the plantago major L. syrup on radiation induced oral mucositis in head and neck cancer patients: A randomized, double blind, placebo-controlled clinical trial.
Soltani, GM, Hemati, S, Sarvizadeh, M, Kamalinejad, M, Tafazoli, V, Latifi, SA
Complementary therapies in medicine. 2020;:102397
Abstract
INTRODUCTION Oral mucositis is a complication of radiation therapy in cancer patients. We designed a trial to evaluate efficacy of plantago major on symptoms of radiation induced mucositis in cancer patients. METHODS In this randomized double blind, placebo-controlled trial 23 patients received plantago major syrup as intervention group and 23 patients received placebo syrup as control group for 7 weeks. Outcome measures were severity of mucositis according to WHO scale and severity of patients' pain assessed by visual analogue scale. RESULTS Severity of mucositis were significantly lower in intervention group compared to placebo group (p value<0.05). Also patients in intervention group experienced significantly less pain compared to placebo group during radiotherapy period (p value<0.05) CONCLUSION Plantago major L syrup was effective on the reduction of the symptoms of radiation induced mucositis in patients with head and neck cancers.
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Effects of a Multidisciplinary Residential Nutritional Rehabilitation Program in Head and Neck Cancer Survivors-Results from the NUTRI-HAB Randomized Controlled Trial.
Kristensen, MB, Wessel, I, Beck, AM, Dieperink, KB, Mikkelsen, TB, Møller, JK, Zwisler, AD
Nutrients. 2020;(7)
Abstract
Head and neck cancer survivors frequently experience nutritional challenges, and proper rehabilitation should be offered. The trial objective was to test the effect of a multidisciplinary residential nutritional rehabilitation programme addressing physical, psychological, and social aspects of eating problems after treatment. In a randomized controlled trial, 71 head and neck cancer survivors recruited through a nationwide survey were randomized to the program or a wait-list control group. Inclusion was based on self-reported interest in participation. The primary outcome was change in body weight. Secondary outcomes included physical function, quality of life, and symptoms of anxiety and depression. Differences between groups at the 3-month follow-up were tested. No significant differences were seen in body weight change, but there were overall trends towards greater improvements in physical function (hand grip strength: p = 0.042; maximal mouth opening: p = 0.072) and quality of life ("Role functioning": p = 0.041; "Speech problems": p = 0.040; "Pain": p = 0.048) in the intervention group. To conclude, a multidisciplinary residential nutritional rehabilitation program had no effect on body weight in head and neck cancer survivors with self-reported interest in participation, but it may have effect on physical function and quality of life. Further research on relevant outcomes, inclusion criteria, and the program's effect in different subgroups is needed.
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Oral administration of nanomicelle curcumin in the prevention of radiotherapy-induced mucositis in head and neck cancers.
Delavarian, Z, Pakfetrat, A, Ghazi, A, Jaafari, MR, Homaei Shandiz, F, Dalirsani, Z, Mohammadpour, AH, Rahimi, HR
Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry. 2019;(2):166-172
Abstract
UNLABELLED Oral mucositis (OM) is a complication of head and neck cancer (HNC) therapy with negative impact on the quality of life. Although definitive treatment has not yet been established, there is interest towards the use of natural compounds owing to their few side effects. Curcumin has a variety of biological and pharmacological properties including anticancer and anti-inflammatory effects. AIM: The aim of this study is to evaluate the effect of curcumin in the form of nanomicelle on OM in HNC patients receiving radiotherapy. METHODS In this clinical trial, 32 HNC patients were allocated to case and control groups, and respectively received nanocurcumin or placebo during radiotherapy. RESULTS We found a statistically significant difference in the severity of mucositis between the 2 groups at all visits. In contrast to the control-group patients, who all developed OM in the 2nd week of radiotherapy, only 32% of the case group developed OM with no obvious oral or systemic side effects. CONCLUSION Our data show that nanomicelle curcumin is an effective agent in the prevention of OM or reducing its severity. Thus, the administration of nanocurcumin can be considered as a reasonable approach to hinder the development of OM in HNC patients requiring radiotherapy.
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Effects of Tualang Honey on Cancer Related Fatigue: A Multicenter Open-label Trial of H&N Cancer Patients.
Ramasamy, V, Binti Mat Lazim, N, Abdullah, B, Singh, A
The Gulf journal of oncology. 2019;(30):43-51
Abstract
INTRODUCTION Cancer related fatigue (CRF) is a problem experienced by head and neck cancer patients, especially those who undergo chemoradiation therapy. CRF may persist for years post chemoradiation therapy and significantly impair their quality of life (QOL). Tualang honey is rich in amino acids, vitamins, minerals and enzymes. It is proven to have anti-inflammatory, antioxidant and anti-tumour properties. As CRF is related to inflammatory mediators, the effects of Tualang Honey may improve CRF. The aim of this study is to determine if Tualang honey has a role in improving CRF and quality of life among head and neck cancer patients post chemoradiation. METHODOLOGY In this open labelled randomized clinical trial, 40 participants aged between 18 and 65 with head and neck cancer who completed chemotherapy and/or radiotherapy in Hospital USM, Kelantan Malaysia or Hospital Taiping were recruited and randomized into two groups: Tualang honey (experimental) group or Vitamin C (control) group. They were prescribed with either daily oral Tualang honey 20mg or vitamin C tablet 100 mg for 8 weeks. Level of fatigue and quality of life were measured using FACIT-Fatigue and FACT H&N questionnaires at baseline, 4 weeks and 8 weeks. The white cell count and C-reactive protein level were also measured at baseline, 4 weeks and 8 weeks. RESULTS After four and eight weeks of treatment with Tualang honey or Vitamin C, the fatigue level for experimental group was better than in the control group, and the differences were statistically significant (p<0.05). Statistically significant improvements were seen on quality of life (p<0.05) for the experimental group at week 8, however, no significant improvements were seen in white cell count and C-reactive protein level between control and experimental group. CONCLUSION Our research provided support for the use of Tualang honey to improve CRF and QOL in head and neck cancer patients post chemotherapy or radiotherapy.