Nutritional evaluation and dietetic care in cancer patients treated with radiotherapy: prospective study. [Dietary information after radiotherapy of head and neck cancer]. Feasibility of non-cisplatin-based induction chemotherapy and concurrent chemoradiotherapy in advanced head and neck cancer. Randomized study of percutaneous endoscopic gastrostomy versus nasogastric tubes for enteral feeding in head and neck cancer patients treated with (chemo)radiation. [Results of a prospective randomized trial with induction chemotherapy for cancer of the oral cavity and tonsils]. First-year quality of life assessment of an intra-arterial (RADPLAT) versus intravenous chemoradiation phase III trial. Impact of nutrition on outcome: a prospective randomized controlled trial in patients with head and neck cancer undergoing radiotherapy. Randomized study of adjuvant chemotherapy for head and neck cancer. Prostaglandin inhibitor and radiotherapy in advanced head and neck cancers.
Ninety-three cancer patients about to undergo radiotherapy were studied. These patients were affected by cancer of the head and neck, breast cancer, and abdominopelvic cancer. They were randomly distributed into control and experimental groups. The patients from the control group were allowed to eat ad libitum, whereas those from the experimental group followed a strict nutritional protocol that covered their needs while satisfying their particular tastes and habits. Data were collected the day before radiotherapy commenced and the day treatment ended. Anthropometric, analytical, and clinical parameters were determined. The results showed the benefit of dietetic treatment in experimental patients with head and neck or abdominopelvic cancer. After completed radiotherapy, 24 in-patients and 25 out-patients enrolled at the Department of Otolaryngology, National Hospital, were randomised to either tailored dietary information and instruction by a clinical nutritionist or regular dietary information from a nurse. At the six weeks follow-up examination the incidence of malnutrition, as evaluated by anthropometry and routine blood analyses, was lower among the patients who had been given intensive information than those who had received regular information (p < 0.05). Out-patients lost more weight than in-patients did (p < 0.05). The in-patients randomised to intensive dietary information were the only ones who did not lose weight. This study indicates a beneficial effect of intensive dietary advice in order to improve nutritional status after radiation treatment. The purpose of the present study was to determine the safety and efficacy of induction chemotherapy followed by concomitant chemoradiotherapy. Thirty-eight patients were randomised to receive induction chemotherapy, consisting of cyclophosphamide and methotrexate followed by concomitant 5-fluorouracil and irradiation (study group) or irradiation alone (control group). There were non-significant differences in the initial tumor clearance rates in the two groups. Median disease-free survival (in complete responders) was 17 months (6-60+) vs 11 months (5-60+) (p = 0.407) and overall survival 11 months (1-60+) vs 14 months (2-60+) (p = 0.428) in the study and control groups respectively. Acute morbidity and deaths during intervention were higher in the study group (p = 0.007). This study suggests that induction along with concomitant chemoradiotherapy is too toxic for routine use and also fails to provide a survival benefit. Percutaneous endoscopic gastrostomy (PEG) tubes have largely replaced nasogastric tubes (NGT) for nutritional support of patients with head and neck cancer undergoing curative (chemo)radiotherapy without any good scientific basis. A randomized trial was conducted to compare PEG tubes and NGT in terms of nutritional outcomes, complications, patient satisfaction and cost. The study was closed early because of poor accrual, predominantly due to patients' reluctance to be randomized. There were 33 patients eligible for analysis. Nutritional support with both tubes was good. There were no significant differences in overall complication rates, chest infection rates or in patients' assessment of their overall quality of life. The cost of a PEG tube was 10 times that of an NGT. The duration of use of PEG tubes was significantly longer, a median 139 days compared with a median 66 days for NGT. We found no evidence to support the routine use of PEG tubes over NGT in this patient group. Although induction chemotherapy administered prior to local therapy produces encouraging initial response rates in head and neck cancer, randomized studies have failed to demonstrate an improvement in survival rates. All randomized studies included only patients with advanced stage III and IV disease. In our opinion, this is the main reason for the low rate of complete responses demonstrated in the randomized trials (maximum 18%). Frei et al. estimate that a 40%-50% complete response rate is necessary before improved survival rates are seen. To date, such complete response rates with induction chemotherapy have only been attainable in resectable T2-T3, N0-N2 disease. Therefore, we initiated a prospective randomized trial including only patients with the mentioned disease stages. Patients (pts) were randomized to receive either induction chemotherapy with three cycles of carboplatin/5-FU prior to surgery and radiotherapy (arm A, 70 pts) or standard treatment with surgery and radiotherapy (arm B, 74 pts). Patients were classified according to primary tumour site and neck disease. The observed remission rate after chemotherapy confirmed the primary estimated rate for this subgroup of patients with head and neck cancer (CR: 43%, PR: 37%, NR: 15%, PD: 5%). After a follow-up of 12-96 months overall survival was 58% in arm A and 45% in arm B (n.s.). Disease-free survival in arm A (61%) is statistically significantly better than in arm B (43%, P=0. 03). Therefore, we recommend further controlled trials to investigate the role of induction chemotherapy in patients with primary resectable carcinomas of the oral cavity and tonsils and stage T2-T3 and N0-N2 disease prior to surgery. We report the results of a multicenter randomized phase III study, assessing quality of life (QOL) in intra-arterial (IA) versus standard intravenous (IV) chemoradiation in advanced head and neck cancer.
                Two hundred seven patients with inoperable stage IV disease-152 men and 55 women; mean age, 55 years-were included in this study. The patients were treated with standard radiotherapy with 4 weekly IA or 3 weekly IV cisplatin infusions. The QOL assessments carried out were EORTC-C30, H&N35, and trial-specific questionnaires.
                Overall QOL deteriorated in all patients during treatment, is gradually improving over 1 year. IA patients showed significantly less nausea and vomiting at week 7 (p <.001). IV patients were significantly more fatigued (p <.006). At 1 year, no significant difference in tube feeding was found. Voice quality slightly exceeded the pretreatment values at 1 year. Forty-two of 62 employed patients returned to work.
                During treatment, significantly fewer problems with nausea and vomiting occurred in IA than in IV patients. Both groups showed improved voicing and oral intake during follow-up, often exceeding pretreatment values at 1 year.
                (c) 2008 Wiley Periodicals, Inc. Head Neck, 2009. We aimed to determine the effect of dietary counseling or oral supplements on outcome for patients with cancer, specifically, nutritional outcome, morbidity, and quality of life (QOL), during and 3 months after radiotherapy.
                Seventy-five patients with head and neck cancer who were referred for radiotherapy (RT) were randomized to the following groups: group 1 (n = 25), patients who received dietary counseling with regular foods; group 2 (n = 25), patients who maintained usual diet plus supplements; and group 3 (n = 25), patients who maintained intake ad lib. Nutritional intake (determined by diet history) and status (determined by Ottery's Subjective Global Assessment), and QOL (determined by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 [EORTC QLQ-C30]) were evaluated at baseline, at the end of RT, and at 3 months.
                Energy intake after RT increased in both groups 1 and 2 (p < or = .05). Protein intake also increased in both groups 1 and 2 (p < or = .006). Both energy and protein intake decreased significantly in group 3 (p < .01). At 3 months, group 1 maintained intakes, whereas groups 2 and 3 returned to or below baseline levels. After RT, >90% of patients experienced RT toxicity; this was not significantly different between groups, with a trend for reduced symptomatology in group 1 versus group 2/group 3 (p < .07). At 3 months, the reduction of incidence/severity of grade 1+2 anorexia, nausea/vomiting, xerostomia, and dysgeusia was different: 90% of the patients improved in group 1 versus 67% in group 2 versus 51% in group 3 (p < .0001). After RT, QOL function scores improved (p < .003) proportionally with improved nutritional intake and status in group 1/group 2 (p < .05) and worsened in group 3 (p < .05); at 3 months, patients in group 1 maintained or improved overall QOL, whereas patients in groups 2 and 3 maintained or worsened overall QOL.
                During RT, nutritional interventions positively influenced outcomes, and counseling was of similar/higher benefit; in the medium term, only counseling exerted a significant impact on patient outcomes.
                Copyright 2005 Wiley Periodicals, Inc. The ability of surgery and radiotherapy to control advanced squamous cell carcinoma of the head and neck has reached its maximal potential. We initiated a randomized, prospective, stratified study of adjuvant chemotherapy. Patients with stage II disease of the pyriform sinus and stage II and IV disease of the oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, and paranasal sinuses were eligible. Patients were randomized to receive either standard therapy alone or two courses of 5-fluorouracil (B-CMF) chemotherapy prior to and two courses after the completion of standard therapy. Standard therapy consisted of preoperative irradiation followed by radical surgery. Of 133 patients with advanced disease, 83 were included in the study--43 in the chemotherapy group and 40 in the control group. Rates of residual and recurrent disease, as well as distant metastases, were similar for the two groups. The survival rates of patients without persistent disease at the end of treatment showed no significant difference for the two groups. The study has been discontinued because statistical analysis indicated that the addition of more patients would not materially increase the statistical significance of the study. Radiotherapy is the usual mode of treatment for unresectable head and neck cancer. To improve cure rates, extend survival, and reduce morbidity, we use accelerated hyperfractionation radiotherapy and an adjuvant drug to inhibit prostaglandin synthesis. In this study, 19 patients received 300 rad/day of radiotherapy in two equally divided doses to a total dose averaging 6,200 rad. Either indomethacin, 25 mg, or placebo was given four times a day in a double-blind fashion during therapy. Radiation mucositis was graded as 0 to 4+; pain, nutritional status, and tumor status were monitored daily and recorded biweekly. Evaluation of the data showed delayed mucositis in the experimental group for grades 1 to 3, with a significant difference at grade 3 compared with controls. The significance of a long-term comparison of cure rates would be doubtful considering the heterogeneity of the primary sites and regional disease in this group coupled with the small size of our study.
There is not sufficient evidence to determine the optimal method of enteral feeding for patients with head and neck cancer receiving radiotherapy and/or chemoradiotherapy. Further trials of the two methods of enteral feeding, incorporating larger sample sizes, are required.