Exploratory study of clinical effectiveness and safety of TJ-116 bukuryoingohangekobokuto for anxiety and postoperative water brash in esophageal cancer patients (TJ116E).

BACKGROUND: Patients with esophageal cancer suffer from anxiety in the perioperative period surrounding esophagectomy; this may increase the risk of postoperative complications. In particular, postoperative aspiration pneumonia carries a high risk of hospital mortality. Bukuryoingohangekobokuto (BRIHK) is a traditional Japanese medicine formula used to treat anxiety, the feeling of a foreign body in the esophagus, and water brash. We hypothesize that BRIHK might be effective for both anxiety and water brash in perioperative patients with esophageal cancer. The aim of this study is to evaluate the efficacy and safety of BRIHK compared to a placebo for anxiety and water brash in perioperative esophageal cancer patients. METHOD/DESIGN: This will be a single-center, single blind, placebo-controlled randomized clinical trial. Twenty-four patients with esophageal cancer undergoing radical resection surgery will be registered to participate, then randomly and blindly assigned to the BRIHK treatment group or control group. Patients will be administered BRIHK or the placebo from 2 weeks before to 6 weeks after surgery. Primary outcome measures will be anxiety and depression (assessed using the Hospital Anxiety and Depression Scale), and water brash (assessed using the 10-item Eating Assessment Tool, Esophagus and Stomach Surgery Symptom Scale, and videofluoroscopy swallowing measurement). Incidences of aspiration pneumonia will be noted and abdominal gas volume, inflammatory markers, and nutrition status will be evaluated. DISCUSSION: This investigative study will provide clinical evidence of BRIHK administration for anxiety and water brash, which might improve mental distress and reduce postoperative mortality. TRIAL REGISTRATION: The protocol and progress are registered on the Japan Registry of Clinical Trials (jRCT s021190001) and University Hospital Medical Information Network (UMIN000031330). The protocol was approved by the Japanese Ministry of Health, Labour and Welfare certified clinical research review board, Tohoku University (CRB2180001).

Health-related quality of life in a randomized trial of neoadjuvant chemotherapy or chemoradiotherapy plus surgery in patients with oesophageal cancer (NeoRes trial).

BACKGROUND: There are few data comparing health-related quality of life (HRQoL) after neoadjuvant chemotherapy alone (nCT) compared with neoadjuvant chemoradiotherapy (nCRT) in patients with oesophageal cancer. METHODS: In the NeoRes trial, patients were assigned randomly in a 1 : 1 ratio to receive either cisplatin 100 mg/m2 on day 1 and an infusion of 750 mg per m2 5-fluorouracil over 24 h on days 1-5 in three 21-day cycles (nCT) or the same chemotherapy regimen, but with the addition of 40 Gy radiotherapy (nCRT). HRQoL data were collected at baseline, after neoadjuvant therapy and at 1, 3 and 5 years after surgery. The European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 and disease-specific modules were used. RESULTS: Of 181 patients randomized, 165 were included in the analysis of HRQoL. In a direct comparison between the allocated treatments, odynophagia after completion of neoadjuvant therapy but before surgery (P = 0·047) and troublesome coughing at 3 years' follow-up (P = 0·011) were more pronounced in the nCRT arm. In the longitudinal analyses within each treatment arm, a large deterioration in HRQoL was noted at 1 year. Some recovery was seen in both arms over time but, after 3 and 5 years, patients in the nCRT arm reported more symptoms compared with baseline than patients in the nCT arm. CONCLUSION: HRQoL after multimodal treatment for cancer of the oesophagus or gastro-oesophageal junction was impaired and more pronounced in patients who underwent nCRT, with only partial recovery over time.

ANTECEDENTES: Se dispone de poca información sobre la calidad de vida relacionada con la salud (health-related quality of life, HRQOL) en pacientes con cáncer de esófago después de quimioterapia neoadyuvante sola en comparación con quimiorradioterapia neoadyuvante. MÉTODOS: En el ensayo NeoRes, los pacientes fueron asignados de forma aleatoria 1:1 a tratamiento con cisplatino 100 mg/m2 en el día uno y 5-Fluorouracilo 750 mg/m2 /infusión de 24 horas en los días 1-5 en tres ciclos de 21 días (nCT) o al mismo régimen de quimioterapia, pero con la adición de radioterapia 40 Gy (nCRT). Los datos de HRQOL se recogieron al inicio, tras el tratamiento neoadyuvante y al cabo de 1, 3 y 5 años tras la cirugía. Se utilizaron los cuestionarios QLQ-C30 de la European Organisation for Research and Treatment of Cancer (EORTC) y los módulos específicos para la enfermedad. RESULTADOS: De 181 pacientes aleatorizados, 165 fueron incluidos en el análisis de la HRQOL. En la comparación directa entre los tratamientos asignados, la odinofagia tras terminar nCRT pero antes de la cirugía (P = 0,047) y la tos molesta a los 3 años de seguimiento (P = 0,011), fueron más acentuadas en el brazo de nCRT. En el análisis longitudinal dentro de cada rama de tratamiento hubo un fuerte deterioro en la HRQOL al año. Se observó cierta recuperación en ambas ramas con el tiempo, pero a los 3 y 5 años de seguimiento, los pacientes de la rama de nCRT describieron más síntomas en comparación con la situación de inicio que los pacientes de la rama de nCT. CONCLUSIÓN: La HRQOL después del tratamiento multimodal del cáncer de esófago o de la unión gastroesofágica se ve afectada, siendo dicha afectación más pronunciada en pacientes que recibieron nCRT, recuperándose solo parcialmente con el tiempo.

Dyadic yoga program for patients undergoing thoracic radiotherapy and their family caregivers: Results of a pilot randomized controlled trial.

OBJECTIVE: Thoracic radiotherapy (TRT) may result in toxicities that are associated with performance declines and poor quality of life (QOL) for patients and their family caregivers. The purpose of this randomized controlled trial was to establish feasibility and preliminary efficacy of a dyadic yoga (DY) intervention as a supportive care strategy. METHODS: Patients with stage I to III non-small cell lung or esophageal cancer undergoing TRT and their caregivers (N = 26 dyads) were randomized to a 15-session DY or a waitlist control (WLC) group. Prior to TRT and randomization, both groups completed measures of QOL (SF-36) and depressive symptoms (CES-D). Patients also completed the 6-minute walk test (6MWT). Dyads were reassessed on the last day of TRT and 3 months later. RESULTS: A priori feasibility criteria were met regarding consent (68%), adherence (80%), and retention (81%) rates. Controlling for relevant covariates, multilevel modeling analyses revealed significant clinical improvements for patients in the DY group compared with the WLC group for the 6MWT (means: DY = 473 m vs WLC = 397 m, d = 1.19) and SF-36 physical function (means: DY = 38.77 vs WLC = 30.88; d = .66) and social function (means: DY = 45.24 vs WLC = 39.09; d = .44) across the follow-up period. Caregivers in the DY group reported marginally clinically significant improvements in SF-36 vitality (means: DY = 53.05 vs WLC = 48.84; d = .39) and role performance (means: DY = 52.78 vs WLC = 48.59; d = .51) relative to those in the WLC group. CONCLUSIONS: This novel supportive care program appears to be feasible and beneficial for patients undergoing TRT and their caregivers. A larger efficacy trial with a more stringent control group is warranted.

[Esophageal cancer: common health problems and health management].

Esophageal cancer is the 9th leading cause of cancer death in Taiwan. Lack of obvious symptoms or signs during its early stages means that patients are often already in the terminal stage or metastasis at their first diagnosis. A diagnosis of cancer greatly impacts both patients and their families. The purpose of this paper is to explore the current diagnostic methods and treatments used for esophageal cancer. We discuss the effects of physical, psychological and social problems such as dysphagia, fatigue, pain, uncertainty, and social isolation. We also explore the nursing interventions related to these problems. Understanding the health issues related to esophageal cancer will not only help nurses who take care of patients with esophageal cancer provide holistic care, it will also reduce patients' suffering through the treatment and recovery process. By applying interventions that effectively address the physical, psychological, and social realms, healthcare professionals can help patients feel more secure when dealing with related problems. This will improve patients' dignity, value and quality of life through their cancer journey.

The role of identity in adjustment among survivors of oesophageal cancer.

The study sought to contextualize the physical, social and emotional adjustments that are faced by oesophageal cancer patients following surgery. Semi-structured interviews were conducted with five survivors, guided by the principles of Interpretative Phenomenological Analysis (IPA). Participants' accounts encompassed descriptions of personal, social and medical relationships, illness and treatment experiences, eating behaviours, and spiritual and religious perspectives, representing myriad challenges to the self-concept. Surviving patients may have a role in addressing patient expectations about eating. The importance of attempts to nurture and maintain a sense of self should be recognized by those providing care.

Health-related quality of life in long-term survivors after high-dose chemoradiotherapy followed by surgery in esophageal cancer.

Curative treatment of esophageal cancer with definitive or preoperative high-dose chemoradiotherapy inflicts a major strain on the patients with potentially severe physical, emotional, and social consequences. The aim of this study was to assess various aspects of quality of life and fatigue in long-term survivors following such a treatment. Patients undergoing a potentially curative treatment between 1996 and 2007, and still alive (n= 41) completed quality of life questionnaires of the European Organization for Research and Treatment of Cancer core questionnaire (QLQ-C30) and esophageal cancer module (QLQ-OES18). Twenty patients were treated by surgery alone, and 21 patients were scheduled for high-dose chemoradiotherapy followed by surgery. Five of those patients did not undergo planned surgery. Preoperative chemoradiotherapy consisted of three courses of chemotherapy, cisplatin 100 mg/m(2) and 5-fluorouracil 5000 mg/m(2) in each course and concomitant radiotherapy of a median dose 66 Gy. Quality of life in esophageal cancer patients receiving high-dose chemoradiotherapy was compared with that for esophageal cancer patients who received only surgery, head and neck cancer patients, laryngectomized patients, and a random sample of the general Norwegian population. Esophageal cancer patients treated by high-dose chemoradiotherapy had significantly worse global quality of life as reflected by almost all functional scales and higher fatigue compared with esophageal cancer patients who received surgery alone, head and neck cancer patients, and the general Norwegian population. There were no significant differences in quality of life between the esophageal cancer patients receiving high-dose chemoradiotherapy and the laryngectomy patients. Further, the esophageal cancer patients receiving high-dose chemoradiotherapy had higher intensity of other symptoms like general pain, insomnia, nausea/vomiting, diarrhea, and constipation compared with the esophageal cancer patients who received surgery alone, head and neck cancer patients, and the general Norwegian population. High-dose chemoradiotherapy with cisplatin and 5-fluorouracil had a considerable negative long-term effect on global quality of life in patients with resectable esophageal cancer. Fatigue was a prominent long-lasting symptom in these patients.

Marital status and quality of life in patients with esophageal cancer or Barrett's esophagus: the mayo clinic esophageal adenocarcinoma and Barrett's esophagus registry study.

BACKGROUND: Patients with esophageal carcinoma (EC) report deficits in quality of life (QOL), depending on the extent of malignant disease and the goals of treatment at the time of QOL measurement. AIMS: To quantify the association of marital status and changes in QOL over time in patients with EC and patients with Barrett's esophagus (BE). METHODS: Eligible patients in the Mayo Clinic Esophageal Adenocarcinoma and Barrett's Esophagus Registry completed QOL assessments at baseline and approximately 1 year later. QOL was determined with a ten-point linear analog self-assessment scale evaluating overall QOL and 12 subscales. RESULTS: Overall, 489 BE patients and 212 EC patients were evaluated. Married EC patients reported higher baseline QOL in legal concerns (8.1 vs. 7.1; p = .04) and friend and family support (9.3 vs. 8.4; p = .02) than single EC patients. Over time, married EC patients had a decrease in pain frequency QOL compared to single EC patients (-0.9 vs. +0.6; p = .02), with other QOL measures being stable. Married BE patients showed higher social activity QOL at baseline than single BE patients (7.5 vs. 6.9; p = .02); QOL was stable over time between the marital status groups. CONCLUSIONS: Minor, but statistically significant, changes were reported regarding QOL in two categories at baseline and over time among married and single patients with EC. Minor differences may be present between married and single EC patients regarding spiritual QOL at baseline and in overall physical well-being QOL at baseline and over time, although these differences did not reach statistical significance.

A retrospective comparison of clinical outcomes and quality of life measures between definitive chemoradiation alone and radical surgery for clinical stage II-III esophageal carcinoma.

BACKGROUND: This retrospective study was conducted to compare the treatment and quality of life (QOL) results between radical surgery and definitive chemoradiotherapy (CRT) for stage II-III carcinoma of the esophagus. METHODS: Between 2000 and 2009, 128 consecutive patients were selected for this study in which 72 were treated with definitive CRT and 56 with radical surgery. QOL was assessed using Functional Assessment of Cancer Therapy-Esophagus for 51 patients who were free of disease at the time of survey. RESULTS: With a median follow-up period of 37.8 months with 66 survivors, the 4y-DFS in the surgery group were 36% in the CRT group and 51% in the surgery group (P = 0.0028). In the CRT group, the number of cases of the advanced age, T4 stage, and stage III was significantly larger than the surgery group. QOL assessments were completed at rates of 100% in the CRT group and 88% in the surgery group. Overall E Total score had a significant difference between arms (CRT > surgery, P = 0.045). CONCLUSIONS: CRT was inferior to surgery in survival but superior in QOL measures, although the CRT group had a larger number of patients with poorer prognostic factors.

The role of chemoradiotherapy in maintaining quality of life for advanced esophageal cancer.

From May 1996 to July 1996, three male patients with advanced esophageal cancer with complete obstruction were treated with concurrent chemoradiotherapy. The first two courses of chemotherapy using 5-Fluorouracil (500 mg/m2) and Leucovorin (200 mg/m2) on day one through day five were given concurrently with radiotherapy. After completion of radiotherapy, four more courses of chemotherapy using the same regimen were given every four weeks. The total dose of irradiation using six MV linear accelerator given to the primary tumor was 5,000 cGy in 28 fractions. All three patients had relief of their obstruction with complete regression of the tumor after the completion of their treatment. All patients improved clinically and were able to remain symptom-free until the time of their death. The first patient survived for 12 months and died of respiratory failure because of his chronic obstructive pulmonary disease. The second patient also survived 12 months but died of liver metastasis. The third patient lived for 10 months and died of aspiration pneumonia.

Apnea in postsurgical hypnotherapy of an esophageal cancer patient: a brief communication.

Use of clinical hypnosis in the postsurgical psychotherapy of an esophageal cancer patient who could not swallow involved reenactment of the successful surgery and producing hallucinations of taste and smell, as well as working through emotions relations to the surgery and her disease. An apnea that occurred in a late phase of the treatment was addressed with the familiar arm pumping technique that had been used as a deepening technique, resulting in the patient's resuming normal breathing. The experience reminds the practitioner of the possible unexpected professional demands when working in a medical environment. It also provides clues as to the underlying psychological mechanisms and their role in successful symptom removal. A 6-year follow-up confirmed the lasting effect of this brief psychotherapy.