Introducing a standardized assessment of patients' interest in and usage of CAM in routine cancer care: chances and risks from patients' and physicians' point of view.

BACKGROUND: Cancer patients often use complementary and alternative medicine (CAM), however, standardized assessment in clinical routine is missing. The aim of this study was to evaluate a screening questionnaire on CAM usage that was published in the S3 Guideline Complementary Medicine in the Treatment of Oncological Patients. METHODS: We developed a survey questionnaire to assess the practicability of the guideline questionnaire and communication on CAM between health care providers (HCPs) and patients. We collected 258 guideline questionnaires and 116 survey questionnaires from ten clinics and held twelve semi-structured interviews with HCPs. RESULTS: 85% used at least one of the listed CAM methods, 54 participants (N = 77) never disclosed usage to a physician. The most frequently used CAM methods were physical activity (76.4%) and vitamin D (46.4%). 25.2% used at least one method, that was labeled risky by the guideline. 53.4% did not know of CAM's risk of interactions and side effects. Introducing the guideline questionnaire in routine cancer care increased the rate of patients talking to an HCP regarding CAM significantly from 35.5 to 87.3%. The HCPs stated positive effects as an initiation of conversation, increased safety within CAM usage and patients feeling thankful and taken seriously. However, due to the limited amount of time available for discussions on CAM, generalized distribution to all patients was not feasible. CONCLUSION: Institutions should focus on implementing standard procedures and resources that help HCPs discuss CAM on a regular basis. HCPs should meet the patient's demands for CAM counseling and make sure they are equipped professionally.

Patients with advanced cancer and their usage of complementary and alternative medicine.

PURPOSE: A total of 40 % of cancer patients use complementary and alternative medicine (CAM), and patients with advanced cancer use CAM more often than others. The aim of our study was to gather data on CAM use and reasons to use CAM of patients with advanced cancer being admitted for residential palliative care and their relatives. METHODS: Structured interviews were carried out with 25 patients and 25 relatives of those patients, respectively, of a German comprehensive cancer center based on a standardized questionnaire of the working group Prevention and Integrative Oncology of the German Cancer Society. RESULTS: Median age of patients was 64.5 years (relatives: 53.5); 15 patients were male and 10 were female (relatives: 7 and 18). In total, 40 % of all patients used some CAM method at the time of the study, supplements and prayer being the most frequent method. Main reasons for using CAM were to sustain one's own strength (52 % for patients and 72 % for relatives) and to be able to do something by oneself (36 and 40 %). Sources of information were television/radio (48 and 28 %) and family/friends (40 and 48 %). Relatives also use the Internet (40 %). CONCLUSIONS: Also for patients in palliative care and their relatives, CAM is important. Reasons for using CAM are similar for patients with less advanced cancer. As most patients do not discuss using CAM with their physician, side effects and interactions of biologically based treatments may be dangerous. The desire of patients to act autonomously should be encouraged. Yet, physicians should ensure safe administration of complementary methods by including CAM in their communication with the patient and the family.

How are Interactions Taken into Account in Studies on Conventional and Complementary Therapies for Breast Cancer Patients with Menopausal Complaints?

Introduction: Postmenopausal symptoms in breast cancer patients undergoing antihormone treatment lead to high drop-out rates from the therapy. From the therapeutic point of view, methods of both conventional and complementary medicine are concerned. Interactions are being discussed in cases of natural substances. However, they are also relevant for conventional medical substances. The aim of this analysis is to answer the question as to what extent potential interactions are taken into account in clinical studies and reviews on supportive therapies. Materials and Methods: Clinical studies and reviews were identified by means of a systematic search and analysed with regard to the consideration of potential interactions. Results: Altogether 46 clinical studies and one Cochrane review were found. Among the 35 studies on conventional drug therapies, 5 (14 %) took possible interactions into account. Among the 17 studies on complementary medicine, there were 2 (11.7 %) such publications. The Cochrane review did not mention interactions. Discussion: For future studies in which interactions cannot be excluded, a strategy to control for their clinically relevant consequences should be developed. The present authors suggest that the use of survival and recurrence data as secondary endpoints, also for studies on purely supportive therapies, is a reasonable approach. The resulting considerations for study routines are listed thematically.

[Inappropriate and insufficient nutrition in ENT tumors]. / Mangel- und Fehlernährung bei HNO-Tumoren.

Tumours of the upper aerodigestive tract cause malnutrition in the majority of ENT cancer patients. This situation is complicated by multimodal treatment regimens (including surgery and/or irradiation). The resulting malnutrition is a disease entity in its own right and requires special treatment concepts. Effective screening tools (NRS 2002) need to be introduced and data such as body mass index and bioimpedance analysis need to be gathered. The nutrition plan for individual ENT patients differs according to the grade of malnutrition and dysphagia. Oral nutrition should always form the basis of any nutrition programme, such that logopedic therapy is required in all cases of dysphagia. Artifical, oral high-energy nutrition is a pharmacological procedure as well as enteral feeding via PEG or PEJ. Partial or total parenteral nutrition (central venous access) should be restricted to crisis interventions or fast-track regimens.

Limited effects of selenium substitution in the prevention of radiation-associated toxicities. results of a randomized study in head and neck cancer patients.

OBJECTIVE: The substitution of selenium activates the selenium-dependent enzyme glutathione peroxidase, which is important for scavenging free radicals. To date, only limited data are available about the clinical impact of selenium regarding the toxicities due to free radical producing therapies, e.g. irradiation or chemotherapy, and therefore the objective of this study was to investigate the clinical impact of selenium in such therapies. PATIENTS AND METHODS: 39 patients (8 female, 31 male) with advanced head and neck cancer were included in a randomised phase II study. The mean age was 63.52+/-9.31 years. Tumour localizations: oral cavity 15 patients, oropharynx 19 patients, hypopharynx 5 patients, carcinoma of unknown primary 1 patient. Group A (n=22) received 500 microg sodium selenite on the days of radiotherapy and 300 microg sodium selenite on days without radiotherapy. Group B (17) was irradiated without any selenium substitution. Both groups were well balanced according to age, gender, localization and stage of the tumour. The RTOG grade of radiation-associated toxicities was evaluated once per week. RESULTS: The following serious toxicities were observed (group A vs. group B): dysphagia 22.7% vs. 35.3%, loss of taste 22.7% vs. 47.1%, dry mouth 22.7% vs. 23.5%, and stomatitis 36.4% vs. 23.5%. A statistical trend (Fisher's exact test) was only seen for the loss of taste (p=0.172). The weekly patient analysis (Student's t-test) showed a significant reduction of dysphagia in the selenium group (Group 1) at the last week of irradiation. CONCLUSION: This small randomised trial showed limited effects of selenium in the prevention of ageusia (loss of taste) and dysphagia due to radiotherapy of head and neck cancer.

Complementary and alternative medicine in lung cancer patients: a neglected phenomenon?

Study on the use of complementary and alternative medicine (CAM) in lung cancer patients has been widely neglected. Therefore, we initiated a study on the use of CAM in lung cancer patients in addition to radiation treatment. Overall, 120 patients from 3 institutions were interviewed by a standardized questionnaire. Besides the tumor parameters and the use of CAM, the reason for the use, patient information of the medication, the information sources and the subjective condition of the patient. Altogether, 54% of the patients reported using CAM (66% of female patients, 52% of male patients). The most frequently used CAM measures were vitamin combinations (17%), mistletoe (15%), and selenium (12%). A total of 52% reported the wish to support the tumor treatment as a reason for using CAM and 27% had a 'better feeling' using CAM. 50% of CAM was bought by the patients themselves and 50% were prescribed by their family physicians. The use of CAM is frequent in lung cancer patients. Our results suggest that it is very important to obtain information on the CAM use of patients and, particularly in controlled clinical trials, to prospectively document it.

[Plantar fasciitis and radiotherapy. Clinical and radiobiological treatment results]. / Plantare Fasziitis und Strahlentherapie Klinische und strahlenbiologische Ergebnisse der Behandlung.

Patients with plantar fasciitis and pain refractory to conventional therapy are treated with low-dose radiotherapy (RT), but no conclusive evidence-based and radiobiological studies had been performed. In 2001 the German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD) carried out a study by mailing a standardized questionnaire. A total of 136 institutions treated 3621 patients/year with chronic or refractory pain. The median total dose was 6 Gy (median single dose: 1 Gy); 76 institutions reported data of their clinical evaluation of a total of 7947 patients. Pain relief lasting for at least 3 months was reported in 70% and persistent pain relief in 65%. There were no acute or chronic radiogenic side effects observed. The radiobiological studies showed a significant increase of granulocyte function at 1.5 Gy and a significant decrease at 3.5 and 4.0 Gy. These results may provide a possible explanation for a local anti-inflammatory effect of low-dose RT. RT may be an excellent alternative for patients with contraindications to long-term treatment with steroids or NSAID.

Selenium in the treatment of head and neck lymphedema.

OBJECTIVE: To investigate the impact of selenium in the treatment of lymphedema of the head and neck region after radiotherapy alone or in combination with surgery. SUBJECTS AND MATERIALS: Between June 1996 and June 2001 a total of 36 cancer patients (29 male, 7 female; median age 61 years) were treated with selenium for persistent, extensive or progressive lymphedema of the head and neck region. Twenty had interstitial endolaryngeal edema associated with stridor and dyspnea. All patients received 350 microg/m(2) body surface sodium selenite medication p.o. daily (total dose 50 microg per day) for a period of 4-6 weeks after radiotherapy. The optimal effect of the selenium treatment was assessed after 4 weeks of therapy using the Miller score system. A visual analogue scale on a scale of 0-10 was used to assess the patient's quality of life prior to and after selenium. RESULTS: 75% of the patients had an improvement of the Miller score of one stage or more. The self-assessment of quality of life using the visual analogue scale improved significantly after selenium treatment with a reduction of 4.4 points (p < 0.05). Of the 20 patients with endolaryngeal edema tracheostomy was not necessary in 13 patients (65%), but 5 and 2 received a temporary or permanent tracheostomy, respectively. No episode of erysipelas was observed in all study patients. CONCLUSION: Our results suggest a short positive effect of sodium selenite on secondary head and neck lymphedema caused by radiotherapy alone or in combination with surgery.

[Use of complementary/alternative therapy methods by patients with breast cancer]. / Anwendung komplementärer/alternativer Therapiemassnahmen bei Patientinnen mit Brustkrebs.

BACKGROUND: Complementary/alternative medicine (CAM) is gaining increasing importance especially in the treatment of patients with breast carcinoma. The purpose of this analysis was to investigate the prevalence of CAM in patients with breast carcinoma, to statistically describe the preparations and therapies used, and to determine the reasons for their use, the source of information and the individual perception. PATIENTS AND METHODS: The statements of 203 patients with breast carcinoma who underwent radiotherapy were analyzed. The median age was 54 years (range 38-77 years). All patients underwent surgery as first therapy. 36 patients received a second-line radiotherapy because of metastases (27 patients) or local recurrence (9 patients). RESULTS: 159 patients (78%) stated to carry out an additional treatment. 31 out of the 36 patients with metastases or local recurrence used CAM. Vitamin preparations (67%), mistletoe therapy (59%), and mineral preparations (33%) were used most frequently. 70% of the patients used a combination of two or more preparations/therapies. The most cited reason for using CAM was the aim of increasing quality of life (28%) and improving the immune system (27%). 72% stated an improvement of their individual perception. The main source of information was the general practitioner or the gynecologist. CONCLUSION: The radiotherapist has to take these complementary/alternative therapies into consideration; their importance should be evaluated in further studies.

Spectroscopic gas analyzers based on indium-phosphide, antimonide and lead-salt diode-lasers.

Currently available semiconductor lasers for spectroscopy in the near- and mid-infrared region based on direct band-to-band transitions as gallium-arsenide, indium-phosphide, antimonides and lead-salt containing compounds will be discussed together with the main features of different tunable diode-laser absorption spectrometers for trace gas analysis. Measurements of atmospheric carbon dioxide with a room-temperature 2 microm indium-phosphide laser, applications of antimonide lasers for methane and formaldehyde sensing in the 3-4 microm range and a fast chemical sensor for methane flux measurements based on lead-salt diode-lasers operating near 7.8 microm will be presented.

[The multimodality therapy of advanced inoperable esophageal carcinoma. A retrospective analysis]. / Multimodale Therapie des fortgeschrittenen inoperablen Osophaguskarzinoms. Eine retrospektive Analyse.

BACKGROUND: The records of 161 patients with inoperable esophageal carcinoma were reviewed to determine the influence of concurrent radiochemotherapy and brachytherapy on overall survival. PATIENTS AND METHODS: From 1984 to 1999 161 patients suffering from advanced esophageal carcinoma Stage II to IV were treated with radiotherapy alone (131) or radiochemotherapy (30). In 48 patients additional brachytherapy was given. Median follow-up was 8 months (1 to 64 months), the median external beam doses was 51 Gy (18 to 66.6 Gy) and the median brachytherapy dose was 10 Gy (4 to 25 Gy). Chemotherapy consisted of cisplatin and 5-fluorouracil. RESULTS: Median survival for all patients was 10 months, 3-year survival rate 13% and the 5-year survival 5.2%. In univariate analysis the best results were achieved by concurrent radiochemotherapy with a median overall survival of 13 months, a 4-year survival of 18% (p = 0.0368), the combination of external radiotherapy and additional brachytherapy with a median overall survival of 14 months, a 4-year survival of 12.2% (p = 0.0008). After combination of concurrent radiochemotherapy and brachytherapy the 2-year survival rate is 58%. Multivariate analysis revealed simultaneous radiochemotherapy, external beam dose and additional brachytherapy as prognostic factors. Combination of concurrent radiochemotherapy and brachytherapy was possible without significant increase of local toxicity. CONCLUSIONS: Our retrospective analysis demonstrates that concurrent radiochemotherapy and additional brachytherapy are effective treatment schedules without significant increase of toxicity and may improve overall survival of patients with inoperable carcinoma of the esophagus. According to the results of this retrospective study, it would be appropriate to conduct a randomized trial to evaluate the benefit of combination of concurrent radiochemotherapy and brachytherapy.

[Prevention of radiation-induced diarrhea by smectite. Results of a double-blind randomized, placebo-controlled multicenter study]. / Prophylaxe der strahleninduzierten Diarrhö durch Smektit. Ergebnisse einer doppelblind randomisierten, plazebokontrollierten Multicenterstudie.

PURPOSE: Diarrhea and abdominal pain are well-known side effects abdominal or pelvic of radiation therapy that may lead to interruption of treatment in serious cases. In recent trials the silicate smectite has proven a promising drug in the prophylaxis of these adverse events. The presented trial aimed at the verification of earlier studies and the evaluation of a dose-effect relationship. PATIENTS AND METHODS: Between April 1994 and May 1995, a total of 176 patients obtaining radiotherapy of the pelvis or the abdomen were evaluated in a double-blind, randomized placebo-controlled investigation regarding the prophylactic effect of smectite (= Colina) against radiotherapy-induced diarrhea. During the whole period of radiotherapy 85 patients obtained 2 x 6 g smectite daily and 91 patients received 2 x 6 g placebo. The primary end point of the analysis was the time to the first appearance of diarrhea (> or = 3 pappy stools). RESULTS: All 176 patients were evaluated according to an intent-to-treat analysis. There was no significant difference between the prophylactic effects of smectite and placebo. For an explorative post-hoc analysis the total study group was split up into 2 subgroups, one with an irradiated small bowel volume < or = 837.5 ml, the other with a small bowel volume > 837.5 ml (median); the analysis indicated that the first subgroup showed a benefit for the smectite-treated patients in contrast to the placebo treatment (32 vs. 18 calendar days to the first appearance of diarrhea). This benefit was statistically not significant. CONCLUSION: Prophylactic application of smectite during irradiation of the pelvis and the abdomen can delay the development of radiotherapy-induced diarrhea, a statistical significance could not be verified neither in the total study group nor in the post-hoc subgroup analysis.

[First results of neoadjuvant simultaneious radiochemotherapy in advanced rectal carcinoma]. / Erste Ergebnisse der neoadjuvanten simultanen Radiochemotherapie bei fortgeschrittenen Rektumkarzinomen.

PURPOSE: In locally advanced rectal cancer tumor-negative margins often cannot be obtained by surgery alone. Nevertheless only patients with complete tumor resection can be cured. Due to the poor prognosis of patients with R1/R2 resection the "Deutsche Krebsgesellschaft" recommends concurrent preoperative radiochemotherapy for patients with locally advanced rectal cancer. PATIENTS AND METHODS: Between May 1997 and November 1999 22 patients were treated with preoperative radiochemotherapy. A total dose of 45 Gy with a small-volume boost of 5.4 Gy was delivered in conventional fractionation (single dose 1.8 Gy). On days 1 to 5 and 29 to 33 patients received concurrently 5-fluorouracil (5-FU) as continuous infusion of 1,000 mg/m2. If there was any sign of cardiac toxicity chemotherapy was changed to 5-FU/folinic acid or ralitrexed. RESULTS: Surgery following radiochemotherapy was performed in 19/22 patients. Resections with negative margins were achieved in 16/19 (84%) patients. Sphincter-conserving surgery was possible in 9/19 (47%) patients. A downstaging of at least 1 T category was found in 12/19 (63%) patients. With a median follow-up of 16 months no locoregional recurrences occurred in patients who underwent surgery. Two-year disease-free survival of resected patients is 62%, 2-year overall survival is 89%, of the whole population 76%. CONCLUSION: Preoperative radiochemotherapy followed by surgery is able to achieve clear resection margins in more than 70% of patients with locally advanced rectal cancer and may improve the rate of sphincter-conserving surgery.

Supportive use of amifostine in patients with head and neck tumors undergoing radio-chemotherapy. Is it possible to limit the duration of the application of amifostine?

BACKGROUND: Amifostine is a new cancer-supporting agent to protect normal tissue in patients receiving radio-chemotherapy. The main question of our study is whether the application of amifostine can be limited on the duration of chemotherapy in patients with advanced head and neck tumors undergoing radio-chemotherapy. PATIENTS AND METHODS: In a randomized study 14 patients were treated with amifostine (500 mg, day 1 to 5 and 29 to 33) during concurrent radio-chemotherapy with carboplatin (70 mg/m2, day 1 to 5 and 29 to 33), 14 patients were treated without amifostine. The analyzed parameters were dermatitis, mucositis, skin temperature, white blood and platelet count, creatinine and scintigram of salivary glands. Median survival of the amifostine group was 19 months, of the control group 10 months. RESULTS: There were no relevant differences in all analyzed parameters between both arms of the study. CONCLUSION: Our form of amifostine application is probably not able to obtain a relevant reduction of the toxicity of radio-chemotherapy.

[Simultaneous radiochemotherapy with carboplatin in patients with inoperable advanced stage III and IV head and neck tumors]. / Simultane Radiochemotherapie mit Carboplatin bei Patienten mit inoperablen fortgeschrittenen Kopf-Hals-Tumoren der Stadien UICC III and IV.

BACKGROUND: The results of treating advanced tumors in the head and neck region with radiotherapy alone are disappointing. Concurrent radiotherapy and chemotherapy may improve this situation. The treatment results of concurrent radiochemotherapy at the University of Rostock were analyzed retrospectively. PATIENTS AND METHODS: From 1991 to 1996 92 patients with head and neck tumors were treated with concurrent radiochemotherapy (1.8 to 63 Gy; 70 mg/m2 carboplatin day 1 to 5 and 29 to 33) with palliative tumor resection (n = 37) or without surgical treatment (n = 55). Remission rate, overall survival and disease-free survival, local control and acute toxicity were analyzed. RESULTS: Six weeks after radiochemotherapy 56.5% of patients had a complete remission, 36% a partial remission and 7.5% "no change". With a median follow-up of 42 months (6 to 74 months) overall survival, disease-free survival and local control were 24.3%, 28.9%, 18.0% 5 years after treatment. All these criteria were significantly better in patients with palliative tumor resection compared to no surgical treatment (uni- and multivariate) and in patients with Stage III than in patients with Stage IV carcinomas (univariate), overall survival was significantly better in patients with Stage III (multivariate). A pretherapeutic Hb level below 7.0 mmol/l (11.27 g/dl) reduced the local control significantly (uni- and multivariate). Grade III and IV mucositis was detected in 10%, Grade III leucopenia in 12% of treated patients. Grade IV leucopenia and Grade III thrombopenia were observed in 1 patient each. CONCLUSION: The toxicity of this treatment is tolerable. However, additional trials must be conducted before considering the palliative tumor resection as standard therapy.

Fluconazole prophylaxis in patients with head and neck tumours undergoing radiation and radiochemotherapy.

The aim of the present study was to investigate the incidence of Candida stomatitis and resulting interruptions in radiation and radiochemotherapy in 50 patients suffering from squamous cell carcinomas of the head and neck region receiving fluconazole (100 mg d-1) in comparison with a historical control group (n = 50) without specific prophylaxis. Twenty of the control patients (40%) demonstrated Candida stomatitis, with seven of them (14%) requiring interruptions in anticancer therapy. In contrast, none of the patients with fluconazole had evidence of Candida stomatitis (P = 0.0000051) and subsequent interruption of anti-cancer therapy (P = 0.0061). Laboratory monitoring for the presence of Candida species was performed in 30 patients before and after therapy with fluconazole. Candida albicans was identified less frequently after therapy when compared with the pretreatment status. However, C. glabrata and C. krusei were isolated in some of the patients, probably because of drug resistance of these subspecies. The results demonstrate the clinical usefulness of prophylactic fluconazole applications in patients suffering from head and neck tumours with the aim of reducing Candida stomatitis and the resulting interruptions in radiation and radiochemotherapy.

[Influence of reduction of radiation dosage on the incidence of radiation-induced pneumonitis, pulmonary fibrosis and pericarditis after mediastinal irradiation in the treatment of lymphogranulomatosis]. / Der Einfluss der Reduktion der Bestrahlungsdosis auf die Inzidenz der radiogenen Pneumonitis, Lungenfibrose und Perikarditis nach Mediastinalbestrahlung bei der Behandlung der Lymphogranulomatose.

BACKGROUND: The amount of radiation dose applied in the treatment of Hodgkin's disease is associated with the incidence of complications including radiation-induced pneumonitis, lung fibrosis and pericarditis. Therefore, from the beginning of 1986, we have started to apply a radiation therapy approach with reduced doses in order to minimize complications while maintaining effective treatment. PATIENTS AND METHOD: From 1983 through 1992 141 patients suffering from Hodgkin's disease were included in the present study. All of them were treated by radiation of mediastinum. In 126 cases polychemotherapy was applied before radiation. From 1986 we used a reduced radiation dose in cases that were treated by radiation alone (affected nodal regions with 40 Gy instead of 45 Gy and unaffected nodal regions with 36 Gy instead of 40 Gy) as well as after application of chemotherapy (affected nodal regions 36 Gy instead of 40 Gy and unaffected nodal regions with 30 Gy instead of 36 Gy). Ninety-five patients were treated according to the new therapy protocol. Forty-six patients had been treated with the higher dosages and served as the historical control group. Radiation therapy included Co-60, 15-MV and 9-MV photons, and 15-MeV and 9-MeV electrons. Serial thoracic X-ray controls were performed. CT scans, echocardiographic and electrocardiographic investigations were added in selected cases. RESULTS: During the period from 1983 to 1992, we diagnosed radiation-induced pneumonitis in 31% of the patients who underwent radiation therapy of the mediastinum. In addition, 16% demonstrated lung fibrosis and 10% pericarditis. After implementation of the reduced radiation dosages, the incidence of pneumonitis decreased from 35% to 24% (nearly significant in the 5% range), lung fibrosis from 24% to 12% (p < 0.05) and pericarditis from 26% to 2% (p < 0.01). The efficacy of treatment remained unaffected by the new therapy approach as has been demonstrated for cumulative survival data and recurrence-free intervals. CONCLUSIONS: Reduction of radiation dose in patients with Hodgkin's disease who undergo mediastinal radiation leads to a decrease in the incidence of radiation-induced complications (pneumonitis, lung fibrosis, pericarditis) whereas treatment efficacy remains unchanged.