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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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Efficacy of Synbiotics to Reduce Symptoms and Rectal Inflammatory Response in Acute Radiation Proctitis: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial.
Nascimento, M, Caporossi, C, Eduardo Aguilar-Nascimento, J, Michelon Castro-Barcellos, H, Teixeira Motta, R, Reis Lima, S
Nutrition and cancer. 2020;(4):602-609
Abstract
Purpose: Evaluate whether the daily intake of synbiotics improves symptoms and rectal/systemic inflammatory response in patients with radiation-induced acute proctitis.Methods and Materials: Twenty patients who underwent three-dimensional conformal radiotherapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri (108 CFU) and soluble fiber (4.3 g) or placebo. EORTC QLQ-PRT23 questionnaire was applied before the beginning of radiotherapy and after the fifth, sixth, and seventh weeks of treatment, and the sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores were compared. Fecal calprotectin was measured at Day 0 and in the fourth week of treatment, and serum C-reactive protein/albumin ratio were measured in the fourth week of treatment.Results: Both the complete and partial questionnaire score (median and range) were higher in the fifth and sixth weeks in the placebo group; there was a higher increase in fecal calprotectin in the placebo group and no difference comparing CRP/albumin ratio.Conclusions: Synbiotics reduce proctitis symptoms and improve quality of life by preventing rectal inflammation during radiotherapy for prostate cancer.
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Reduced radiation-induced toxicity by using proton therapy for the treatment of oropharyngeal cancer.
Meijer, TWH, Scandurra, D, Langendijk, JA
The British journal of radiology. 2020;(1107):20190955
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Abstract
Patients with squamous cell carcinoma of the oropharynx are generally treated with (chemo) radiation. Patients with oropharyngeal cancer have better survival than patients with squamous cell carcinoma of other head and neck subsites, especially when related to human papillomavirus. However, radiotherapy results in a substantial percentage of survivors suffering from significant treatment-related side-effects. Late radiation-induced side-effects are mostly irreversible and may even be progressive, and particularly xerostomia and dysphagia affect health-related quality of life. As the risk of radiation-induced side-effects highly depends on dose to healthy normal tissues, prevention of radiation-induced xerostomia and dysphagia and subsequent improvement of health-relatedquality of life can be obtained by applying proton therapy, which offers the opportunity to reduce the dose to both the salivary glands and anatomic structures involved in swallowing.This review describes the results of the first cohort studies demonstrating that proton therapy results in lower dose levels in multiple organs at risk, which translates into reduced acute toxicity (i.e. up to 3 months after radiotherapy), while preserving tumour control. Next to reducing mucositis, tube feeding, xerostomia and distortion of the sense of taste, protons can improve general well-being by decreasing fatigue and nausea. Proton therapy results in decreased rates of tube feeding dependency and severe weight loss up to 1 year after radiotherapy, and may decrease the risk of radionecrosis of the mandible. Also, the model-based approach for selecting patients for proton therapy in the Netherlands is described in this review and future perspectives are discussed.
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Randomized, Placebo-Controlled Clinical Trial Combining Pentoxifylline-Tocopherol and Clodronate in the Treatment of Radiation-Induced Plexopathy.
Delanian, SE, Lenglet, T, Maisonobe, T, Resche-Rigon, M, Pradat, PF
International journal of radiation oncology, biology, physics. 2020;(1):154-162
Abstract
PURPOSE Radiation-induced (RI) plexopathy is a rare peripheral nerve injury after radiation therapy for cancer. No treatment has been shown to slow its progression. A pentoxifylline-vitamin E combination significantly reduced RI fibrosis, and its association with clodronate (PENTOCLO) allowed healing of osteoradionecrosis and reduction of neurologic symptoms in phase 2 trials. METHODS AND MATERIALS A placebo-controlled, double-blind trial conducted in adults with RI limb plexopathy without cancer recurrence, randomized in 2 arms to PENTOCLO (pentoxifylline 800 mg, tocopherol 1000 mg, clodronate 1600 mg 5 days per week) or triple placebo. The primary outcome measure after 18 months of treatment was the neurologic Subjective Objective Management Analytic (SOMA) score evaluating pain, paresthesia, and motor disability. RESULTS Between 2011 and 2015, 59 patients were included: 1 false inclusion (neoplastic plexopathy), 29 treated with placebo (group P), and 29 treated with the active drugs (group A); 46 patients presented an upper-limb and 12 a lower-limb plexopathy. The mean delay after irradiation was 26 ± 8 years, for patients with neurologic symptoms for 5 ± 5 years. The median global SOMA scores in the P and A groups, respectively, were 9 (range, 6-11) versus 9 (range, 8-11) at M0 and 9 (range, 5-12) versus 10 (range, 6-11) at M18 without any significant difference. Analysis of the secondary outcomes showed that SOMA score subdomains for pain and paresthesia were more affected in group A (not significant). The frequency of adverse events was similar in the 2 groups (81% of patients): slight expected vascular-gastrointestinal symptoms in A, but a large excess of RI complications (arterial stenosis). CONCLUSIONS This first randomized drug trial in RI plexopathy failed to show a beneficial effect. More studies are needed in patients with less advanced disease and fewer confounding comorbidities and with a more sensitive measure to detect a therapeutic effect.
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Therapeutic potential of medicinal plants indicated by the Brazilian public health system in treating the collateral effects induced by chemotherapy, radiotherapy, and chemoradiotherapy: A systematic review.
de Almeida, EM, Ferreira, HJ, Alves, DR, da Silva, WMB
Complementary therapies in medicine. 2020;:102293
Abstract
OBJECTIVE This study, through a systematic review, evaluated the therapeutic effect of medicinal plants that were of interest to the Unified Health System (SUS) in treating the side effects induced by chemotherapy, radiotherapy and chemoradiotherapy in cancer patients. METHODOLOGY According to the PRISMA guidelines, a systematic search was conducted in the PubMed, Lilacs and Scopus databases from January 2009 to December 2018, using the groups of descriptors (Cancer OR Neoplasia OR Tumor) and (controlled clinical trial OR randomized clinical trial) associated with the scientific names of the 71 medicinal plants described in RENISUS. The study is registered in PROSPERO CRD42019129927. RESULTS Of the 29 articles selected, only 17 demonstrated the therapeutic potential of plants included in RENISUS to prevent or treat the side effects induced by chemotherapy, radiotherapy or chemoradiotherapy, either solely or through an adjuvant effect from drugs already used in the medical clinic. The two plant-based therapies that had the most studies exploring their therapeutic potential on side effects were Zingiber officinale and Aloe vera. CONCLUSION This study showed that some plants listed in RENISUS have shown preventive and curative potential on side effects induced by conventional treatments in patients with different types of cancer. Therefore, the use of scientifically proven herbal products, in conjunction with conventional therapies, can contribute to a better quality of life in cancer patients undergoing conventional treatments.
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Randomized, double-blind, placebo-controlled phase II trial of nanocurcumin in prostate cancer patients undergoing radiotherapy.
Saadipoor, A, Razzaghdoust, A, Simforoosh, N, Mahdavi, A, Bakhshandeh, M, Moghadam, M, Abdollahi, H, Mofid, B
Phytotherapy research : PTR. 2019;(2):370-378
Abstract
Clinical potential of curcumin in radiotherapy (RT) setting is outstanding and of high interest. The main purpose of this randomized controlled trial (RCT) was to assess the beneficial role of nanocurcumin to prevent and/or mitigate radiation-induced proctitis in prostate cancer patients undergoing RT. In this parallel-group study, 64 eligible patients with prostate cancer were randomized to receive either oral nanocurcumin (120 mg/day) or placebo 3 days before and during the RT course. Acute toxicities including proctitis and cystitis were assessed weekly during the treatment and once thereafter using CTCAE v.4.03 grading criteria. Baseline-adjusted hematologic nadirs were also analyzed and compared between the two groups. The patients undergoing definitive RT were followed to evaluate the tumor response. Nanocurcumin was well tolerated. Radiation-induced proctitis was noted in 18/31 (58.1%) of the placebo-treated patients versus 15/33 (45.5%) of nanocurcumin-treated patients (p = 0.313). No significant difference was also found between the two groups with regard to radiation-induced cystitis, duration of radiation toxicities, hematologic nadirs, and tumor response. In conclusion, this RCT was underpowered to indicate the efficacy of nanocurcumin in this clinical setting but could provide a considerable new translational insight to bridge the gap between the laboratory and clinical practice.
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Relationship between nutritional status and esophageal fistula formation after radiotherapy for esophageal cancer.
Watanabe, S, Ogino, I, Kunisaki, C, Hata, M
Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique. 2019;(3):222-227
Abstract
PURPOSE Chemoradiotherapy and radiotherapy for esophageal cancer sometimes cause esophageal fistulas. Esophageal fistulas often require additional procedures and are associated with a high mortality rate. The present study was conducted to determine the risk factors associated with esophageal fistulas in patients with esophageal cancer. PATIENTS AND METHODS We reviewed the cases of 206 patients who were treated with definitive radiotherapy for esophageal cancer. The planning dose, which ranged from 44 to 64.8Gy (median: 59.4Gy), was delivered to the primary lesion and regional lymph nodes. Descriptive statistics were calculated, and time-to-event analyses were performed using Cox proportional hazards regression analysis. RESULTS None of the 68 patients with T1 or T2 esophageal cancer developed esophageal fistulas. Among the 138 patients with T3 or T4 esophageal cancer, esophageal fistulas were detected in 20 (14.5%) patients. Multivariate analysis of the 138 patients with T3 or T4 esophageal cancer revealed low body mass index (BMI) to be an independent risk factor for esophageal fistula formation (P=0.0055). The optimal BMI cut-off value for predicting esophageal fistula formation was 20 kg/m2 (P=0.0121, odds ratio=4.130). CONCLUSION In patients with esophageal cancer treated with definitive radiotherapy, a BMI below20kg/m2 is a risk factor for esophageal fistula formation. A well-designed randomized controlled trial comparing the incidence of esophageal fistulas between patients with esophageal cancer who do and do not receive nutritional support before radiotherapy is required.
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The Potential Effects of Taurine in Mitigation of Radiation Nephropathy.
Ma, N, Kato, T, Isogai, T, Gu, Y, Yamashita, T
Advances in experimental medicine and biology. 2019;:497-505
Abstract
Taurine (2-aminoethanesulfonic acid) is a sulfur-containing organic acid possessing several important effects, including antioxidant and anti-inflammatory ones. Exposure to ionizing radiation generates free radicals and reactive oxygen species (ROS) in irradiated cells, and free radical generation leads to oxidative stress. It is known that radiation nephropathy includes an inflammation-based process in which ROS and cytokines are responsible. Different doses of explored radiation can cause apoptosis, inflammation and a profound oxidative stress in kidneys. Oxidative stress is involved in renal injury after exposure to both ionizing radiation and inflammation. In this review, we describe the protective effect of taurine against several kidney diseases and the potential effects of taurine in the mitigation of radiation nephropathy. We also report that X-irradiation decreased the expression of taurine and TauT in the kidney. Taurine administration suppressed the decrease in the expression of taurine and TauT in the kidney after radiation exposure. Taurine might contribute to the mitigation of kidney injury induced by radiation.
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Effects of a compound vitamin B mixture in combination with GeneTime® on radiation-induced oral mucositis.
Sun, H, Zhu, X, Li, D, Cheng, T
The Journal of international medical research. 2019;(5):2126-2134
Abstract
OBJECTIVE Both compound vitamin B mixtures and GeneTime® have been used in treatment of oral inflammation. This study aimed to assess the therapeutic effects of a compound vitamin B mixture combined with GeneTime® on radiation-induced oral mucositis. METHODS A total of 100 patients with radiation-induced oral mucositis were randomly divided into a control group (vitamin B alone; n = 50 patients) and an observation group (vitamin B plus GeneTime®, n = 50 patients). Clinical outcomes were compared between the two groups for the following 3 weeks. RESULTS The observation group had a significantly greater number of grade 0-I patients and significantly fewer grade II-IV patients than the control group. Among patients in the observation group, a significantly greater number of ulcers healed within 1-2 weeks, compared with those in patients in the control group. Significantly fewer ulcers healed among patients in the observation group at 3 weeks; notably, there were fewer ulcers to heal in the observation group, compared with the control group. CONCLUSIONS Use of a compound vitamin B mixture combined with GeneTime® exerted obvious therapeutic effects on radiation-induced oral mucositis and markedly shortened ulcer healing time. Therefore, this strategy may be useful in clinical applications.
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Effects of herbal medicine for xerostomia in head and neck cancer patients: an observational study in a tertiary cancer hospital.
Lim, RJ, Nik Nabil, WN, Chan, SY, Wong, YF, Han, LX, Gong, JY, Ho, KL, Shew, YS, Xu, L
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2019;(9):3491-3498
Abstract
PURPOSE More than 80% head and neck cancer patients endured radiotherapy-induced xerostomia which impacts their quality of life (QoL). This observational study evaluated the effect of herbal treatment on head and neck cancer patients' xerostomia and QoL. METHODS Head and neck cancer patients were recruited from July 2016 till March 2017 at National Cancer Institute, Ministry of Health, Malaysia. All study participants continued their standard oncology surveillance. Treatment group participants additionally received Chinese herbal treatment. The assessments included unstimulated salivary flow rate (USFR), stimulated salivary flow rate (SSFR), and QoL questionnaire. RESULTS Of 42 recruited participants, 28 were in the treatment group and 14 were in the control group. Participants were mainly Chinese (71.4%), stage III cancer (40.5%), and had nasopharynx cancer (76.2%). The commonly used single herbs were Wu Mei, San Qi, and Tian Hua Fen. Sha Shen Mai Dong Tang, Liu Wei Di Huang Wan, and Gan Lu Yin were the frequently prescribed herbal formulas. The baseline characteristics, USFR, SSFR, and QoL between control and treatment groups were comparable (p > 0.05). USFR between control and treatment groups were similar throughout the 6-month study period. SSFR for the treatment group significantly improved from 0.15 ± 0.28 ml/min (baseline) to 0.32 ± 0.22 ml/min (p = 0.04; at the 3rd month) and subsequently achieved 0.46 ± 0.23 ml/min (p = 0.001; at the 6th month). The treatment group had better QoL in terms of speech (p = 0.005), eating (p = 0.02), and head and neck pain (p = 0.04) at the 6th month. CONCLUSION Herbal treatment may improve xerostomia and QoL in post-radiotherapy head and cancer patients.