Randomized trial of a chlorhexidine mouthwash for alleviation of radiation-induced mucositis.

1994 ◽  
Vol 12 (12) ◽  
pp. 2630-2633 ◽  
Author(s):  
R L Foote ◽  
C L Loprinzi ◽  
A R Frank ◽  
J R O'Fallon ◽  
S Gulavita ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Oral Cavity ◽  
Strong Evidence ◽  
Clinical Situation ◽  
Receive Radiation Therapy ◽  
Double Blind ◽  
Radiation Induced ◽  
Taste Alteration ◽  
To Receive ◽  
Blind Manner

PURPOSE To determine whether a chlorhexidine mouthwash could alleviate radiation-induced oral mucositis. PATIENTS AND METHODS Patients scheduled to receive radiation therapy to include greater than one third of the oral cavity mucosa were selected for study. Following stratification, they were randomized in a double-blind manner to receive a chlorhexidine mouthwash or a placebo mouthwash. Both groups were then similarly evaluated for mucositis and mouthwash toxicity. RESULTS Twenty-five patients were randomized to receive the chlorhexidine mouthwash, while 27 received the placebo mouthwash. Treatment arms were well balanced. There was a trend for more mucositis and there was substantially more toxicity (eg, mouthwash-induced discomfort, taste alteration, and teeth staining) on the chlorhexidine arm. CONCLUSION In contrast to the prestudy hypothesis that a chlorhexidine mouthwash might provide benefit for patients receiving radiation therapy to the oral mucosa, this study provides strong evidence suggesting that a chlorhexidine mouthwash is detrimental in this clinical situation.

Placebo-controlled trial of sucralfate for inhibiting radiation-induced esophagitis.

1997 ◽  
Vol 15 (3) ◽  
pp. 1239-1243 ◽  
Author(s):  
W L McGinnis ◽  
C L Loprinzi ◽  
S J Buskirk ◽  
J A Sloan ◽  
R G Drummond ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Oral Solution ◽  
Study Medication ◽  
Double Blind ◽  
Thoracic Radiation ◽  
Gastrointestinal Side Effects ◽  
Radiation Induced ◽  
To Receive ◽  
Blind Manner

PURPOSE To determine whether a sucralfate oral solution can prevent/alleviate radiation-induced esophagitis. PATIENTS AND METHODS Patients included on this clinical trial were beginning thoracic radiation therapy to the mediastinum. Following stratification, they were randomized, in a double-blind manner, to receive a sucralfate solution or an identical-appearing placebo solution. Esophagitis was measured by physicians who used standard criteria and also by patients who used short questionnaires completed weekly during the course of the trial. RESULTS A total of 97 assessable patients were entered onto this clinical trial. During the first 2 weeks of the study, two placebo patients (4%) stopped their study medication, compared with 20 sucralfate patients (40%). This was related to substantially increased incidences of gastrointestinal toxicity (58% of sucralfate patients v 14% of placebo patients; P > .0001). There was no substantial benefit from the sucralfate in terms of esophagitis scores. CONCLUSION This oral sucralfate solution does not appear to inhibit radiation-induced esophagitis and is associated with disagreeable gastrointestinal side effects in this patient population.

Effect of Creatine Supplementation and a Lacto-Ovo-Vegetarian Diet on Muscle Creatine Concentration

2002 ◽  
Vol 12 (3) ◽  
pp. 336-348 ◽  
Author(s):  
Judith M. Lukaszuk ◽  
Robert J. Robertson ◽  
Judith E. Arch ◽  
Geoffrey E. Moore ◽  
Kenneth M. Yaw ◽  
...  
Keyword(s):  
Creatine Supplementation ◽  
Vegetarian Diet ◽  
Creatine Monohydrate ◽  
Double Blind ◽  
Healthy Men ◽  
Total Creatine ◽  
Muscle Creatine ◽  
To Receive ◽  
Blind Manner ◽  
Omnivorous Diet

The purpose of this investigation was to examine the effects of preceding oral creatine monohydrate with a lacto-ovo-vegetarian diet on muscle creatine concentration. Thirty-two healthy men, who regularly consumed an omnivorous diet, were randomly assigned to consume a weight maintaining, lacto-ovo-vegetarian (LOV; n = 16) or omnivorous (Omni; n = 16) diet for 26 days. In addition to their assigned diet, on day 22 of the study, subjects were assigned in a double-blind manner to receive either creatine monohydrate (CM; 0.3 g · kg · d−1 + 20 g Polycose) or an equivalent dose of placebo (PL) for 5 days. There were no significant differences between the LOV and Omni groups at baseline with respect to age, height, and weight. The results demonstrated that consuming a LOV diet for 21 days was an effective procedure to decrease muscle creatine concentration (p < .01) in individuals who normally consume meat and fish in their diet. However, muscle total creatine (TCr) following creatine supplementation did not differ statistically between LOV and Omni diet groups (148.6 ± 4.5 vs. 141.7 ± 4.5 mmol · kg−1 d.m.).

scholarly journals Personal innovative approach in radiation therapy of lung cancer- functional lung avoidance SPECT-guided (ASPECT) radiation therapy: a study protocol for phase II randomised double-blind clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Azza Ahmed Khalil ◽  
Eric Hau ◽  
Val Gebski ◽  
Cai Grau ◽  
Harriet Gee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Clinical Trial ◽  
Radiation Therapy ◽  
Radiation Dose ◽  
Pulmonary Toxicity ◽  
Double Blind ◽  
Curative Intent ◽  
Radiation Induced

Abstract Background Radiation therapy (RT) plays a key role in curative-intent treatment for locally advanced lung cancer. Radiation induced pulmonary toxicity can be significant for some patients and becomes a limiting factor for radiation dose, suitability for treatment, as well as post treatment quality of life and suitability for the newly introduced adjuvant immunotherapy. Modern RT techniques aim to minimise the radiation dose to the lungs, without accounting for regional distribution of lung function. Many lung cancer patients have significant regional differences in pulmonary function due to smoking and chronic lung co-morbidity. Even though reduction of dose to functional lung has shown to be feasible, the method of preferential functional lung avoidance has not been investigated in a randomised clinical trial. Methods In this study, single photon emission computed tomography (SPECT/CT) imaging technique is used for functional lung definition, in conjunction with advanced radiation dose delivery method in randomised, double-blind trial. The study aims to assess the impact of functional lung avoidance technique on pulmonary toxicity and quality of life in patients receiving chemo-RT for lung cancer. Eligibility criteria are biopsy verified lung cancer, scheduled to receive (chemo)-RT with curative intent. Every patient will undergo a pre-treatment perfusion SPECT/CT to identify functional lung. At radiation dose planning, two plans will be produced for all patients on trial. Standard reference plan, without the use of SPECT imaging data, and functional avoidance plan, will be optimised to reduce the dose to functional lung within the predefined constraints. Both plans will be clinically approved. Patients will then be randomised in a 2:1 ratio to be treated according to either the functional avoidance or the standard plan. This study aims to accrue a total of 200 patients within 3 years. The primary endpoint is symptomatic radiation-induced lung toxicity, measured serially 1–12 months after RT. Secondary endpoints include: a quality of life and patient reported lung symptoms assessment, overall survival, progression-free survival, and loco-regional disease control. Discussion ASPECT trial will investigate functional avoidance method of radiation delivery in clinical practice, and will establish toxicity outcomes for patients with lung cancer undergoing curative chemo-RT. Trial registration Clinicaltrials.gov Identifier: NCT04676828. Registered 1 December 2020.

Recovery of Transplanted Eyebrow From Radiation-Induced Anagen Effluvium

2015 ◽  
Vol 19 (4) ◽  
pp. 400-403
Author(s):  
Ekpemi Irune ◽  
Florian Bast ◽  
Gregory Williams ◽  
Niall Kirkpatrick
Keyword(s):  
Radiation Therapy ◽  
Skin Cancer ◽  
Facial Asymmetry ◽  
Hair Follicles ◽  
Ablative Surgery ◽  
The Face ◽  
Radiation Induced ◽  
To Receive

Ablative surgery for skin cancer of the face can often leave patients with significant deformities. These disfigurements can include loss of hair in conspicuous areas such as the eyebrows, leaving the patients with unsightly facial asymmetry. Eyebrow transplantation serves to address this issue; however, it has often been discouraged in patients who are destined to receive radiotherapy to the cutaneous area in question. This is due to the anagen effluvium effect of radiation therapy on hair follicles. We present a case in which the transplanted eyebrow hair follicles survived the deleterious effects of radiotherapy, leaving the patient with a symmetrical and aesthetically satisfactory eyebrow appearance.

Radiation-induced esophagitis: A double-blind randomized clinical trial of aluminum hydroxide plus magnesium hydroxide plus oxetacaine suspension versus aluminum hydroxide plus magnesium hydroxide suspension

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9100-9100
Author(s):  
F. Bruns ◽  
D. Riesenbeck ◽  
R. Muecke ◽  
M. Klasser ◽  
N. Willich
Keyword(s):  
Aluminum Hydroxide ◽  
Magnesium Hydroxide ◽  
Study Medication ◽  
First Line ◽  
Double Blind ◽  
Significant Difference ◽  
Radiation Induced ◽  
Acute Esophagitis ◽  
To Receive ◽  
First Line Treatment

9100 Background: To assess whether oral administered oxetacaine-containing suspension is effective in treating acute radiation- induced esophagitis in cancer patients. Methods: A double-blind, prospective-randomized clinical trial was conducted across 20 radiotherapy institutions in Germany. Patients [pts.] with head and neck or thoracic cancer without dysphagia/odynophagia received definitive or postoperative radiotherapy [RT] with or without chemotherapy including at least 5 cm of the esophagus in the high dose volume. Pts. were randomized to receive oral aluminum hydroxide plus magnesium hydroxide plus oxetacaine (Tepilta [T]) suspension or aluminum hydroxide plus magnesium hydroxide suspension without oxetacaine (Magaldrat [M]) as first-line treatment for acute radiation-induced esophagitis. Primary endpoint was the interval between begin of RT and failure of first-line treatment of esophagitis defined as need for additional systemic analgesics. Data on pts.’ symptoms were collected during and for at least 2 weeks after treatment. Results: A total of 158 pts. were randomized, of whom 103 had take at least one dose of the study medication for acute esophagitis = grade 2 (CTC). Of the 105 pts., 51 were randomized to receive T and 52 M. The cumulative incidence of acute esophagitis = grade 2 (CTC) was 25% for the T and 22% for the M arm. Kaplan-Meier analysis showed a statistically significant difference between the two groups regarding the need for systemic analgesics under consideration of the intake time in favor of T (p = 0.032). No statistically significant difference was found between the two groups regarding the secondary endpoints need respective delay of additional parenteral nutrition (p = 0.28 respective p = 0.12), and pts.`s and investigator`s estimation of global effectivity of the study medication (0.08 and 0.12). Conclusions: This trial demonstrated a statistically significant delay of the intake time for systemic analgesics in pts. randomized to receive oral aluminum hydroxide plus magnesium hydroxide plus oxetacaine suspension. No significant financial relationships to disclose.

Acute and long-term effects of once-daily oral bromocriptine and a new long-acting non-ergot dopamine agonist, quinagolide, in the treatment of hyperprolactinemia: A double-blind study

1991 ◽  
Vol 125 (4) ◽  
pp. 385-391 ◽  
Author(s):  
J. A. Verhelst ◽  
A. L. Froud ◽  
R. Touzel ◽  
J. A. H. Wass ◽  
G. M. Besser ◽  
...  
Keyword(s):  
Dopamine Agonist ◽  
Adverse Reactions ◽  
Double Blind Study ◽  
Long Term Effects ◽  
Double Blind ◽  
Once Daily ◽  
Long Acting ◽  
To Receive ◽  
Blind Manner

Abstract. Quinagolide (CV 205-502, Sandoz), an octahydrobenzo (g) quinoline, is a new non-ergot dopamine agonist which has specific D2 receptor activity and a long half-life, making it suitable for once-daily treatment. Recent uncontrolled reports have suggested that quinagolide may be successfully used for the clinical management of hyperprolactinemia with fewer adverse reactions than bromocriptine. This study is the first to compare quinagolide in a double-blind manner with bromocriptine, given only once-daily instead of the usual multidose regimen. In the first phase we compared, in 7 hyperprolactinemic patients, the effects over 24 h of a single oral dose of 0.05 mg quinagolide with 2.5 mg bromocriptine. Compared with placebo, both bromocriptine and quinagolide showed potent PRL-inhibiting and GH-releasing effects, with comparable effects at 24 h; no significant changes were observed in TSH, LH, FSH or cortisol. Twelve hyperprolactinemic patients were then randomized to receive either once-daily bromocriptine or quinagolide in incremental doses for a period of six months. Both drugs were found to be equally effective, and no differences were seen either in adverse reactions or PRL levels during repeated diurnal sampling. We therefore conclude that quinagolide and bromocriptine are therapeutically equivalent in long-term use, and both are equally effective when given once a day. However, some patients intolerant of bromocriptine may respond better to quinagolide, and vice versa.

scholarly journals Gastrointestinal Tolerance and Protein Absorption Markers with a New Peptide Enteral Formula Compared to a Standard Intact Protein Enteral Formula in Critically Ill Patients

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2362
Author(s):  
Ione de Brito-Ashurst ◽  
Marianne Klebach ◽  
Eleni Tsompanaki ◽  
Sundeep Kaul ◽  
Peter van Horssen ◽  
...  
Keyword(s):  
Tube Feeding ◽  
Intact Protein ◽  
Gastric Residual Volume ◽  
Double Blind ◽  
Urinary Markers ◽  
Protein Absorption ◽  
Gastrointestinal Tolerance ◽  
Enteral Formula ◽  
To Receive ◽  
Blind Manner

The aim of this exploratory study was to investigate gastrointestinal tolerance and protein absorption markers with a new enteral peptide formula (PF) compared to an isocaloric enteral intact protein standard formula (SF) containing the same amount of protein in ICU patients. Patients admitted to a cardio-thoracic intensive care unit expected to receive tube feeding for ≥5 days were randomized to receive either PF (1.5 kcal/mL) or SF in a double-blind manner for ≤14 days. Twenty-six patients were randomized (13 SF and 13 PF) and 23 (12 SF and 11 PF) completed at least 5 days of product administration. There were no statistically significant differences between the feeds during the first 5 days of intervention for diarrhea (SF:3 (23%); PF:5 (39%), p = 0.388), vomiting (SF:1 (8%); PF:2 (15%), p = 0.549), constipation (SF:7 (54%), PF:3 (23%), p = 0.115), and high gastric residual volume (>500 mL: SF:1 (8%); PF: 2 (15%), p = 0.535). There were no differences in plasma amino acids or urinary markers of protein absorption and metabolism. In conclusion, no major differences were found in tolerability and protein absorption markers between the standard intact protein formula and the peptide formula.

scholarly journals Phase III, Double-Blind Study of Depot Octreotide Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy: Results of North Central Cancer Treatment Group N00CA

2008 ◽  
Vol 26 (32) ◽  
pp. 5248-5253 ◽  
Author(s):  
James A. Martenson ◽  
Michele Y. Halyard ◽  
Jeff A. Sloan ◽  
Gary M. Proulx ◽  
Robert C. Miller ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Gastrointestinal Symptoms ◽  
Phase Iii ◽  
Double Blind Study ◽  
Double Blind ◽  
North Central ◽  
Pelvic Radiation ◽  
Patient Reported ◽  
Bowel Movements ◽  
To Receive

PurposeTo assess the effectiveness of depot octreotide for the prevention of diarrhea during pelvic radiation therapy.Patients and MethodsPatients receiving pelvic radiation therapy (planned minimum dose, 45 Gy; 1.7 to 2.1 Gy daily) were eligible for the study. From May 10, 2002, through October 14, 2005, 125 patients were randomly allocated in a double-blind fashion to receive octreotide (100 μg, administered subcutaneously on day 1, followed by depot octreotide, 20 mg, administered intramuscularly on days 2 and 29; n = 62) or to receive a placebo (n = 63).ResultsGrade 0, 1, 2, and 3 diarrhea were observed in 18%, 31%, 31%, and 21% of patients in the octreotide arm, respectively, and in 25%, 32%, 22%, and 21% of patients in the placebo arm, respectively (P = .64). Grade 0, 1, 2, and 3 abdominal cramps were observed in 32%, 45%, 21%, and 2% of patients receiving octreotide, respectively, and in 51%, 24%, 21%, and 5% of patients receiving the placebo, respectively (P = .053). Some patient-reported symptoms were worse in the octreotide group, including nocturnal bowel movements (70% v 45%; P = .004), clustering of bowel movements (90% v 69%; P = .004), and bleeding with bowel movements (57% v 35%; P = .01).ConclusionAs administered in this study, octreotide did not decrease diarrhea during pelvic radiation therapy. Some gastrointestinal symptoms were worse in patients treated with octreotide. Octreotide is not indicated for prevention of diarrhea during pelvic radiation therapy.

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