Oral hygiene grade and quality of life in children with chemotherapy-related oral mucositis: a randomized study on the impact of a fluoride toothpaste with salivary enzymes, essential oils, proteins and colostrum extract versus a fluoride toothpaste witho

AbstractMental health problems (MHPs) are very common in the elderly and can have an important influence on their quality of life (QoL). There is almost no data on the impact of clinical pharmacists’ (CPs) interventions on the QoL including elderly patients and MHPs. The main aim of this study was to determinate the impact of (CP’s) interventions on the QoL and quality of pharmacotherapy. A prospective non-randomized pre-post study was designed which included residents of a nursing home aged 65 age or more with at least one MHP. Each patient also filled out the EQ-5D questionnaire. The medical review MR included drug-related problems (DRPs) and potentially drug-drug interactions (pDDIs), as well as potentially inappropriate medications (PIMs). After 2 months, the participants were interviewed again. The mean number of medications before the intervention was 12,2 ± 3,1 per patient and decreased to 10,3 ± 3,0 medications per patient (p < 0,05) (n = 24). The total number of PIMs and pDDIs was also reduced and QoL was also significantly higher (p < 0,05). A collaborative care approach with a CP led to a decrease of DRPs, pDDIs, PIMs, the total number of medications and to an improvement in the patients’ QoL.

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PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) versus observation in patients with localized renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN 8143).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.7_suppl.tps684 ◽

2019 ◽

Vol 37 (7_suppl) ◽

pp. TPS684-TPS684 ◽

Cited By ~ 3

Author(s):

Lauren Christine Harshman ◽

Maneka Puligandla ◽

Naomi B. Haas ◽

Mohamad Allaf ◽

Charles G. Drake ◽

...

Keyword(s):

Quality Of Life ◽

Overall Survival ◽

Immune System ◽

Clinical Outcomes ◽

Clinical Stage ◽

Randomized Study ◽

Phase Iii ◽

The Impact ◽

Metastatic Rcc

TPS684 Background: The anti-PD-1 antibody nivo improves overall survival in metastatic RCC and is well tolerated. There is no standard adjuvant systemic therapy that increases overall survival (OS) over surgery alone for non-metastatic RCC. Priming the immune system prior to surgery with anti-PD-1 has shown an OS benefit compared to a pure adjuvant approach in mouse solid tumor models. The PROSPER RCC trial aims to improve clinical outcomes by priming the immune system prior to nephrectomy with neoadjuvant nivo and continued engagement with adjuvant blockade in patients with high risk M0 RCC compared to surgery alone. Methods: This global, unblinded, phase 3 National Clinical Trials Network study is currently accruing patients with clinical stage ≥T2 or node positive M0 RCC of any histology. Tumor biopsy prior to randomization is mandatory to ensure RCC and permits in depth correlative science. The investigational arm will receive two doses of nivo 240mg prior to surgery followed by adjuvant nivo for 9 months (q2 wks x 3 mo followed by 480mg q4 wks x 6 mo). The control arm will undergo standard nephrectomy followed by observation. Randomized patients are stratified by clinical T stage, node positivity, and histology. To enhance accrual and patient quality of life, key upcoming amendments are being instituted. These include biopsy only in the nivo arm, allowance of oligometastatic disease and bilateral renal masses that can be fully resected/ablated, and change of nivo dosing to q4 wks (1 neoadj; 9 adj). With accrual of 766 patients, there is 84.2% power to detect a 14.4% absolute benefit in recurrence-free survival (RFS) at 5 years assuming the ASSURE historical control of ~56% to 70% (HR = 0.70). The study is also powered to evaluate a significant increase in overall survival (HR 0.67). Safety, feasibility, and quality of life endpoints critical to adjuvant therapy considerations are incorporated. PROSPER RCC embeds a wealth of translational work aimed at investigating the impact of the baseline immune milieu, the changes induced by neoadjuvant anti-PD-1 priming, and how both correlate with clinical outcomes. Clinical trial information: NCT03055013.

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Oral Health Related Quality of Life in an Adult Jamaican Population

Caribbean Medical Journal ◽

10.48107/cmj.2020.12.009 ◽

2020 ◽

Author(s):

Michelle Brown ◽

Candace Lockhart ◽

Biney Thomas ◽

Rafaela Rech

Keyword(s):

Quality Of Life ◽

Oral Health ◽

Health Related Quality ◽

Physical Pain ◽

Fluoride Toothpaste ◽

Related Quality ◽

Health Related ◽

The Mean ◽

The Impact

Objectives The aim of this study is to evaluate the impact of sociodemographic characteristics, oral health status and behaviours on Oral Health Related Quality of Life (OHRQoL) on an adult Jamaican population. Methods Adults who presented for treatment at the UWI Mona Dental Polyclinic participated in this cross-sectional study. Participants responded to a structured questionnaire consisting of sociodemographic and oral hygiene habits and were also examined for the presence of decayed, missing and filled teeth (DMFT). OHRQoL was assessed using the Oral Health Impact Profile (OHIP-14) questionnaire. Descriptive statistical analysis, univariate and multiple Poisson Regression with robust variance were performed to identify the factors impacting OHRQoL. Results The study sample consisted of 120 adults between the ages of 18-59 years. The mean OHIP-14 score was 9.81 (±9.06), 24% presented impaired OHRQoL and 76% presented frequent impaired OHRQoL. The most prevalent domain was physical pain (80%) followed by psychological discomfort (59%) and the mean DMFT score was 9.92 (±8.78). In the adjusted logistic regression, participants aged between 29-46 years (PR 0.58, CI 0.37-0.90, p= 0.016) and the use of fluoride toothpaste (PR 0.52, 95%, CI 0.35- 0.77, p = 0.001) were negatively associated with OHRQoL. Conclusion Physical pain was the dimension that most impacted domain in OHRQoL. The most negative OHRQoL was associated with the 29 to 46 years age-group and the use of fluoride toothpaste. These findings are important for oral health strategies in this population.

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PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) versus observation in patients with renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN 8143).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.tps4597 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. TPS4597-TPS4597 ◽

Cited By ~ 1

Author(s):

Lauren Christine Harshman ◽

Maneka Puligandla ◽

Naomi B. Haas ◽

Mohamad Allaf ◽

Charles G. Drake ◽

...

Keyword(s):

Quality Of Life ◽

Immune System ◽

Clinical Outcomes ◽

Clinical Stage ◽

Randomized Study ◽

Phase Iii ◽

Perioperative Therapy ◽

The Impact ◽

Metastatic Rcc

TPS4597 Background: The anti-PD-1 antibody nivo improves overall survival (OS) in metastatic RCC and is well tolerated. There is no standard adjuvant (adjuv) systemic therapy that increases OS over surgery alone for non-metastatic RCC. Priming the immune system prior to surgery with anti-PD-1 has shown an OS benefit compared to a pure adjuv approach in mouse solid tumor models. Multiple ph 2 studies in bladder, lung and breast cancers have shown remarkable pathologic responses with neoadjuvant (neoadj) PD-1 blockade. Two ongoing ph 2 studies of perioperative nivo in M0 RCC patients are showing preliminary feasibility and safety with no surgical delays (NCT02575222; NCT02595918). PROSPER RCC (NCT03055013) aims to improve clinical outcomes by priming the immune system prior to nephrectomy with neoadj nivo and continued engagement with adjuv blockade in patients with high risk RCC compared to surgery alone. Methods: This global, unblinded, phase 3 National Clinical Trials Network study is currently accruing patients with clinical stage ≥T2 or TanyN+ RCC of any histology planned for nephrectomy. Oligometastases are permitted if can be rendered NED. We amended the study to enhance accrual and patient quality of life by changing nivo dosing to 480mg q4 wks and requiring baseline tumor biopsy only in the nivo arm. The investigational arm receives 1 dose of nivo prior to surgery followed by 9 adjuv doses. The control arm undergoes standard nephrectomy followed by observation. Randomized patients are stratified by clinical T stage, node positivity, and M stage. Accrual of 805 patients provides 84.2% power to detect a 14.4% absolute benefit in recurrence-free survival (RFS) at 5 years assuming the ASSURE historical control of ~56% to 70% (HR = 0.70). The study is powered to evaluate a significant increase in OS (HR 0.67). Critical perioperative therapy considerations such as safety, feasibility, and quality of life endpoints have been integrated. PROSPER RCC embeds a wealth of translational work aimed at investigating the impact of the baseline immune milieu, the changes induced by neoadjuvant anti-PD-1 priming, and how both may predict clinical outcomes. Clinical trial information: NCT03055013.

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Oral Mucositis Incidence and Severity after Methotrexate and Non-Methotrexate Containing GVHD Prophylaxis Regimens.

Blood ◽

10.1182/blood.v104.11.351.351 ◽

2004 ◽

Vol 104 (11) ◽

pp. 351-351 ◽

Cited By ~ 3

Author(s):

Corey Cutler ◽

Shuli Li ◽

Haesook T. Kim ◽

Patricia Laglenne ◽

Colleen Ford ◽

...

Keyword(s):

Quality Of Life ◽

Stem Cell ◽

Stem Cell Transplantation ◽

Hospital Discharge ◽

Cell Transplantation ◽

Oral Mucositis ◽

Gvhd Prophylaxis ◽

Hospital Days ◽

The Impact

Abstract Oral mucositis (OM) occurs in up to 75% of recipients of high-dose chemoradiotherapy conditioning regimens prior to allogeneic hematopoietic stem cell transplantation (HSCT). OM affects patient quality of life by causing oropharyngeal pain, and by impairing communication and swallowing. As a result, narcotic analgesia and total parenteral nutrition (TPN) are commonly required in the recovery period after HSCT. Methotrexate (MTX), an antiproliferative agent used as GVHD prophylaxis, impairs mucosal regeneration after conditioning-related injury, and worsens and prolongs OM. We assessed the impact of sirolimus, a novel immunosuppressive agent used in lieu of MTX for GVHD prophylaxis, on outcomes associated with OM. Methods: Two cohorts of patients were prospectively analyzed for OM severity, and chart reviews were performed to assess correlative outcomes. All patients underwent HLA-matched sibling PBSC transplantation after Cy-TBI conditioning. GVHD prophylaxis consisted of sirolimus/tacrolimus (ST) in the study group and tacrolimus/methotrexate (TM) in the control group. OM was assessed 3x/week using a prospectively validated 6-point assessment tool, by members of the Oral Medicine Service. At each assessment, the evaluators systematically evaluated for the presence of erythema and ulceration of the oral mucosa at nine pre-defined locations within the oral cavity. The use of narcotics and TPN was recorded from the time of transplantation to hospital discharge. Results: 30 patients received ST and 24 patients received TM as GVHD prophylaxis after HLA-matched PBSCT between 10/2000 and 5/2003. The two groups were balanced for demographic variables, including age, sex, and disease status at transplant. OM severity was reduced in the ST group. Mild, moderate and severe OM was noted in 37, 57 and 7% of the ST group and 8, 42 and 50% of the TM group (p=0.0002). As a result, TPN use was reduced in the ST group (17 vs. 43% of hospital days, p=0.02), and a higher proportion of subjects required no TPN in the ST group (47 vs. 21%, p=0.08). The total number of hospital days where narcotics were required for pain control was lower in the ST group in comparison with the TM group (14 vs. 16 days median, p = NS). The time from transplant to first hospital discharge was shorter in the ST group compared with the TM group (18 vs. 22 days median, p= 0.07) Conclusions: The use of ST for GVHD prophylaxis is associated with less severe oropharyngeal mucositis than TM, despite equivalent conditioning regimen intensity. As a result, TPN use was reduced, narcotic use was reduced and the duration of hospitalization was shortened. The use of less toxic GVHD regimens without MTX may have significant impact on patient quality of life, patient outcomes and economic outcomes associated with allogeneic stem cell transplantation.

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The Impact of Non-Steroidal Anti-Inflammatory Agents after Phacoemulsification on Quality of Life: A Randomized Study

Ophthalmology and Therapy ◽

10.1007/s40123-016-0073-3 ◽

2016 ◽

Vol 6 (1) ◽

pp. 133-140 ◽

Cited By ~ 2

Author(s):

Irini P. Chatziralli ◽

Theodoros N. Sergentanis ◽

Efstratios A. Parikakis ◽

Leonidas E. Papazisis ◽

Panagiotis Mitropoulos ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Study ◽

Anti Inflammatory ◽

The Impact

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First results of a prospective randomized study on the impact of psychooncological intervention in cancer patients on quality of life and endocrino-immunological parameters

European Journal of Cancer ◽

10.1016/s0959-8049(01)81081-9 ◽

2001 ◽

Vol 37 ◽

pp. S162

Author(s):

M.M. Determann ◽

H. Kalthoff ◽

V.E. Kollenbaum ◽

N. Zavazava ◽

L. Jochimsen ◽

...

Keyword(s):

Quality Of Life ◽

Cancer Patients ◽

Randomized Study ◽

Prospective Randomized Study ◽

Immunological Parameters ◽

First Results ◽

The Impact

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Quality of Life After Sialendoscopy: Prospective Non-Randomized Study

10.21203/rs.3.rs-679845/v1 ◽

2021 ◽

Author(s):

Giulianno Molina de Melo ◽

Murilo Catafesta das Neves ◽

Marcello Rosano ◽

Christiana Maria Ribeiro Salles Vanni ◽

Marcio Abrahao ◽

...

Keyword(s):

Quality Of Life ◽

Positive Impact ◽

Randomized Study ◽

Health Impact ◽

Young Female ◽

Stone Disease ◽

Symptom Duration ◽

Almost All ◽

The Impact

Abstract Background: The symptomatic (swelling and pain) salivary gland obstructions are caused by sialolithiasis and salivary duct stenosis, negatively affecting quality of life (QOL), with almost all candidates for clinical measures and minimally invasive sialendoscopy. The impact of sialendoscopy treatment on the QOL has been little addressed nowadays. The objective is to prospectively evaluate the impact of sialendoscopy on the quality of life of patients undergoing sialendoscopy due to benign salivary obstructive diseases, measured through QOL questionnaires of xerostomia degree, the oral health impact profile and post sialendoscopy satisfaction questionnaires. Result: 37 sialendoscopies were included, most young female: 64.5% sialolithiasis, 35.4% post-radioiodine; 4.5 times/week painful swelling; 23.5 months symptom duration; pre- and post-sialendoscopy VAS values: 7.42 to 1.29 (p<0.001); 86.5% and 89.2% were subjected to sialendoscopy alone and endoscopic dilatation respectively; 80.6% reported improved symptoms after sialendoscopy in the sialolithiasis clinic (p<0.001). The physical pain and psychological discomfort domain scores were mostly impacted where sialendoscopy provided relief and improvement (p<0.001). We found a positive correlation between sialendoscopy and obstructive stone disease (p<0.001) and no correlation in sialendoscopy satisfaction in xerostomia patients (p=0.009).Conclusions: We found improved symptoms with overall good satisfaction after sialendoscopy correlated with stones; and a negative correlation between xerostomia. Our findings support the evident indication of sialendoscopy for obstructive sialolithiasis with a positive impact on QOL and relative indication to xerostomia that barely improved QOL satisfaction.Trial Registration: WHO Universal Trial Number (UTN): U1111-1247-7028 Brazilian Clinical Trials Registry (ReBeC): RBR-6p8zfs

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Randomized Study of the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group Comparing Quality of Life in Patients With Ovarian Cancer Treated With Cisplatin/Paclitaxel Versus Carboplatin/Paclitaxel

Journal of Clinical Oncology ◽

10.1200/jco.2005.02.4067 ◽

2006 ◽

Vol 24 (4) ◽

pp. 579-586 ◽

Cited By ~ 59

Author(s):

Elfriede R. Greimel ◽

Vesna Bjelic-Radisic ◽

Jacobus Pfisterer ◽

Felix Hilpert ◽

Fedor Daghofer ◽

...

Keyword(s):

Quality Of Life ◽

Ovarian Cancer ◽

Cancer Patients ◽

Randomized Study ◽

Progression Free Survival ◽

Phase Iii ◽

Response To Treatment ◽

Free Survival ◽

The Impact

Purpose The objective of this study was to compare the quality of life (QoL) of ovarian cancer patients treated with paclitaxel/carboplatin (TC) versus paclitaxel/cisplatin (PT) and to determine the impact of treatment toxicity on the various QoL domains. Patients and Methods In this phase III trial, 798 patients with ovarian cancer stages IIB-IV were randomly assigned to receive TC or PT. The primary end point was progression-free survival; secondary end points included toxicity, QoL, and response to treatment. Patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30 before treatment, within 3 days before the second and the fourth chemotherapy cycle, and 3 weeks after completion of chemotherapy. Results Previously reported data showed that patients undergoing TC or PT did not differ in progression-free survival and overall survival. However, the TC arm was superior, indicating a better overall QoL compared with the PT arm. Controlling for toxicity and age, a significant treatment by assessment time interaction was found for four QoL functioning scales and three symptoms scales. Patients in the TC arm showed better means scores after treatment on overall QoL (P = .012), physical functioning (P = .012), role functioning (P = .005), and cognitive functioning (P = .024), compared with the PT arm. Concerning symptom experience, patients undergoing TC showed less nausea and vomiting (P < .001), less appetite loss (P < .001), and less fatigue (P = .033) after completion of treatment compared with patients undergoing PT. Conclusion The TC regimen achieved better QoL outcomes compared with the PT regimen. Thus, clinicians may consider replacing cisplatin with carboplatin when treating ovarian cancer patients with chemotherapy.

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