Perception and knowledge of clinical trials and factors affecting participation of regional and rural cancer patients of North Queensland

e17558 Background: The best treatment option for most cancers is participation in clinical trials. Participation in trials is generally low and among rural patients it is likely to be even lower. The aim of this study was to assess knowledge about and attitudes towards clinical trials among rural and regional cancer patients of North Queensland. Methods: A questionnaire-based survey was conducted in outpatient clinics at the Townsville Cancer Centre on all types of cancer patients. Results: The mean age of the 178 participants was 56 years and 45.4% lived in rural or remote areas. Median distance to the trial centre (Townsville) for rural participants was 180 km (range 80 - 1300 km). Being asked whether they would take part in a RCT, 13.2% of participants said no, 56.3% said yes, and 30.5% were unsure. There were no significant relationships between willingness to participate and rurality (p = 0.896) or education level (p = 0.943). For the majority of patients, the number of clinic visits and blood tests required did not matter. Cost of travel (41.1% rural/remote; 23.5% regional; p < 0.001) and the need for family or friends to accompany (38.9% rural/remote; 24.1% regional; p = 0.021) were more important for rural/remote than regional patients as factors affecting participation. Only 16.4% of participants were aware of early studies. After education, percentage of patients willing to participate in phase I and II studies were 57% and 84%, respectively. Rural patients were less willing to participate in phase I studies than regional patients (33.9% vs 52.6%, p = 0.029). Conclusions: Rural patients are as interested in participating in clinical trials as urban patients except for phase 1 trials and should not be excluded because of rurality. Knowledge of trials is poor and there is a need for education early. Cost of travel seems more important for rural patients and as such budgets should include cost of travel to encourage participation of rural patients. No significant financial relationships to disclose.

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Information sources cancer patients use to find out about phase I and II clinical trials: An exploratory pilot feasibility study

Journal of Clinical Oncology ◽

10.1200/jco.2008.26.15_suppl.20731 ◽

2008 ◽

Vol 26 (15_suppl) ◽

pp. 20731-20731

Author(s):

D. Casa ◽

B. F. Piper ◽

M. J. Borad ◽

J. Hepworth ◽

S. P. Anthony ◽

...

Keyword(s):

Clinical Trials ◽

Phase I ◽

Cancer Patients ◽

Feasibility Study ◽

Information Sources ◽

Pilot Feasibility Study ◽

Phase I And Ii

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Continuous intravenous vitamin C in the cancer treatment: re-evaluation of a Phase I clinical study

Functional Foods in Health and Disease ◽

10.31989/ffhd.v9i3.590 ◽

2019 ◽

Vol 9 (3) ◽

pp. 180

Author(s):

Nina Mikirova ◽

Joseph Casciari ◽

Ronald Hunninghake

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Vitamin C ◽

Phase I ◽

Cancer Patients ◽

Phase 1 ◽

Cancer Prognosis ◽

Sodium Ascorbate ◽

High Dose ◽

Treatment Schedule

Background: Intravenous high-dose vitamin C (IVC) therapy is widely used in naturopathic and integrative oncology. A number of Phase I and Phase II clinical trials were launched to prove the benefits of the IVC therapy. Many case studies demonstrated the effectiveness of IVC, with various degrees of success. Clinical trials using IVC to treat cancer have, to date, demonstrated its safety without conclusively proven its efficacy. One difficulty in administering IVC is determining the optimal treatment schedule. To this end, data from a previous Phase 1 clinical trial conducted in 1998 using continuous vitamin C infusions was analyzed to examine the effects of this regimen on key prognostic parameters. Method: Twenty-four subjects were given continuous IVC at doses between 150 and 710 mg/kg/day. Most of the patients had colon cancer with liver and lung metastasis and three patients had pancreatic or liver cancer. All patients had several chemotherapy/radiation treatments before entering the study. Patients were treated by pharmaceutical grade sodium ascorbate diluted in Lactated Ringers solution with the rate of infusion of 20 ml/hr or 10 ml/hr for lower doses. This diluted solution was administered by continuous infusion.Results: Prior to treatment, serum lymphocyte counts and ascorbate concentrations tended to be low while serum levels of lactate dehydrogenase (LDH), neutrophils, and glucose tended to be high. Improvements were seen during IVC therapy. In patients with initially elevated neutrophil levels, numbers tended to decrease. In contrast, increased absolute neutrophil and lymphocyte numbers were seen in patients with initially low counts. Neutrophil to lymphocyte ratios (NLR) proved to be a good indicator of cancer patients’ survival times (high NLR, low survival). This was also true of LDH, creatinine, and glucose concentrations. In patients with the highest pre-treatment NLR, rate of growth of this ratio decreased significantly during therapy. IVC treatments were also associated with decreases in glucose concentrations, restoration of vitamin C levels, and, in about 40% of cases, reductions in LDH levels. Conclusions: As the result of the study we found that continuous IVC infusions improved several parameters associated with poor cancer prognosis. The data suggests a strategic benefit to using lower IVC doses in continuous infusions: raising the dose above 300 mg/kg/day (20 grams in 70 kg human) increased the frequency of side effects without noticeably increasing plasma ascorbate levels. Moreover, improvements in lymphocyte counts at low IVC doses tended to decrease at the higher doses. In conclusion, continuous infusions had benefits to cancer patients and further research in this area is warranted.Keywords: ascorbic acid; continuous infusion; cancer patients; clinical trial; lymphopenia; neutrophil to lymphocyte ratio; hyperglycemia; safety.

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Zoledronic acid in cancer patients with bone metastases: Results of Phase I and II trials

Seminars in Oncology ◽

10.1053/sonc.2001.24157 ◽

2001 ◽

Vol 28 (2C) ◽

pp. 25-34 ◽

Cited By ~ 1

Author(s):

James R. Berenson

Keyword(s):

Zoledronic Acid ◽

Phase I ◽

Bone Metastases ◽

Cancer Patients ◽

Phase I And Ii

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Osteosarcoma Pathogenesis Leads the Way to New Target Treatments

International Journal of Molecular Sciences ◽

10.3390/ijms22020813 ◽

2021 ◽

Vol 22 (2) ◽

pp. 813

Author(s):

Isabel Fernandes ◽

Cecília Melo-Alvim ◽

Raquel Lopes-Brás ◽

Miguel Esperança-Martins ◽

Luís Costa

Keyword(s):

Clinical Trials ◽

Phase I ◽

Poor Prognosis ◽

Therapeutic Targets ◽

Rare Condition ◽

Basic Research ◽

Metastatic Setting ◽

Phase I And Ii ◽

The Way

Osteosarcoma (OS) is a rare condition with very poor prognosis in a metastatic setting. Basic research has enabled a better understanding of OS pathogenesis and the discovery of new potential therapeutic targets. Phase I and II clinical trials are already ongoing, with some promising results for these patients. This article reviews OS pathogenesis and new potential therapeutic targets.

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Cross-trial Analysis of Immunologic and Clinical Data Resulting From Phase I and II Trials of MVA-5T4 (TroVax) in Colorectal, Renal, and Prostate Cancer Patients

Journal of Immunotherapy ◽

10.1097/cji.0b013e3181f5dac7 ◽

2010 ◽

Vol 33 (9) ◽

pp. 999-1005 ◽

Cited By ~ 27

Author(s):

Richard Harrop ◽

William Shingler ◽

Michelle Kelleher ◽

Jackie de Belin ◽

Peter Treasure

Keyword(s):

Prostate Cancer ◽

Phase I ◽

Cancer Patients ◽

Clinical Data ◽

Trial Analysis ◽

Phase I And Ii

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Toxicity profiles of HER2/neupeptide anticancer vaccines: the picture from Phase/I and II clinical trials

Expert Review of Vaccines ◽

10.1586/erv.12.33 ◽

2012 ◽

Vol 11 (6) ◽

pp. 637-640 ◽

Cited By ~ 3

Author(s):

Constantin N Baxevanis ◽

Michael Papamichail ◽

Sonia A Perez

Keyword(s):

Clinical Trials ◽

Phase I ◽

Anticancer Vaccines ◽

Phase I And Ii

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Unconventional Anticancer Agents: A Systematic Review of Clinical Trials

Journal of Clinical Oncology ◽

10.1200/jco.2005.03.8406 ◽

2006 ◽

Vol 24 (1) ◽

pp. 136-140 ◽

Cited By ~ 20

Author(s):

Andrew J. Vickers ◽

Joyce Kuo ◽

Barrie R. Cassileth

Keyword(s):

Clinical Trials ◽

Phase I ◽

Cancer Patients ◽

Phase Ii ◽

Dose Finding ◽

Phase Iii ◽

High Dose ◽

Free Text ◽

Phase Ii Trials ◽

Off Label

Purpose A substantial number of cancer patients turn to treatments other than those recommended by mainstream oncologists in an effort to sustain tumor remission or halt the spread of cancer. These unconventional approaches include botanicals, high-dose nutritional supplementation, off-label pharmaceuticals, and animal products. The objective of this study was to review systematically the methodologies applied in clinical trials of unconventional treatments specifically for cancer. Methods MEDLINE 1966 to 2005 was searched using approximately 200 different medical subject heading terms (eg, alternative medicine) and free text words (eg, laetrile). We sought prospective clinical trials of unconventional treatments in cancer patients, excluding studies with only symptom control or nonclinical (eg, immune) end points. Trial data were extracted by two reviewers using a standardized protocol. Results We identified 14,735 articles, of which 214, describing 198 different clinical trials, were included. Twenty trials were phase I, three were phase I and II, 70 were phase II, and 105 were phase III. Approximately half of the trials investigated fungal products, 20% investigated other botanicals, 10% investigated vitamins and supplements, and 10% investigated off-label pharmaceuticals. Only eight of the phase I trials were dose-finding trials, and a mere 20% of phase II trials reported a statistical design. Of the 27 different agents tested in phase III, only one agent had a prior dose-finding trial, and only for three agents was the definitive study initiated after the publication of phase II data. Conclusion Unconventional cancer treatments have not been subject to appropriate early-phase trial development. Future research on unconventional therapies should involve dose-finding and phase II studies to determine the suitability of definitive trials.

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