A comparison of aerobic- and resistance-emphasised exercise on cardiometabolic health and quality of life in men receiving androgen deprivation therapy for prostate cancer: Protocol for a feasibility trial.

BACKGROUND: Those with intermediate and high-risk prostate cancer typically receive androgen deprivation therapy (ADT) as part of their treatment. ADT often results in extensive side effects including increased risk of cardiometabolic disease. Many ADT side effects can be influenced by exercise, both resistance and aerobic training. Exercise regimes typically combine aerobic and resistance exercise but the appropriate emphasis for achieving the broadest range of therapeutic benefits has yet to be determined. We propose to determine the feasibility of undertaking a larger trial comparing a resistance- vs an aerobic-emphasised exercise intervention in men with prostate cancer undergoing ADT. The trial will also investigate preliminary evidence of difference between arms for cardiometabolic health and quality of life outcomes. METHODS: This is a 6-month randomised two-armed feasibility trial. Prostate cancer patients undergoing ADT and radiotherapy will be recruited (n = 24) and randomised to either a resistance- or aerobic-emphasised group. Participants will attend twice-weekly supervised individual or small group sessions, with 75% of exercise time in the primary exercise modality. The primary outcome will be feasibility, determined via assessment of recruitment, retention, adherence, safety, and acceptability. Secondary outcomes will include quality of life, body composition, vascular indices, aerobic and muscular fitness and cardiometabolic health blood biomarkers. CONCLUSION: It is envisaged that the trial will provide valuable information and preliminary difference data that will aid in the design of an efficacious larger trial that will adopt a major and minor emphasis approach to the scheduling of resistance and aerobic exercise.

Designing effective exercise intervention trials for prostate cancer cohorts: a qualitative study on experiences and views of exercise oncology researchers.

BACKGROUND: Exercise intervention research has shown promising results in preventing and reversing the side effects caused by prostate cancer and its' treatment. However, there are still unanswered questions and the need for additional research. As the field of exercise oncology in the context of prostate cancer presents unique challenges and complexities, seeking the advice of experienced exercise oncology researchers before initiating a similar trial could help to design more effective and efficient studies and help avoid pitfalls. METHODS: A qualitative descriptive study design and a nonprobability, purposive sampling method was employed. An interview guide was developed and included topics such as recruitment, retention, programme goals, research design, health considerations, treatment considerations, adverse events, exercise prescription and outcome tools. Individual semi-structured interviews were conducted and interviews were transcribed and analysed using thematic analysis. RESULTS: Eight individuals with extensive experience working with prostate cancer patients in exercise oncology research settings were interviewed. Four main themes and seven subthemes were generated and supported by the data. Theme 1 highlighted the critical role of recruitment, with associated subthemes on recruitment barriers and recruitment methods. Theme 2 explored the positives and negatives of home-based programmes. Theme 3 focused on specific health characteristics, exercise prescription and outcome measure factors that must be considered when working with prostate cancer cohorts. Finally, theme 4 centered around the emotional dimensions present in exercise oncology trials, relating to both researchers and study participants. CONCLUSION: Exercise oncology remains a challenging area in which to conduct research. Learning from experienced personnel in the field offers valuable information and guidance that could impact the success of future trials.

Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression.

BACKGROUND: The optimal EBRT schedule for MSCC is undetermined. Our aim was to determine whether a single fraction (SF) was non-inferior to five daily fractions (5Fx), for functional motor outcome. METHODS: Patients not proceeding with surgical decompression in this multicentre non-inferiority, Phase 3 trial were randomised to 10 Gy/SF or 20 Gy/5Fx. A change in mobility from baseline to 5 weeks for each patient, was evaluated by a Modified Tomita score: 1 = 'Walk unaided', 2 = 'With walking aid' and 3 = 'Bed-bound'. The margin used to establish non-inferiority was a detrimental change of -0.4 in the mean difference between arms. RESULTS: One-hundred and twelve eligible patients were enrolled. Seventy-three patients aged 30-87 were evaluated for the primary analysis. The 95% CI for the difference in the mean change in mobility scores between arms was -0.12 to 0.6. Since -0.4 is not included in the interval, there is evidence that 10 Gy/SF is non-inferior to 20 Gy/5Fx. One grade 3 AE was reported in the 5Fx arm. Twelve (26%) patients in the 5Fx arm had a Grade 2-3 AE compared with six (11%) patients in the SF arm (p = 0.093). CONCLUSION: For mobility preservation, one 10-Gy fraction is non-inferior to 20 Gy in five fractions, in patients with MSCC not proceeding with surgical decompression. CLINICAL TRIAL REGISTRATION: Cancer Trials Ireland ICORG 05-03; NCT00968643; EU-20952.

Durable treatment response of relapsing CNS plasmacytoma using intrathecal chemotherapy, radiotherapy, and Daratumumab.

CNS myelomatous involvement is a rare complication of multiple myeloma with dismal outcome. This disease's optimal treatment is unclear. Combined approach of systemic therapy, radiotherapy, and intrathecal injections chemotherapy should be considered and autologous stem cell transplant consolidation is offered to eligible patients. The role of Daratumumab in this disease deserves further evaluation.

Cancer Trials Ireland (ICORG) 06-34: A multi-centre clinical trial using three-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer.

TITLE: Cancer Trials Ireland (ICORG) 06-34: A multi-centre clinical trial using three-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer. NCT01176487. BACKGROUND & PURPOSE: Trials of radiation therapy for the palliation of intra-thoracic symptoms from locally advanced non-small cell lung cancer (NSCLC) have concentrated on optimising fractionation and dose schedules. In these trials, the rates of oesophagitis induced by this "palliative" therapy have been unacceptably high. In contrast, this non-randomised, single-arm trial was designed to assess if more technically advanced treatment techniques would result in equivalent symptom relief and reduce the side-effect of symptomatic oesophagitis. MATERIALS & METHODS: Thirty-five evaluable patients with symptomatic locally advanced or metastatic NSCLC were treated using a three-dimensional conformal technique (3-DCRT) and standardised dose regimens of 39 Gy in 13 fractions, 20 Gy in 5 fractions or 17 Gy in 2 fractions. Treatment plans sought to minimise oesophageal dose. Oesophagitis was recorded during treatment, at two weeks, one month and three months following radiation therapy and 3-6 monthly thereafter. Mean dose to the irradiated oesophagus was calculated for all treatment plans. RESULTS: Five patients (14%) had experienced grade 2 oesophagitis or dysphagia or both during treatment and 2 other patients had these side effects at the 2-week follow-up. At follow-up of one month after therapy, there was no grade two or higher oesophagitis or dysphagia reported. 22 patients were eligible for assessment of late toxicity. Five of these patients reported oesophagitis or dysphagia (one had grade 3 dysphagia, two had grade 2 oesophagitis, one of whom also had grade 2 dysphagia). Quality of Life (QoL) data at baseline and at 1-month follow up were available for 20 patients. At 1-month post radiation therapy, these patients had slightly less trouble taking a short walk, less shortness of breath, did not feel as weak, had better appetite and generally had a better overall quality of life than they did at baseline. They did report being slightly more tired. CONCLUSIONS: This trial is the first of its kind showing that 3-DCRT provides patients with lower rates of oesophageal toxicity whilst yielding acceptable rates of symptom control. (Sponsored by Cancer Trials Ireland (ICORG) Study number 06-34, the Friends of St. Luke's and the St. Luke's Institute of Cancer Research.).