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Supplementation of omega-3 (n-3) polyunsaturated fatty acids has been associated with reduced side effects and improved quality of life (QoL) in breast cancer patients receiving chemotherapy. The current study reports secondary outcomes from the DHA WIN randomized controlled trial which was designed to evaluate docosahexaenoic acid (DHA) supplementation (4.4 g/day) in conjunction with six cycles of neoadjuvant chemotherapy (NAC) (3 weeks/cycle) in women with non-metastatic breast cancer (n = 49). The objective of the current study was to assess the effects of DHA supplementation on QoL and exercise behaviour in women undergoing NAC for breast cancer. Self-administered questionnaires were used to measure QoL and exercise behaviour before starting chemotherapy (baseline), before each chemotherapy cycle (exercise), and after completing chemotherapy. DHA supplementation did not significantly affect QoL, aerobic exercise volume or resistance training frequency during treatment. However, mean aerobic exercise volume was significantly lower at week 12 (-53.5 minutes/week; 95% CI, -100.5 to -6.3; p = 0.02) and week 18 (-70.8 minutes/week; 95% CI, -123.0 to -18.6; p = 0.01) compared to baseline. Mean resistance training frequency was lower at week 12 (-0.57 times/week; 95% CI, -1.0 to -0.13; p = 0.02) compared to baseline. Meeting exercise guidelines during chemotherapy was not associated with better QoL. In the current exploratory study, QoL and exercise decreased during treatment regardless of DHA supplementation, highlighting the need for supportive care and potential therapies that may mitigate these declines in breast cancer patients receiving NAC. Adequately powered studies are needed to determine if DHA supplementation improves these two indices of health. The trial is registered at ClinicalTrials.gov (NCT03831178).

The use of exercise testing as an objective assessment of cardiorespiratory fitness in clinical oncology research has increased substantially over the past decade. However, its quality has not been assessed. We did a systematic review of studies of formal exercise testing for adults with cancer. Studies were assessed according to the American Thoracic Society/American College of Chest Physicians (ATS/ACCP) recommendations for exercise testing. Overall, the reporting of exercise-testing methods and data for adults with cancer suggests that the conduct of these tests does not comply with national and international quality guidelines. We give recommendations for exercise testing in clinical oncology research. The adoption of consistent, formal standards for methods and data reporting in exercise testing is needed to ensure high-quality research in clinical oncology. Overall, we present information for clinicians and exercise-oncology researchers who assess and care for patients with cancer.

One of the main reasons for disease recurrence in the curative breast cancer treatment setting is the development of drug resistance. Microtubule targeted agents (MTAs) are among the most commonly used drugs for the treatment of breaset cancer and therefore overcoming taxane resistance is of primary clinical importance. Our group has previously demonstrated that the microtubule dynamics of docetaxel-resistant MCF-7TXT cells are insensitivity to docetaxel due to the distinct expression profiles of β-tubulin isotypes in addition to the high expression of p-glycoprotein (ABCB1). In the present investigation we examined whether taxane-resistant breast cancer cells are more sensitive to microtubule destabilizing agents including vinca alkaloids and colchicine-site binding agents (CSBAs) than the non-resistant cells. Two isogenic MCF-7 breast cancer cell lines were selected for resistance to docetaxel (MCF-7TXT) and the wild type parental cell line (MCF-7CC) to examine if taxane-resistant breast cancer cells are sensitive to microtubule-destabilizing agents including vinca alkaloids and CSBAs. Cytotoxicity assays, immunoblotting, indirect immunofluorescence and live imaging were used to study drug resistance, apoptosis, mitotic arrest, microtubule formation, and microtubule dynamics. MCF-7TXT cells were demonstrated to be cross resistant to vinca alkaloids, but were more sensitive to treatment with colchicine compared to parental non-resistant MCF-7CC cells. Cytotoxicity assays indicated that the IC50 of MCF-7TXT cell to vinorelbine and vinblastine was more than 6 and 3 times higher, respectively, than that of MCF-7CC cells. By contrast, the IC50 of MCF-7TXT cell for colchincine was 4 times lower than that of MCF-7CC cells. Indirect immunofluorescence showed that all MTAs induced the disorganization of microtubules and the chromatin morphology and interestingly each with a unique pattern. In terms of microtubule and chromain morphology, MCF-7TXT cells were more resistant to vinorelbine and vinblastine, but more sensitive to colchicine compared to MCF-7CC cells. PARP cleavage assay further demonstrated that all of the MTAs induced apoptosis of the MCF-7 cells. However, again, MCF-7TXT cells were more resistant to vinorelbine and vinblastine, and more sensitive to colchicine compared to MCF-7CC cells. Live imaging demonstrated that the microtubule dynamics of MCF-7TXT cells were less sensitive to vinca alkaloids, and more sensitive to colchicine. MCF-7TXT cells were also noted to be more sensitive to other CSBAs including 2MeOE2, ABT-751 and phosphorylated combretastatin A-4 (CA-4P). Docetaxel-resistant MCF-7TXT cells have demonstrated cross-resistance to vinca alkaloids, but appear to be more sensitive to CSBAs (colchicine, 2MeOE2, ABT-751 and CA-4P) compared to non-resistant MCF-7CC cells. Taken together these results suggest that CSBAs should be evaluated further in the treatment of taxane resistant breast cancer.

Background An underlying cause of solid tumor resistance to chemotherapy treatment is diminished tumor blood supply, which leads to a hypoxic microenvironment, dependence on anaerobic energy metabolism, and impaired delivery of intravenous treatments. Preclinical data suggest that dietary strategies of caloric restriction and low-carbohydrate intake can inhibit glycolysis, while acute exercise can transiently enhance blood flow to the tumor and reduce hypoxia. The Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer (DREAM) study will compare the effects of a short-term, 50% calorie-restricted and ketogenic diet combined with aerobic exercise performed during intravenous chemotherapy treatment to usual care on changes in tumor burden, treatment side effects, and quality of life. Methods Fifty patients with measurable metastases and primary breast cancer starting a new line of intravenous chemotherapy will be randomly assigned to usual care or the combined diet and exercise intervention. Participants assigned to the intervention group will be provided with food consisting of 50% of measured calorie needs with 80% of calories from fat and ≤ 10% from carbohydrates for 48–72 h prior to each chemotherapy treatment and will perform 30–60 min of moderate-intensity cycle ergometer exercise during each chemotherapy infusion, for up to six treatment cycles. The diet and exercise durations will be adapted for each chemotherapy protocol. Tumor burden will be assessed by change in target lesion size using axial computed tomography (primary outcome) and magnetic resonance imaging (MRI)-derived apparent diffusion coefficient (secondary outcome) after up to six treatments. Tertiary outcomes will include quantitative MRI markers of treatment toxicity to the heart, thigh skeletal muscle, and liver, and patient-reported symptoms and quality of life. Exploratory outcome measures include progression-free and overall survival. Discussion The DREAM study will test a novel, short-term diet and exercise intervention that is targeted to mechanisms of tumor resistance to chemotherapy. A reduction in lesion size is likely to translate to improved cancer outcomes including disease progression and overall survival. Furthermore, a lifestyle intervention may empower patients with metastatic breast cancer by actively engaging them to play a key role in their treatment. Trial registration ClinicalTrials.gov, NCT03795493 , registered 7 January, 2019.

In-person nutrition and exercise interventions improve physical function in chronic diseases, yet the acceptability and effectiveness of web-based delivery, especially with different levels of personnel support, require further investigation. This study aims to evaluate a web-based nutrition and exercise intervention delivered entirely digitally from recruitment to trial completion. A randomized controlled trial was conducted using the Heal-Me version 1 platform across 2 levels of personnel support (Light and Intensive). Eligible adults with a history of cancer, chronic lung disease, or liver or lung transplant; internet access; and prior participation in a rehabilitation program were enrolled in a fully web-based program to minimize barriers to exercise participation. Participants were randomly assigned (1:1:1) to 1 of 3 study groups. The control group received a detailed, self-directed digital nutrition and exercise guide. The Heal-Me Light group received the web-based intervention alongside dietitian and exercise specialist-led group classes. The Heal-Me Intensive group received web-based intervention, group classes, and one-to-one sessions with the dietitians and exercise specialists. All participants received a wearable activity tracker. The primary acceptability outcome was adherence to the intervention based on a priori targets. The primary effectiveness outcome was the change in Lower Extremity Functional Scale (LEFS) score. Secondary outcomes included physical function tests, which were performed and measured by videoconference. Questionnaires were used to assess well-being, quality of life, and food intake. Analyses adhered to the intention-to-treat principle. Of 216 participants, 202 (93.5%) completed the intervention (mean 61, SD 11 years; female: 130/202, 64.4%; cancer: 126/202, 62.4%). Adherence exceeded a priori targets, with 82% (105/128) attending >75% of the program elements including postintervention tests. Participants rated the program as \"quite a bit\" or \"very\" useful, with similar ratings between Heal-Me Light (56/64, 88%) and Heal-Me Intensive (51/58, 88%) groups (P=.69). No significant differences were found for changes in LEFS scores (control: mean 0.8, SD 7.7; Heal-Me: mean 0.3, SD 6.6; P=.53). Significant benefits were found in favor of the combined Heal-Me intervention groups versus controls for change in the 2-minute step test, World Health Organization-5 Well-Being Index, Short-Form-36 general, physical health role, energy or fatigue scales, and protein intake. While the change in physical function was similar between the 2 intervention arms, the more intensive one-to-one interaction (Heal-Me Intensive) led to greater improvements in perceived nutrition self-management. No serious adverse events occurred. The demonstrated satisfaction, adherence, and effectiveness highlight the high acceptability of a web-based, semisupervised nutrition and exercise intervention delivered entirely digitally in individuals with chronic disease. Future studies may benefit from having a baseline physical function inclusion threshold, the use of a more sensitive primary physical function measure, and a higher intensity digital exercise intervention in exercise-experienced participants. Clinicaltrials.gov NCT04666558; https://clinicaltrials.gov/study/NCT04666558. RR2-10.1016/j.cct.2022.106791.

Background With advances in cancer diagnosis and treatment, women with early-stage breast cancer (ESBC) are living longer, increasing the number of patients receiving post-treatment follow-up care. Best-practice survivorship models recommend transitioning ESBC patients from oncology-provider (OP) care to community-based care. While developing materials for a future randomized controlled trial (RCT) to test the feasibility of a nurse-led Telephone Survivorship Clinic (TSC) for a smooth transition of ESBC survivors to follow-up care, we explored patients’ and OPs’ reactions to several of our proposed methods. Methods We used a qualitative study design with thematic analysis and a two-pronged approach. We interviewed OPs, seeking feedback on ways to recruit their ESBC patients for the trial, and ESBC patients, seeking input on a questionnaire package assessing outcomes and processes in the trial. Results OPs identified facilitators and barriers and offered suggestions for study design and recruitment process improvement. Facilitators included the novelty and utility of the study and simplicity of methods; barriers included lack of coordination between treating and discharging clinicians, time constraints, language barriers, motivation, and using a paper-based referral letter. OPs suggested using a combination of electronic and paper referral letters and supporting clinicians to help with recruitment. Patient advisors reported satisfaction with the content and length of the assessment package. However, they questioned the relevance of some questions (childhood trauma) while adding questions about trust in physicians and proximity to primary-care providers. Conclusions OPs and patient advisors rated our methods for the proposed trial highly for their simplicity and relevance then suggested changes. These findings document processes that could be effective for cancer-patient recruitment in survivorship clinical trials.

ImportanceSystemic chemotherapy can be administered either through a peripheral vein (IV), or centrally through peripherally inserted central catheter (PICC), totally implanted vascular access devices (PORTs) or tunnelled cuffed catheters. Despite the widespread use of systemic chemotherapy in patients with breast cancer, the optimal choice of vascular access is unknown.ObjectiveThis systematic review evaluated complication rates and patient satisfaction with different access strategies for administering neo/adjuvant chemotherapy for breast cancer.Evidence reviewedOvid Medline, EMBASE and the Cochrane Central Register of Controlled Trials were searched from 1946 to September 2017. Two reviewers independently assessed each citation. The Newcastle–Ottawa scale was used to assess the quality of cohort and case–control studies.FindingsOf 1584 citations identified, 15 unique studies met the pre-specified eligibility criteria. There were no randomised studies comparing types of vascular access. Reports included six single-institution retrospective cohort studies, one retrospective multi-institution cohort, one retrospective cohort database study, five prospective single-institution studies, one prospective multi-institution study and one nested case–control study. Median complication rates were infection: 6.0% PICC (2 studies) versus 2.1% PORT (8 studies); thrombosis: 8.9% PICC (2 studies) versus 2.6% PORT (9 studies); extravasation: 0 PICC (1 study) versus 0.4% PORT (4 studies) and mechanical issues: PICC 3.8% (1 study) versus 1.8% PORT (9 studies). Satisfaction/quality of life appeared high with each device.ConclusionIn the absence of high-quality data comparing vascular access strategies, randomised, adequately powered, prospective studies would be required to help inform clinical practice and reduce variation.

Purpose The neoadjuvant treatment of breast cancer (NABC) is a rapidly changing area that benefits from guidelines integrating evidence with expert consensus to help direct practice. This can optimize patient outcomes by ensuring the appropriate use of evolving neoadjuvant principles. Methods An expert panel formulated evidence-based practice recommendations spanning the entire neoadjuvant breast cancer treatment journey. These were sent for practice-based consensus across Canada using the modified Delphi methodology, through a secure online survey. Final recommendations were graded using the GRADE criteria for guidelines. The evidence was reviewed over the course of guideline development to ensure recommendations remained aligned with current relevant data. Results Response rate to the online survey was almost 30%; representation was achieved from various medical specialties from both community and academic centres in various Canadian provinces. Two rounds of consensus were required to achieve 80% or higher consensus on 59 final statements. Five additional statements were added to reflect updated evidence but not sent for consensus. Conclusions Key highlights of this comprehensive Canadian guideline on NABC include the use of neoadjuvant therapy for early stage triple negative and HER2 positive breast cancer, with subsequent adjuvant treatments for patients with residual disease. The use of molecular signatures, other targeted adjuvant therapies, and optimal response-based local regional management remain actively evolving areas. Many statements had evolving or limited data but still achieved high consensus, demonstrating the utility of such a guideline in helping to unify practice while further evidence evolves in this important area of breast cancer management.

PurposeAll vascular access strategies foradministering chemotherapy in early stage breast cancer (EBC) are associated with risks and benefits. As the most effective type of access is unknown a feasibility trial, prior to conducting a large pragmatic trial, was undertaken.MethodsThe trial methodology utilized broad eligibility criteria and the integrated consent model incorporating oral consent. EBC patients receiving non-trastuzumab-containing chemotherapy were randomized to peripheral access or central line insertion. The a priori definition of feasibility was: > 25% of patients approached agreed to randomisation and > 25% of physicians approached patients. Secondary outcomes included rates of line-associated complications.ResultsOf 159 patients approached, 150 (94.3%) agreed to randomisation, 77 (51.3%) were randomized to peripheral and 73 (48.7%) to central access. 6/26 (23.1%) of medical oncologists approached patients. Rates of complications per chemotherapy cycles in the peripheral vs central access groups with risk difference (RD) (95% CI) were: thrombotic events requiring anticoagulation [1 (0.3%) vs. 3 (1.0%), RD − 0.7(− 1.9,0.5)], line infections [0 (0%) vs. 1 (0.3%), RD − 0.3(− 0.9,0.3)], phlebitis [2 (0.6%) vs. 0 (0%), RD 0.3(− 0.3,0.8)], and tissue infiltrations [4 (1.1%) vs. 1 (0.3%), RD 0.8(− 0.4,2.1)]. Overall, 8.0% (6/75) and 7.7% (5/65) of patients had at least one of these complications in the peripheral and central access arms respectively [RD − 0.9(− 9.4,7.6)]. The study was terminated early due to slow accrual.ConclusionWhile meeting its a priori feasibility criteria for patient engagement, the slow accrual means that conducting a large pragmatic trial would require overcoming the barriers to physician recruitment.TRIAL REGISTRATION: NCT02688998

Background: Our aim was to understand cancer survivor needs prior to, and following the Alberta Cancer Exercise (ACE) pilot randomized trial as a means to inform implementation of a province-wide cancer-specific, community-based exercise program. Methods: Questionnaires and semi-structured stakeholder engagement sessions were conducted with cancer survivors to explore preferences, barriers and facilitators/benefits at two timepoints: (1) pre-ACE: prior to initiation of the ACE pilot trial (n = 13 survivors and n = 5 caregivers); and (2) post-ACE: following participation in the ACE pilot trial (n = 20 survivors). Descriptive statistics were used to summarize quantitative data from questionnaires. Stakeholder engagement data were analyzed using a framework analysis approach. Emergent themes were then mapped to actionable outcomes. Results: Pre-ACE, survivors indicated a preference for exercise programs that were (1) supervised by exercise specialists knowledgeable about cancer, (2) included support from other health care providers, (3) were held in community locations that were easily accessible. Post-ACE, participants identified (1) a lack of exercise counseling from health care providers, (2) the need for earlier introduction of exercise in the care pathway, and (3) supported referral to exercise programming. Conclusions: An integrated knowledge translation approach identified actionable outcomes to address survivor needs related to exercise in clinical cancer and community-based contexts.