Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Metabolic Syndrome

Syndrome

Metabolic Diseases

Autonomic Nervous System Diseases

Primary Dysautonomias

Lipid Metabolism Disorders

Insulin Resistance

Hyperinsulinism

Glucose Metabolism Disorders

Menopause

Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence. Each of the groups will be split into two different exercise programmes. Both programmes, High Intensity Interval Training (HIIT) programme (metabolic power training) and Muscle Power Intervention (MPI) programme will consist of 8 weeks.

Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence.

Metabolic Power Training: A High Intensity Interval Training (HIIT) intervention, 3 times per week (30 min session) during 8 weeks with professional supervision and intensities adapted and modified during the intervention period.

HIIT program (8 weeks)

Muscle Power Intervention (MPI), 2 times per week (45 min session) during 8 weeks with professional supervision and intensities adapted and modified during the intervention period.

MPI program (8 weeks)

Cristina Blasco Lafarga, Tenured Professor

Cristina Blasco Lafarga, PhD

Jordi Monferrer-Marín, Predoctoral student

Ainoa Roldán, PhD

Jørn Wulff Helge, PhD

POWER Health is a randomized clinical trial with a two-arm parallel design whose objectives are 1) to study metabolic flexibility and autonomic function (both capacities that describe cardiovascular health) in a sample of postmenopausal oncological women vs postmenopausal untreated controls (CT); and 2) to analyze the impact of two different 8-week physical exercise supervised interventions: HIIT training vs strength training focused on muscle power, on both cardiovascular capacities in these populations.

Nowadays, breast cancer is the most common type of cancer worldwide, accounting for 30% of all cancers in Spanish women in 2023. Cancer is also the second leading cause of death in developed countries, following cardiovascular diseases, with which it shares a close relationship. Additionally, we know that the incidence of breast cancer increases with age, experiencing a rise after menopause. However, lifestyle and physical exercise are known to improve the prevention, prognosis, and survival of this disease, as well as enhance quality of life in these patients. Indeed, recent studies have highlighted the relevance of cardiovascular health in this oncological process, as well as the potential of physical exercise interventions to improve cardiovascular health following the disease.

POWER Health is a randomized clinical trial aimed at studying metabolic flexibility and autonomic health in a population of breast cancer recurrence-free women (RFC) compared to postmenopausal untreated controls (CT), along with the implementation of two supervised exercise interventions in both populations. These interventions will last for 8 weeks, one involving HIIT exercise focused on improving metabolic power (MPI), and the other one involving strength exercise focused on enhancing muscular power, with the hypothesis of better metabolic flexibility and autonomic function, and consequently, better cardiovascular health.

POWER health is a mixed method design: cross-sectional \& longitudinal study. Given the feasibility and simple application of POWER Health, this clinical trial will contribute to the prevention and improvement of the health of postmenopausal women, with an important clinical and economic impact, not only in the scientific community but also in clinical practice.

Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study

Postmenopausal Oncological Women Exercising for Recover Their Health. Associations and Changes in Metabolic Flexibility and Autonomic Control After Two Training Programs (Muscle Power vs Metabolic Power): the POWER Health Study

Fat oxidation rates calculated from VO2 and VCO2 values collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) and after applying Frayn's stoichiometric formulae, during an incremental test from 0.45 W/kg with 0.15W/kg each 4-min step

Non-linear mathematical variable that allows collecting physiological information and vagal activity of the organism, analysed in 2-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test

Calf, waist and hip circumferences will be assessed with an anthropometric tape measure (cm)

Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)

The investigators will also assess systolic and diastolic blood pressure in the left (whenever possible) arm at rest.

The investigators will also assess oxygen saturation in middle finger of the right hand at rest.

The SARC-F will be used to evaluate the risk of sarcopenia

The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. Minimum value = 0 min/day of physical activity // Maximum value = 1440 min/day of physical activity. Higher scores imply a more physically active pattern.

Lactate assessment will be obtained by lactate analyzer (Lactate Scout Sport SensLab GmbH, Leipzig, Germany)

The Rating Perceived Exertion (RPE) of Borg scale will be used to obtain the perceived effort. Minimum value: 1 // Maximum value: 10. Higher scores mean a worse outcome.

The Visual Analogue Scale of Pain (VAS) scale will be used to obtain the local pain assessment. Minimum value: 1 // Maximum value: 10. Higher scores mean a worse outcome.

Cadence will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).

Power will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).

Power will be calculated by Power Frail App (Toledo, Spain)

Metabolic rate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

Resting exchange ratio will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

Fat oxidation will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

Carbohydrate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

Carbohydrate oxidation rates will be calculated from VO2 and VCO2 values collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) and after applying Frayn's stoichiometric formulae, during an incremental test from 0.45 W/kg with 0.15W/kg each 4-min step

Energy expenditure rate will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test

FATmax will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test

VO2peak will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test

Non-linear mathematical variable that allows collecting physiological information and parasympathetic activity of the organism, analysed in 3-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test

Linear mathematical variable that allows collecting physiological information and parasympathetic activity of the organism, analysed in 2-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test

Generalitat Valenciana

University of Valencia

Senior Lecturer

Digestive System Diseases

Obesity

Adenoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Participants recruited to the healthy arm of the BORICC Study (BORICC1) at baseline.

Participants recruited to the polyp arm of the BORICC Study (BORICC2) at baseline, with a prior history of polyps.

John Mathers

Worldwide, colorectal cancer is the 3rd most common cancer; risk increases with age and is modified by lifestyle factors notably diet, physical activity and obesity. The BORICC Follow-Up (BFU) Study is a 12+ year follow-up of participants recruited to the Biomarkers of Risk of Colon Cancer (BORICC) Study. This longitudinal study will investigate associations between ageing and lifestyle factors and a panel of molecular biomarkers linked with colorectal cancer risk.

The BORICC Follow-Up (BFU) Study builds on the findings from the BORICC Study where the investigators observed associations between age and nutritional factors, including selenium and folate, and biomarkers of colorectal health.

The BFU Study will investigate the relationships between ageing (12+ years) and such biomarkers longitudinally. It is anticipated that the project will produce novel data on (i) changes in biomarkers of colorectal cancer risk with age and (ii) the effects of obesity and lifestyle factors on biomarkers of colorectal cancer risk. These biomarkers include differentially expressed proteins, DNA methylation markers and inflammation markers.

The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study

Measured using Tanita Bioimpedance scales

Abundance and diversity of the gut microbiota assessed in stool samples

Concentrations and proportions of short-chain fatty acids e.g. acetate, propionate and butyrate

Target gene and global methylation (LINE-1) in rectal mucosal biopsies

Expression of genes related to inflammation and the WNT signalling pathway in rectal mucosal biopsies

Expression of microRNAs in rectal mucosal biopsies

Total number and distribution of proliferating cells in rectal mucosal crypts

Height (length) and width rectal mucosal crypts

Markers of mitochondrial function and structure in rectal mucosal biopsies such as oxidative phosphorylation proteins, namely complex I and IV

Northumbria Healthcare NHS Foundation Trust

Newcastle University

Frailty

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

This is a multi-centre prospective non-interventional study designed to evaluate the effects of patient age on the pharmacokinetics of capecitabine and its metabolites 5'DFCR, 5'DFUR, and 5-FU. In addition, the study will assess the correlation between the pharmacokinetic parameters calculated and cytidine deaminase, biomarkers of aging, clinical frailty, treatment outcome, and toxicity. To be enrolled, patients must have breast or colorectal cancer and be eligible to receive capecitabine monotherapy in accordance with its approved clinical usage in the UK. Treatment will be administered according to NICE guidelines as well as the clinical judgement of the prescribing physician. One hundred patients (50 breast cancer patients, 50 colorectal cancer patients) who are about to start treatment with capecitabine monotherapy will be recruited to the study and undergo study procedures within the first week of treatment.

Association of Capecitabine Pharmacokinetics and Toxicity With Aging

A Prospective Evaluation of Capecitabine and Metabolite Pharmacokinetics in Elderly Breast and Colorectal Cancer Patients and Their Association With Toxicity and Molecular Markers of Enzyme Activity and Aging

Measurement of AUC of capecitabine and its metabolites 5'deoxy-5-fluorocytidine (5'DFCR), 5'deoxy-5-fluorouridine (5'DFUR), and 5-fluorouracil.

Toxicity grade(s) as measured by CTCAE version 4.03 (published by the U.S. Department of Heath and Human Services 2009). General grading scheme is as follows: Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

Progression free survival as measured by the RECIST criteria version 1.1 (Eisenhauer et al., 2009). The RECIST criteria define progression as 'at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression)'

Complete or partial response as measured by the RECIST criteria version 1.1. (Eisenhauer et al., 2009) Complete response = 'Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Partial response = 'At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'

Grip strength measured in kg by the grip strength test (using the Takei handheld dynamometer)

Frailty as measured by the Edmonton Frail Scale. A 17 point scale that measures 9 frailty domains. 0-5: not frail; 6-7: vulnerable; 8-9: mild frailty; 10-11: moderate frailty; 12-17: severe frailty.

Nutritional status as measured by the Mini Nutritional Assessment questionnaire, a 30 point test on nutritional status. Scoring: 24 to 30 points: Normal nutritional status.

17 to 23.5 points: At risk of malnutrition. Less than 17 points: malnourished.

Quality of life as measured by the EORTC-QLQ-C30 version 3 questionnaire. This questionnaire assesses the quality of life of cancer patients in a series of 30 questions, with 28 of the questions on a scale of 1 to 4 where 1 is 'not at all' and 4 is 'very much'. Final two questions relate to overall quality of life and health on a scale of 1 to 7, where 1 is 'very poor' and 7 is 'excellent'.

Plasma cytidine deaminase activity (measured in units/mg protein by spectrophotometric assay).

Cmax of capecitabine and its metabolites 5'deoxy-5-fluorocytidine (5'DFCR), 5'deoxy-5-fluorouridine (5'DFUR), and 5-fluorouracil.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study	NCT06336070	Breast Cancer F... Cardiometabolic... Metabolism Diso... Autonomic Dysfu... Cardiovascular ...	HIIT program (8... MPI program (8 ...	35 Years - 75 Years	University of Valencia
Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study	NCT06336070	Breast Cancer F... Cardiometabolic... Metabolism Diso... Autonomic Dysfu... Cardiovascular ...	HIIT program (8... MPI program (8 ...	35 Years - 75 Years	University of Valencia
The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study	NCT04005742	Colorectal Canc...		-	Newcastle University
Association of Capecitabine Pharmacokinetics and Toxicity With Aging	NCT03465202	Breast Cancer Colorectal Canc...	Capecitabine	18 Years -	Newcastle-upon-Tyne Hospitals NHS Trust
The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study	NCT04005742	Colorectal Canc...		-	Newcastle University

Spots Global Cancer Trial Database for ageing

Every month we try and update this database with for ageing cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ageing

Every month we try and update this database with for ageing cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ageing cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.