Neoplasms

All Conditions

Head and Neck Neoplasms

Exercise and nutrition during radiotherapy: Physical exercise, nutritional advice and oral nutritional supplements.

Multidimensional rehabilitation after radiotherapy: Physical exercise, nutritional advice, oral nutritional supplements and patient education

The intervention consists of physical exercise, nutritional counselling and supplements. The exercise sessions will be conducted twice a week for 30 minutes each time during the RT treatment period, and include a main part of progressive resistance training (PRT). The PRT will be conducted by conventional upper and lower body exercises at a load of 60 - 80 % of 1 repetition maximum (RM) in 3-4 sets of 6-12 repetitions. The patients will receive nutritional information and dietary advice, and up to 2 energy dense oral nutritional supplements (ONS) daily. A nutrition interview will be conducted at study baseline and individual goals and targets will be set during the first counselling and monitored during the intervention period.

Exercise and nutrition during radiotherapy

The intervention consists of physical exercise, nutritional counselling and supplements and patient education. The exercise sessions will be conducted 3 times a week for 45 minutes each time during the 3 week rehabilitation programme, and include a main part of progressive resistance training (PRT). PRT will be conducted as described in the intervention during treatment. The nutritional intervention will be carried out as described in the intervention during treatment. Patient education will be run as 45-60 minutes lecture/group discussion on relevant topics, lead by health professionals.

Multidimensional rehabilitation after radiotherapy

Jo-Åsmund Lund, MD PhD

Stein Kaasa, prof MD

Patients treated for head and neck cancer (HNC) suffer from severe side-effects such as pain and difficulties in swallowing, often leading to weight loss. More than 70 % of the weight loss is attributed to lean muscle wasting that is associated with decline in physical function, substantial fatigue and significantly decreased quality of life. Rehabilitation that includes physical exercise, nutritional counselling and oral nutritional supplements (ONS) can potentially reduce or prevent muscle wasting. The primary aim of this pilot randomised trial is to assess feasibility, evaluate patient experiences and assess preliminary effects on muscle mass, physical function, nutritional status and quality of life of rehabilitation interventions during and after radiotherapy (RT). Newly diagnosed HNC patients referred for curative RT with or without chemotherapy, will be randomised to a) rehabilitation during RT or b) rehabilitation after RT. Rehabilitation during RT will be carried out at an outpatient facility during the treatment period (6-7 weeks) and rehabilitation after RT will be carried at a rehabilitation centre and last for 3 weeks.

Rehabilitation for Head and Neck Cancer

Rehabilitation During Versus After Radiotherapy in Head and Neck Cancer - a Pilot Randomised Controlled Trial

St. Olavs Hospital

LHL-Klinikkene, Røros

Oslo University Hospital

Norwegian University of Science and Technology

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Wasting Syndrome

Cachexia

Syndrome

Body Weight

Weight Loss

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Anti-Inflammatory Agents

All Drugs and Chemicals

Antirheumatic Agents

Analgesics

Celecoxib

Nutritional supplements aimed at optimal energy balance and protein intake (2 cartons of ProSure per day), nutritional advice, home-based self-assisted exercise program and anti-inflammatory treatment (300 mg celecoxib) for 6 weeks. The aerobic exercise program is performed as self-administered daily walking sessions, aiming for a minimum of two sessions 30 minutes on a weekly basis. Other aerobic activities could be used instead of walking. The resistance exercise program should be performed 3 times weekly and lasts about 20 minutes. The program is targeting major muscle groups in the upper body and legs with use of weights. The intensity of the exercise and performance of the exercises are adapted to the individual patient's disease burden and physical performance.

Multimodal intervention

Standard care

Stein Kaasa, MD, PhD

Ken Fearon, MD, PhD

A multicentre, open, randomized phase II study comparing a multimodal intervention (oral nutritional supplements, celecoxib and physical exercise) for cachexia versus standard cancer care.

A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study

The aim of this study is to investigate the feasibility of the multimodal intervention for cancer cachexia by assessing; enrolment rate, compliance with study intervention, contamination-rate in the control group with respect to any of the interventions.

University of Edinburgh

NHS Greater Glasgow and Clyde

Copenhagen University Hospital at Herlev

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Prostatic Neoplasms

Atrial Fibrillation

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Arrhythmias, Cardiac

Heart Diseases

Other Dietary Supplements

Omega 3 Fatty Acid

ALA-rich diet

David JA Jenkins

The problem is the lack of data from randomized controlled trials to throw light on the ALA-prostate cancer issue. There is therefore a need to acquire evidence from a randomized controlled study to illustrate the effect of ALA on a surrogate marker for prostate cancer, namely prostate specific antigen (PSA). Demonstration that atrial fibrillation recurrence was reduced after cardioversion and that there was no adverse effect of 1 years of ALA feeding on PSA would go a considerable way to providing the required evidence that ALA in the human diet has no adverse effect on the prostate and so allow its use for cardiovascular risk reduction. hypothesis: The effect of ALA on PSA levels over time will be no different from the control, so providing supportive data for the view that ALA is not cancer promoting.

In addition disturbing news on alpha-linolenic acid (ALA) has recently been reviewed by Brouwer and colleagues (J Nutr:2004). Their analyses suggests that ALA, as found in canola oil and other healthy foods, may cause prostate cancer even though there is good evidence that canola oil will prevent heart disease. This issue urgently needs further research.

In studies largely from the Harvard group, but suggested by additional studies from Uruguay and Spain, a link has been identified between ALA intake and prostate cancer. The Harvard studies are cohort studies where groups of approximately 40,000 doctors or health professionals have been followed up for periods of 10 years and the dietary intakes of ALA related to the subsequent development of aggressive prostate cancer. It must be stressed that these are not randomized crossover studies which are the currently accepted gold standard for evidence-based medicine and regulatory decision making. Nevertheless they raise concern over the health profile of a fatty acid with a growing reputation for cardiovascular disease prevention and a component of other healthy foods such as walnuts, flax, canola and soy.

The same Harvard group identified the deleterious effects on cardiovascular health of trans fatty acids in their cohort studies and this has resulted in a major effort to remove trans fatty acids from the food supply. On the other hand their identification of the benefits of vitamin E in their cohort studies has not been confirmed by subsequent randomized controlled trials. Although Dr Willett, the senior member of the Harvard group, has drawn surprisingly little attention to the negative findings with ALA, it remains a sticking point with regulators in the current debate over the inclusion and use of ALA in the food supply. This concern has been sufficient for the Natural Health Products Directorate of Health Canada to ask for a full proposal from us before we start studies on ALA in the prevention of atrial fibrillation due the apparently negative impact of ALA consumption on prostate cancer.

ALA and Prostate Cancer

Studies of Serum PSA to Help Resolve the Current Implication of Alpha-linolenic Acid (ALA) and Prostate Cancer

University of Toronto

Principle Investigator

Ibuprofen

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

standard care plus multimodal intervention consisting of nutritional supplements and advice, home-based self-assisted exercise program, and anti-inflammatory medication (ibuprofen)

standard care

nutritional supplements and advice

home-based self-assisted exercise program

Stein Kaasa, MD PhD

Marie Fallon, MD PhD

Cancer cachexia is a multi-factorial syndrome defined by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment.

There is an urgency for improving management, but there is no consensus on the optimal treatment for cancer cachexia. Several single therapies for cancer cachexia have been examined in clinical trials, with disappointing overall results. As multiple factors are responsible for the development of cachexia, it has been argued that optimal cachexia interventions should target all components: multimodal therapy for a multimodal problem.

The overall aim of this study is to early prevent the development of cachexia rather than treatment late in the disease trajectory. From a patient perspective a short term effect will be to improve physical and psychological function, to reduce symptom burden and to improve survival. In other words live a longer and better life during and after chemotherapy. Direct effects of the cachexia intervention are expected to be reduction of weight and muscle loss, and improved physical activity and quality of life.

Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy

A Randomised, Open-label Trial of a Multimodal Intervention (Exercise, Nutrition and Antiinflammatory Medication) Plus Standard Care Versus Standard Care Alone to Prevent/Attenuate Cachexia in Advanced Cancer Patients Undergoing Chemotherapy

Cantonal Hospital of St. Gallen

Ottawa Regional Cancer Centre

Jewish General Hospital

Cross Cancer Institute

The Beatson West of Scotland Cancer Centre

Queen Margaret Hospital, Dunfermline

Cancer Research UK Edinburgh Centre

Malteser Krankenhaus Seliger Gerhardt

Tumor Biology Center Freiburg

Tumor Zentrum Aarau

Chelsea and Westminster NHS Foundation Trust

Cedars-Sinai Medical Center

Guy's and St Thomas' NHS Foundation Trust

NHS Forth Valley

Fatigue

Herbal and Botanical

Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship.

Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.

12 weeks of time-restricted eating (10-hour window)

Time-restricted eating

Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks

Healthy lifestyle education

Amber Kleckner, PhD

This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 to one of two arms: time-restricted eating or control. Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. This study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism.

The hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels.

Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

Time-Restricted Eating to Address Persistent Cancer-Related Fatigue: The Fatigue REDuction After Cancer (FREDA) Trial

To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.

FACIT-F fatigue subscale scores will be compared for those in the time-restricted eating group vs. the control group at week 12, controlling for baseline levels. This questionnaire is 13-items long, and a higher score indicates less fatigue.

National Center for Advancing Translational Sciences (NCATS)

University of Maryland, Baltimore

Assistant Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rehabilitation for Head and Neck Cancer	NCT02439892	Head and Neck N...	Exercise and nu... Multidimensiona...	18 Years - 85 Years	Norwegian University of Science and Technology
A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study	NCT01419145	Cancer Cachexia	Multimodal inte... Standard care	18 Years - 80 Years	Norwegian University of Science and Technology
ALA and Prostate Cancer	NCT00309439	Atrial Fibrilla... Diet Therapy Prostate Cancer	ALA-rich diet	18 Years - 77 Years	University of Toronto
Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy	NCT02330926	Cachexia Neoplasms	standard care nutritional sup... home-based self... Ibuprofen	18 Years -	Norwegian University of Science and Technology
Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy	NCT02330926	Cachexia Neoplasms	standard care nutritional sup... home-based self... Ibuprofen	18 Years -	Norwegian University of Science and Technology
ALA and Prostate Cancer	NCT00309439	Atrial Fibrilla... Diet Therapy Prostate Cancer	ALA-rich diet	18 Years - 77 Years	University of Toronto
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue	NCT05256888	Neoplasms Therapy Fatigue Diet Therapy Time Survivorship Fasting, Interm...	Time-restricted... Healthy lifesty...	18 Years -	University of Maryland, Baltimore

Spots Global Cancer Trial Database for diet therapy

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