Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Body Weight

Body Weight Changes

Breast Diseases

Skin Diseases

Anne Gilmore, PhD

Twenty-five women will be followed through their breast cancer treatment. The women will be asked to provide their opinions and desires for lifestyle intervention at different times throughout treatment. In addition, basic clinical data will be collected . The primary goal of this pilot study is to investigate the physical and behavioral changes that occur in patients receiving treatment for breast cancer.

In this cross sectional, longitudinal, observational study, 25 women will be followed through their treatment for stage I-III breast cancer. The women will be asked to provide their opinions and desires for lifestyle intervention at four timepoints throughout treatment. In addition to qualitative data, basic clinical data will be collected (anthropometrics, vital signs, dietary intake, and physical activity). The primary goal of this pilot study is to investigate the anthropometric and behavioral changes that occur in patients undergoing adjuvant chemotherapy for breast cancer.

Aim 1: To better understand patients' attitudes toward and perceived barriers to nutrition and physical activity interventions during neoplastic treatment.

Hypothesis: Patients' reported attitudes, motivation, and perceived barriers will change throughout treatment.

Aim 2: To measure the physical and metabolic changes that occur throughout neoplastic treatment for breast cancer.

Hypothesis: Over 50% of the participants will gain body weight during treatment and metabolic parameters will trend with body weight change.

Plasma and serum will be stored for future research

Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment

Qualitative data collected via semi-structured interview

24 hour recall (ASA24) to assess food intake changes throughout treatment

Wrist worn Actigraph accelerometer to assess activity changes throughout treatment

Pennington Biomedical Research Center

Assistant Professor

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Dermatologic Agents

Vitamins

Herbal and Botanical

Vitamin D

Cholecalciferol

Sunscreening Agents

Vitamin D3

Calciferol

Coconut

Olive

The Paleolithic lifestyle (PL) intervention during radiotherapy consists of daily outdoor walks or bike rides of at least 30 min duration, preferably done at noon to maximize vitamin D production, and the adoption of a Paleolithic diet. For the outdoor activity, patients were told to not use sun screen. The Paleolithic diet prescription emphasized the consumption of fatty meats and organ meats from humanely raised animals, wild-caught fish, eggs, nuts and seeds, algae, spices, vegetables and fruits. Excluded were processed foods, grains of all types, legumes, vegetable oils except for native coconut and olive oil and dairy products except for ghee. No dietary supplements were allowed. Patients were supposed to start the PL intervention at least two days prior to the first irradiation and to protocol their food consumption on two days during the first week on the diet. They were also asked about their compliance to the PL intervention at each weekly measurement appointment.

This group is on a standard diet while receiving radiotherapy.

Curative radiotherapy

This intervention consists of daily outdoor walks or bike rides of at least 30 min duration, preferably done at noon to maximize vitamin D production, and the adoption of a Paleolithic diet. For the outdoor activity, patients were told to not use sun screen. The Paleolithic diet prescription emphasized the consumption of fatty meats and organ meats from humanely raised animals, wild-caught fish, eggs, nuts and seeds, algae, spices, vegetables and fruits. Excluded were processed foods, grains of all types, legumes, vegetable oils except for native coconut and olive oil and dairy products except for ghee. No dietary supplements were allowed.

Paleolithic lifestyle intervention

The study aims to test the feasibility and effects of a dietary and physical activity intervention based on evolutionary considerations in an oncological setting.

A total of 13 breast cancer patients referred to our clinic for curative radiotherapy were recruited for this pilot study. The women were supposed to undertake a "Paleolithic lifestyle" (PL) intervention consisting of a Paleolithic diet and daily outdoor activity of at least 30 min duration while undergoing radiotherapy. Body composition was measured weekly by bioimpedance analysis. Blood parameters were assessed before, during, and at the end of radiotherapy. A control group on an unspecified standard diet (SD) was assigned by propensity score matching.

Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy

Short-term Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy: A Pilot and Feasibility Study

Will be made available upon reasonable request. Plan is also to publish all data of this and the KETOCOMP study (NCT02516501) together as soon as all analyses have been published.

Used to measure feasibility. The intervention is rated as feasible if dropout rate is \<30%

Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany)

Difference between final (average 5 weekks) and baseline 25-hydroxyvitamin D level

Change between baseline and final (average 5 weeks) beta-hydroxybutyrate levels

MVZ Leopoldina GmbH

Principle investigator

Head and Neck Neoplasms

Weight Loss

Pharmaceutical Solutions

Amino Acids

Other Dietary Supplements

Arginine

Omega 3 Fatty Acid

Whey Protein

Glutamine

Three sessions per week of concurrent training during radiotherapy period. Each session will begin with warm-up (5-min cardiovascular activity at low-moderate intensity, joint mobility and one set of resistance exercises circuit at 30-40% 1RM). Resistance training will follow the warm-up, including 9 standard exercises involving major muscle groups of the lower and upper body: vertical bench press, parallel bar dip for triceps, seated rowing, standing dumbbell curl for biceps, leg press, deadlift and shoulder press. All these exercises will be realized following circuit training with 4 sets of 8-12 repetitions, using a training load of 70-80% RM. When patient will able to complete more than 12 repetitions, load will be increased progressively 10%. Cardiovascular training will be completed 20-30 min after resistance training, and it will include High-Intensity Interval Training (HIIT) of 3 min near to the second ventilatory threshold and 2 min near to the first ventilatory threshold.

Prescribed diet controlling macronutrients according to patient body weight (\~4g/kg/day for carbohidrates, \~2g/kg/day for proteins, and \~1g/kg/day for fats). Patient will take one single dosage per day of probiotics (Arkoprobiotics® Defenses), 1 or 2 capsules of omega-3 fish oil concentrate (Solgar®, 600-1200mg depending on fat sources intake during the day), and a combine ingestion of 3g beta-hydroxybeta-methylbutyrate (HMB), 14g arginine, and 14g glutamine (HSN Raw Series®, all pure ingredients and making the ingestion adding each of them individually in a solution with 300-400 ml of water). During concurrent training sessions, between resistance exercise and HIIT, patient will also take 6g of BCAA's (HSN Raw Series®, 2:1:1) along with a banana. Additionally, patient could take whey isolated protein (Amix® IsoPrime CFM) to meet with some of the prescribed proteins intakes.

Physical exercise controlled program supervised by an accredited exercise specialist

Physical exercise

Nutritional management controlled by a PhD clinical and sport nutrition specialist

Nutritional management

A case control study with before-after design. A concurrent training and a nutritional management intervention was offered by a patient with head and neck cancer, in order to compare outcomes related to strength and endurance performance and to body composition

Cancer causes important public health problems around the world and it is one of the most frequent cause of death overall. Among non-pharmacological treatment, physical exercise has shown improvements in different types of cancer and patients, but it is important to define the optimal dose. Our aim is to determine the effects of a concurrent training program and a nutritional management developed during radiotherapy treatment on physical performance and body composition. A patient with an oral cavity cancer will develop three sessions per week of concurrent training: resistance training included 9 standard exercises involving major muscle groups (4x8-12 RM), and cardiovascular training included a High-Intensity Interval Training (HIIT). Nutritional management will include a diet controlling macronutrients (\~4g/kg/day for carbohidrates, \~2g/kg/day for proteins, and \~1g/kg/day for fats), along with some nutritional supplements such as beta-hydroxybeta-methylbutyrate (HMB), arginine, glutamine, omega-3 fish oil concentrate, and BCAA's during training sessions. Intervention took place during radiotherapy period (7 weeks). We expect that body composition will remain invariable, and 1RM will increased. VO2max is expected to be almost the same, but intensity tolerated at maximum VO2max could be higher. If our results confirm that, we could conclude that a combination between resistance exercise and HIIT along with a nutritional management developed during radiotherapy could be effective to prevent muscle mass loss and muscle function decrease in a young patient with oral cavity cancer.

Concurrent Training and Nutritional Management in Cancer

Concurrent Training and Nutritional Management Prevent Body Weight Loss During Radiotherapy in a Young Adult With Head and Neck Cancer: A Case Control Study

Test will be performed in vertical bench press

Test will be performed in a cycloergometer

Universidad Francisco de Vitoria

Principal Investigator

Individual nutritional intervention with two groupal sessions and physical activity.

A nutritional intervention program that consisted of two individual nutritional consults.

Control group

A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures.

Nutrition and physical activity group

Carmen Gómez Candela, Msc

To evaluate a nutritional intervention for women newly diagnosed with breast cancer on a weight control and physical activity program.

56 women newly diagnosed with breast cancer from the Department of Medical Oncology of La Paz University Hospital, Madrid, Spain.

A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures was conducted by physicians of the Nutrition Unit during one year.

A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.

A Standardized Integral Nutritional Intervention 1 and Physical Activity Program

To examine the frequency of food consumption

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment	NCT02887196	Breast Neoplasm... Body Weight Cha...		18 Years -	Pennington Biomedical Research Center
Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy	NCT04574323	Breast Cancer Body Weight Cha...	Curative radiot... Paleolithic lif...	18 Years - 75 Years	MVZ Leopoldina GmbH
Concurrent Training and Nutritional Management in Cancer	NCT03720015	Body Weight Cha...	Physical exerci... Nutritional man...	32 Years - 34 Years	Universidad Francisco de Vitoria
Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy	NCT04574323	Breast Cancer Body Weight Cha...	Curative radiot... Paleolithic lif...	18 Years - 75 Years	MVZ Leopoldina GmbH
Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment	NCT02887196	Breast Neoplasm... Body Weight Cha...		18 Years -	Pennington Biomedical Research Center
A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.	NCT04980118	Breast Cancer Body Weight Cha... Weight Loss Nutrition Relat...	Control group Nutrition and p...	18 Years -	Instituto de Investigación Hospital Universitario La Paz
Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment	NCT02887196	Breast Neoplasm... Body Weight Cha...		18 Years -	Pennington Biomedical Research Center

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