Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Overweight

Breast Neoplasms

Obesity

Body Weight

Weight Loss

Breast Diseases

Skin Diseases

Overnutrition

Nutrition Disorders

Body Weight Changes

Individualized dietary counselling to reduce body weight

Individualized physical activity counseling to reduce body weight

Individualized dietary and physical activity counseling to reduce body weight

Materials and guidelines available to general public

Participants will be offered an individualized dietary counselling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

Participants will be offered an individualized physical activity counseling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

Participants will be offered an individualized dietary and physical activity counseling to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

PADI

Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.

Patrick Maisonneuve

The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused on weight loss in a group of overweight or obese women previously treated for early breast cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase physical activity and decrease sedentary time, taking advantage of a pedometer-like device.

The InForma project is designed as a mono-institutional randomized controlled 4-arm parallel-group trial. Potential study participants will be recruited among all overweight or obese breast cancer patients previously treated at the European Institute of Oncology (IEO). Potential study participants will be recruited after breast cancer treatments (surgery, chemotherapy and and/or radiation) will be completed. Study participants will be randomized to one of the 4 arms: DI - Dietary Intervention; PAI - Physical Activity Intervention; PADI - Physical Activity and Dietary Intervention; LII - Less Intensive Intervention. Enrolled patients will receive a 6-month intervention and will be followed until the end of the study period with two additional follow-up visits at 12- and 24-month. The main aim of the study is to evaluate the impact of the intervention programme on body weight change in overweight or obese breast cancer patients.

Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer

Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer: A Four-arm Randomized Trial

weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer

long-term weight control or maintenance via calibrated scales, stadiometer

change in total step count via pedometer device with electronic data transmission

change in physical activity and inactivity levels via IPAQ-International physical activity questionnaire

change in dietary intake via Food Frequency Questionnaire

change in quality of life via Functional Assessment of Cancer Therapy-Breast (FACT-B)

change in mood via State-Trait Anxiety Inventory (STAI) questionnaires

change in LDL, HDL, triglycerides and cholesterol assessed by blood samples

change in oestradiol assessed by blood samples

change in insulin assessed by blood samples

change in glucose assessed by blood samples

change in C-reactive protein assessed by blood samples

Associazione Italiana per la Ricerca sul Cancro

European Institute of Oncology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Uterine Neoplasms

Endometrial Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Subjects in the assisted exercise group will cycle on the same stationary exercise bike; however, a motor will provide assistance to the patient in order to maintain a pedaling rate 35% greater than their voluntary rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks.

Subjects in the voluntary group will exercise on a stationary recumbent exercise cycle and pedal at their preferred rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks.

Exercise on stationary recumbent exercise cycle

Informational brochure ("Better Health and You," Weight Control Information Network, June, 2004)

Health Education

Questionnaires

Imaging data will be acquired on a Siemens 3.0T Wide-Bore Verio MRI scanner.

Neuroimaging

Patients will be asked to fast for approximately 12 hours and will have approximately 2 Tbs. of blood drawn at baseline and the end of treatment (EOT).

Genetic and Biomarkers

Nora Nock, PhD

This is an assisted exercise trial involving exercise on a stationary bike, brain imaging and DNA(genetics)sampling. The purpose of this study is to find out if performing a progressive, supervised assisted exercise program on a stationary bike improves quality of life, increases motivation to continue to exercise, improves dietary behavior and leads to sustained weight loss in women who have had early-stage endometrial cancer. Questionnaires will be used to assess exercise motivation and dietary behavior. Brain's responses to different visual images will also be assessed.

Primary Objective:

To evaluate changes in body weight, fitness, bi-manual dexterity, exercise motivation and self-reported eating behavior (via questionnaires) before and after a 16-week exercise intervention (EOT) and 12 and 24 weeks post-EOT, in obese EC patients who will be randomized to perform 'assisted' or voluntary exercise.

Secondary Objectives:

Objective 1: To objectively examine food behavior as determined by neuronal response to high- versus low-calorie visual stimuli under fasted (hunger) and fed (satiated) states and stop/go signaling (SST) in fed states in brain regions of interest (reward and motivation circuitry) using blood oxygenation level dependent (BOLD) functional MRI before and after a 16-week exercise intervention (EOT) and 12 and 24 weeks post-intervention in obese EC patients performing 'assisted' and voluntary exercise.

Objective 2: To examine the modification of the neuronal response to high vs. low calorie food images in regions of interest by polymorphisms in key genes (e.g., dopamine receptor and dopamine transporter) and serum biomarkers (e.g., leptin, BDNF) involved in regulating homeostatic and non-homeostatic energy systems.

Patients will be randomized to receive either the assisted exercise (n=60) or voluntary exercise (n=60) group. Subjects in the voluntary group will exercise on a stationary recumbent exercise cycle and pedal at their preferred rate. Subjects in the assisted exercise group will cycle on the same stationary exercise bike; however, a motor will provide assistance to the patient in order to maintain a pedaling rate 35% greater than their voluntary rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks. The control group will be asked to complete all exercise, body composition and fMRI testing similar to the exercise groups.

Assisted Exercise in Obese Endometrial Cancer Patients

REWARD (Revving-Up Exercise for Sustained Weight Loss by Altering Neurological Reward and Drive): A Randomized Trial of Assisted Exercise in Obese Endometrial Cancer Patients

Body fat, lean mass and bone mass will be measured with a Lunar iDXA™ (GE Healthcare, Madison, WI. BMI will be computed (weight in kg divided by square of height in meters) and categorized as: \< 18.5 (underweight), 18.5 to 24.9 (normal weight), 25.0 to 29.9 (overweight)

Evaluate motivation to exercise using the Exercise Motivations Inventory (EMI-2) 122 and the Intrinsic Motivational Inventory (IMI) modified for exercise. Past physical activity habits will be assessed with the Godin Leisure-Time Exercise (LSI) questionnaire.

Eating behavior will be assessed using the Three-Factor Eating Questionnaire (TFEQ). The TFEQ includes 51 items and addresses three dimensions of human eating behavior; restraint, disinhibition, and perceived hunger.

The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item core questionnaire evaluating various domains of QoL including, physical, functional, family-social, and emotional well-being. The FACT-En is a 16-item subscale specific for endometrial cancer (EC) and assesses hormone withdrawal, pelvic symptoms, and possible adjuvant therapy side effects. Short-form Medical Outcomes (SF-36) consists of 36 questions scored on a Likert scale, producing overall physical and mental component summary measures.

The Beck Depression Inventory (BDI) is a 21-item, Likert-scaled instrument of depressive symptoms that is well-validated and frequently used in lifestyle research studies. Each item is rated on a 4- point scale ranging from 0 to 3 (higher scores are associated with greater symptoms).

Barriers to adhering to the exercise protocol will be assessed prospectively using an elicitation procedure similar to that suggested in the theory of planned behavior, whereby an open-ended question is asked to solicit the barrier without any preconceived notion of what the barrier might be. Specifically, participants in the exercise groups will be asked to book their weekly supervised exercise sessions with the Exercise Specialist/Physiologist. Participants cancelling an exercise session or requesting to be removed from the study will be asked why they are no longer interested in completed the program.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer	NCT02622711	Breast Cancer	DI PAI PADI LII	18 Years -	European Institute of Oncology
Assisted Exercise in Obese Endometrial Cancer Patients	NCT01870947	Stage I Endomet... Uterine Cancer Obesity	Exercise on sta... Health Educatio... Questionnaires Neuroimaging Genetic and Bio...	18 Years -	Case Comprehensive Cancer Center
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer	NCT02622711	Breast Cancer	DI PAI PADI LII	18 Years -	European Institute of Oncology

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