Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Overweight

Syndrome

Obesity

Infertility

Polycystic Ovary Syndrome

Overnutrition

Nutrition Disorders

Body Weight

Genital Diseases

Urogenital Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. We will also ask participants to keep foods low in fat and low in glycemic index.

A low-calorie diet contains all food groups. However, participants will be provided with a calorie goal which should promote weight loss.

Diet

Brie Turner-McGrievy, PhD, MS, RD

This study will be a 6-month intervention that is examining how different dietary approached may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy, particularly by measuring changes in weight. Participants will be randomly assigned to following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic index, which means you will be asked to favor foods that don't cause a quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will receive counseling and supporting materials on the dietary approach you are assigned to follow. Both diets are safe and have shown to be effective ways to assist with achieving a healthy weight. The investigators hypothesize that both groups will see improvements in weight and fertility with possible greater improvements seen among participants in the vegan group.

This study involves two groups. You will be randomly assigned to one of these groups (i.e. you do not have a choice for group assignment) which means your group will be assigned to you by chance, like flipping a coin. Both groups will be assigned to receive information on a dietary approach to lose weight. One group will receive instruction on a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day). The other group will be instructed on how to follow a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic index, which means you will be asked to favor foods that don't cause a quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Below are the steps in the study:

* If you are accepted into the study, you will come to the study site (USC School of Public Health) to learn more about the study and complete your consent form. If you live outside the Columbia, SC area (more than a 6o mile drive), then you may complete orientation to the study over the phone and Web. You will then be mailed a consent form which we will discuss over the phone. You can then sign the consent form (keeping one copy for yourself and having a witness sign it as well) and mail it back. Once that is received by study personnel, a copy with a research personnel's signature will be mailed back to you. You may then begin the study.
* This study will involve 3-4 in-person visits to the School of Public Health at USC's Columbia campus, each lasting less than 2 hours each.
* You will then complete some questionnaires that will measure your diet and physical activity levels at home from a computer.
* You will come back for a meeting to have your weight, height, waist, and hip circumference measured. You will then be randomly assigned to one of the two groups: calorie controlled group or vegan diet group. You will receive a one-hour overview of the diet you have been assigned to and be provided with materials on this diet.
* During the study, we will ask you to complete a weekly questionnaire which will assess if you are following the diet, your weight, and ask for information on your menstrual cycle. This will take approximately 5 minutes to complete.
* You will then be provided individualized feedback each week via e-mail on your progress, along with a weekly lesson on the topic for the week.
* You will also have access to a group website (a private Facebook group) that will provide group support. Participation using this group is optional.
* You will be provided with test strips to monitor ovulation each month and pregnancy tests (1 per month) to monitor pregnancy status. You will report these results to us via online survey.
* Study personnel will host a weekly 30 minute webinar for your diet group online. This will take place after work time on a weekday. Make-up sessions by phone during the work day will be available.
* At 3 months, you will be asked to complete another set of questionnaires from home and return to our study site for your weight, waist, and hip circumference measurements. You will receive a $10 incentive for completing the 3-month assessment. You will also receive a $5 incentive each month that you provide your menstrual cycle data (using the test strips) and pregnancy tests results-which you will receive at the 3 month meeting (for a total of $25 possible at month 3).
* You will then continue the study for the next 3 months.
* At study completion (6 months), you will complete the last set of questionnaire (online from home). Also, you will come to a follow-up assessment to be weighed, have your waist and hip circumference measured, and to receive your incentive for participating ($10 +$5/month of each menstrual cycle data submitted for a total of $25 possible).
* If you become pregnant during the course of the study, you will be advised to consult your care provider. Because this is a weight loss study, we cannot allow continued participation but would like to record your weight measurement and other questionnaire data prior to study discontinuation. If you choose to continue to follow your assigned dietary approach, we can provide information on the diet to your physician, who can advise you on how to proceed.
* Participants in both groups will be asked to take a daily prenatal vitamin (or other reliable source of vitamin B-12) over the course of the study.
* During the study, we will ask you to keep your physical activity levels constant (keep your levels the same as what you were doing at study entry).

Healthy Eating for Reproductive Health (HERHealth)

body weight will be assessed at 0, 3, and 6 months

We will measure any occurrences of pregnancy over the course of the study

We will measure changes in the length of menstrual cycles over the course of the 6 month study

Academy of Nutrition and Dietetics

University of South Carolina

Associate Professor

Skin and Connective Tissue Diseases

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

60-72 h-modified fasting (36-48 h before and 24 h after chemotherapy)

60-72 h-vegan diet (36-48 h before and 24 h after chemotherapy)

Patients follow a modified fasting regime of 60-72 h (36-48 h before and 24 h after CT) with a dietary energy supply of 350-400kcal per day with vegetable juices during the first four cycles of CT. During the rest of the CT cycles they will observe two days of caloric restriction (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed and the patients are encouraged to follow a pattern of time restricted feeding with 14 h fasting over night at least for six days a week. The patients will receive an individual nutrition training by trained nutritionists.

Fasting

Patients follow a 60-72 h vegan diet with sugar restriction (36-48 h before and 24 h after CT) during the first four cycles of CT. During the rest of the CT cycles they will observe two days of vegan and sugar-restricted diet (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed. The patients will receive an individual nutrition training by trained nutritionists.

Vegan

Andreas Michalsen, Prof. Dr.

The aim of this trial is an evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with breast cancer and ovarian cancer in respect to quality of life, reduction of side effects and possible reduction in tumor progression.

Chemotherapy (CT) is a basic element in the therapy of gynecological oncologic diseases besides surgery, antibody therapy, anti-hormonal therapy and radiation. The chemotherapeutic intervention can be experienced physically and psychologically as a severe stress due to unwanted acute and also relevant long term side effects. It is even possible that because of severe side effects the CT can not be continued and main goals of the therapy like tumor reduction or elimination can not be achieved. Except of some medicinal approaches (such as antiemetics) or therapeutic exercise, not many therapeutic approaches are known to help reduce CT induced side effects. Against this background it is important to identify and scientifically evaluate new approaches to reduce the side effects of CT. The aim of this study is to verify the effectiveness of intermittent fasting as a potentially helpful supportive therapy in CT. In a prior pilot study of our institute with 34 breast- and ovarian cancer patients showed beneficial effects of an intermittent fasting of 72-84 h parallel to the application of the CT (manuscript submitted in Cancer Science).

The results of this confirmatory study are therefore of potentially high clinical relevance for all chemotherapeutically treated patients.

Long term goal: This study can lead to the improvement of tolerance and effectiveness of chemotherapeutic tumor therapy through accompanying intense nutritional therapy interventions. Beyond that it can be the starting point of a following multi-center randomized controlled study.

A large variety of animal experimental studies as well as three smaller pilot studies suggest that intermittent fasting can reduce the unwanted side effects of CT and enhance the quality of life. It is being speculated that the anti-tumor effect of fasting is enhanced through the reduction of the Insulin-like growth factor-1 (IGF-1) and mTOR as well as p53-signalling molecules (differential stress resistance).

But it is still unclear whether the possible beneficial effect that intermittent fasting shows can only be reached by subtotal caloric restriction or a significant reduction of the intake of animal proteins and refined sugar could also cause a similar decrease in IGF-1.

Against this background this confirmatory study aims to test the hypothesis that CT in the adjuvant and neoadjuvant treatment of breast- and ovarian cancer is better tolerable under intermittent fasting than under a normo-caloric vegan and sugar-reduced diet.

Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers

Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers - a Randomized, Controlled, Two-armed Intervention Study

According to kind of cancer (breast cancer/ ovarian cancer)

Specific chemotherapy induced effects on quality of life and neurologic symptoms

Chemotherapy-Induced Peripheral Neuropathy Assessment Tool

Documentation according to the standard documentation rules of the German Tumour Centres Work Group, Weight in kilograms

Documentation according to the standard documentation rules of the German Tumour Centres Work Group, BMI in kg/m\^2

Documentation according to the standard documentation rules of the German Tumour Centres Work Group, units auf measure according to SI units

Explorative measurements in blood samples in subgroup of 20 patients

Information taken from the documentation of the treatment, visits and questionnaires

Information taken from the documentation of the treatment, visits, questionnaires and interview

Explorative measurements in capillary blood, only in subpopulation of n=20

Elective items of the "Common Terminology Criteria for Adverse Events (CTCAE)"

Number of histologically proven complete remissions (ypT0ypN0 bzw. ypT0/is) after neoadjuvant CT

Histological classification according to Millar Payne scale

Charite University, Berlin, Germany

Principal Investigator

Weight Loss

Participants in this arm will be instructed on how to reduce their caloric intake and follow a low calorie diet

Participants in this arm will follow a very low fat diet (\~10% kcals from fat) and also a diet that has a low glycemic index and is free of animal products (vegan)

Vegan diet

Low calorie diet

Brie Turner-McGrievy, PhD

This study will be a 6-month intervention that is examining how different dietary approached may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy, particularly by measuring changes in weight. Participants will be randomly assigned to following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic index, which means the consumer will be asked to favor foods that don't cause a quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will receive counseling and supporting materials on the dietary approach the participants are assigned to follow. Both diets are safe and have shown to be effective ways to assist with achieving a healthy weight. The investigators hypothesize that both groups will see improvements in weight and fertility with possible greater improvements seen among participants in the vegan group.

This study involves two groups. You will be randomly assigned to one of these groups (i.e. you do not have a choice for group assignment) which means your group will be assigned to you by chance. Both groups will receive information on a dietary approach aimed at losing weight.

One group will receive instruction on a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day). The other group will be instructed to follow a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this will be a low-glycemic index diet, which means you will be asked to favor foods that don't cause a quick rise in blood sugar (for example, choosing oatmeal over cornflakes for breakfast).

Below are the steps in the study:

If you are accepted into the study, you will come to the study site (Fertility Center of the Carolinas in Greenville) to learn more about the study and complete your consent form. If you live outside the Columbia, SC area (more than a 60 mile drive), you may complete the study orientation process over the phone and Web. You will be mailed a consent form to sign and return to the study coordinator. This study will involve 3-4 in-person visits to the Fertility Center of the Carolinas office, each lasting approximately 1.5 to 2 hours.

You will complete some questionnaires that measure your diet and physical activity levels on a computer at home or other location where you have computer/internet access.

You will come back for a meeting to have your weight measured. You will then be randomly assigned to one of the two groups: calorie controlled group or vegan diet group. You will receive a one-hour overview of the diet you have been assigned to and be provided with materials on this diet.

During the study, we will ask you to complete a weekly questionnaire which will assess if you are following the diet, your weight, and ask for information on your menstrual cycle. This will take approximately 5 minutes to complete.

You will be provided individualized feedback each week via e-mail on your progress, along with a weekly lesson on the topic for the week.

You will have access to a group website (a private Facebook group) that will provide group support. Participation using this group is optional.

You will be provided with test strips to monitor ovulation each month and pregnancy tests (1 per month) to monitor pregnancy status. You will report these results to us via online survey.

Study personnel will host a weekly 30 minute webinar for your diet group online. This will take place after work time on a weekday. Make-up sessions by phone during the work day will be available.

At 3 months, you will be asked to complete another set of questionnaires from home and return to our study site for your weight measurement.

You will continue the study for the next 3 months. At study completion (6 months), you will complete the last set of questionnaires (online). Also, you will come to a follow-up assessment to be weighed and to receive your incentive for participating ($10 +$5/month of each menstrual cycle data submitted for a total of $25 possible).

Participants in both groups will be asked to take a daily prenatal vitamin (or other reliable source of vitamin B-12) over the course of the study.

During the study, we will ask you to keep your physical activity levels constant (keep your levels the same as what you were doing at study entry).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Healthy Eating for Reproductive Health (HERHealth)	NCT01509066	Polycystic Ovar... Infertility Obesity Overweight	Diet	18 Years - 35 Years	University of South Carolina
Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers	NCT03162289	Breast Cancer Ovarian Cancer	Fasting Vegan	18 Years - 75 Years	Charite University, Berlin, Germany
Healthy Eating for Reproductive Health: Greenville	NCT01716429	Polycystic Ovar... Infertility Obesity Overweight	Vegan diet Low calorie die...	18 Years - 35 Years	University of South Carolina
Healthy Eating for Reproductive Health: Greenville	NCT01716429	Polycystic Ovar... Infertility Obesity Overweight	Vegan diet Low calorie die...	18 Years - 35 Years	University of South Carolina
Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers	NCT03162289	Breast Cancer Ovarian Cancer	Fasting Vegan	18 Years - 75 Years	Charite University, Berlin, Germany

Spots Global Cancer Trial Database for vegan

Every month we try and update this database with for vegan 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 vegan

Every month we try and update this database with for vegan 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 vegan 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.