Infections

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Recurrence

Leukemia

Communicable Diseases

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Clostridium Infections

Leukemia, Lymphoid

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Disease Attributes

Neoplasms by Histologic Type

Hematologic Diseases

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Acute Graft Versus Host Disease

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Based on participant food preferences, diet higher in fiber and lower in fat than the participant's typical diet will be provided.

No diet changes will be made for participants

The dietary fiber intake target will be 19 g/d for ages 9-18 and females age 19 and older and 23g/d for males age 19 and older.

Diet Intervention

Catherine Lozupone

The primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces C. difficile infection recurrence in a cohort of oncology patients.

This is a randomized study. A total of 124 individuals with either acute leukemia or lymphoma and a first or second occurrence of C. difficile infection will be enrolled. Participants will be randomized to Arm 1 (Diet intervention) or Arm 2 (No diet intervention). Participants in Arm 1 will be assessed for food preferences and will be provided lists of high fiber and high saturated fats. Participants will be able to choose foods from the high fiber food lists and groceries will be provided once per week to support each participant's meal plan. Participants will be asked to limit foods on the high saturated fats list. Food consumption with a 24 hour recall and weight will be monitored and stool samples will be collected one time per week for 6 weeks. In Arm 2, participants will be asked to provide 24 hour food recall and stool samples. Individuals in both arms will be monitored for stool consistency and any antibiotics or chemotherapy drugs taken. Participation will last 6 weeks.

High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology

Do Decreased Dietary Fat and Increased Fiber Reduce Recurrence of Clostridioides Difficile Infection in Oncology Patients?

Signs of active diarrhea using Bristol stool scale. The Bristol stool form scale includes seven types of stool which ranging from constipation (type 1) to diarrhea (type 7).

Quantify toxins in stool using "Separate detection of C. difficile toxins A and B" kit (tgc Biomics)

Characterize the microbiome in fecal samples as using 16S rRNA targeted and shotgun metagenomic sequencing

National Cancer Institute (NCI)

National Institute of Allergy and Infectious Diseases (NIAID)

University of Colorado, Denver

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Bevacizumab

Cyclophosphamide

Methotrexate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.

The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.

The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.

Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months

The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.

Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months

Lifestyle: Diet

Lifestyle: Diet+Exercise

Erica Mayer, MD

If residual breast cancer is found in the breast or lymph node tissue removed after preoperative chemotherapy, one may be at increased risk of breast cancer recurrence in the future. The purpose of this research study is to determine if having additional treatment after preoperative chemotherapy and surgery with bevacizumab and metronomic chemotherapy would make a difference in reducing the participants chance of breast cancer recurrence compared to the standard of care, which is observation alone. This study will also evaluate the potential additional benefits from participating in an exercise and dietary intervention compared to the dietary intervention alone. Because no one knows which which post-neoadjuvant strategy is best, participants will be "randomized" to one of the study groups: 1. Diet Intervention arm, 2. Diet and Exercise Intervention Arm, 3. Bevacizumab, cyclophosphamide, methotrexate and diet intervention, 4. Bevacizumab, cyclophosphamide, methotrexate, diet and exercise intervention arm.

Bevacizumab is an antibody that is made in the laboratory. Bevacizumab works differently from the way chemotherapy drugs work. Bevacizumab works to slow or stop the growth of cells in cancer tumors by decreasing the blood supply to tumors. Bevacizumab has been approved by the U.S Food and Drug Administration to treat advanced colorectal, lung and kidney cancers. Metronomic chemotherapy also attacks tumor blood supply. Standard chemotherapy drugs are used, cyclophosphamide and methotrexate (CM), but in very small daily doses by mouth, well below the threshold where they can cause people to feel sick. Previous research studies have shown that women with breast cancer who take metronomic CM and bevacizumab feel very well, and the combination therapy is active in reducing their cancer. Participants in this study will also be provided with diet or diet and exercise counseling over the telephone. Studies have shown that many women who are treated for breast cancer will gain weight during and after their treatment, and may also experience fatigue and weakness. Many studies have shown that making changes in diet and increasing exercise can help prevent weight gain and also may increase energy and decrease other side effects of chemotherapy and other breast cancer treatments.

Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer

ABCDE: A Phase II Randomized Study of Adjuvant Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer

RFS events is defined as the duration of time from randomization to time of an RFS event, marked as positive if any of listed event shows: local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive), any other second cancer (excluding non-melanomatous skin cancer or cervical cancer in situ), or death from any cause. The diagnosis of local or distant recurrence should be pathologically confirmed however if biopsy if not possible, radiology confirmation acceptable.

The feasibility of post-adjuvant maintenance metronomic chemotherapy is open to women with hormone receptor negative tumors and either node negative or node positive disease.

Adverse event evaluations will occur at each study visit throughout the treatment period of 2 years and will continue every 6 months during the follow-up period. Only Grade 3/4 AE (CTCAE v4) was reported.

Exercise and/or dietary lifestyle interventions defined per protocol. The lifestyle intervention will be administered by telephone, supplemented with a participant workbook (Appendix 9 in protocol). Only Grade 3/4 AE (CTCAE v4) was reported.

Change in level of fasting insulin from baseline at study entry to 6 months.

data not collected due to early termination of the study.

Change in level of insulin-like growth factor -1 (IGF-1) from baseline at study entry to 6 months.

To evaluate the impact of changes in diet and physical activity upon biomarkers associated with breast cancer risk and prognosis, including leptin, adiponectin, testosterone, estradiol and inflammatory mediators (including: TNF alpha, IL-1 beta, IL-2, IL-5, IL-6, IL-8, IL-10, and IL-12)

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Translational Breast Cancer Research Consortium

Genentech, Inc.

Dana-Farber Cancer Institute

Erica Mayer, M.D.

Lifestyle: Diet+Exericise

Lifestyle: Diet and Bevicizumab+CM

Lifestyle: Diet+Exericise and Bevicizumab+CM

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

The study was terminated early due to slow accrual and therefore interpretation of results is limited.

Erica Mayer MD MPH

The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.

Lifestyle: Diet

The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.

Lifestyle: Diet

Lifestyle: Diet+Exercise

The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.

Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months

Bevacizumab

Cyclophosphamide

Methotrexate

Lifestyle: Diet

The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.

Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months

Bevacizumab

Cyclophosphamide

Methotrexate

Lifestyle: Diet

Lifestyle: Diet+Exercise

Median 3-year Recurrence-free Survival (RFS)

Feasibility Rate

Number of Serious Adverse Event of Bevacizumab

Number of Serious Adverse Event of Metronomic Chemotherapy

Number of Serious Adverse Event (AE) of Lifestyle

Change in Level of Fasting Insulin

This outcome will not be analyzed because there is not enough power to draw a meaningful conclusion on estimates due to early termination of the study.

Change in Body Weight

Results are not provided because the small sample size potentially identifies participants.

Change in IGF-1

Changes in Diet and Physical Activity Upon Biomarkers

Patients in observation group will receive following diet or diet + exercise intervention.

The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.

Observation + Diet/Diet and Exercise

Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months Patients will receive diet or diet + exercise intervention.

Bevicizumab+CM

Changes in Physical Activity and Dietary Behaviors

Impact Upon Anthropometric Measures, Quality of Life and Fatigue

Overall Study

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Oculocerebral Syndrome With Hypopigmentation

Group 1: Modified MAC diet (first 3-weeks) followed by conventional diet (second 3-weeks)

Group 2: Conventional diet (first 3-weeks) followed by modified MAC diet (second 3-weeks)

* Modified MAC diet to adapt reduced energy intake and increased dietary fiber consumption with appropriate nutrients component
* Dr.Kitchen Inc. directly provide home delivery service for the modified MAC diet including multigrain rice, meal kit, and snacks per day in a regular basis

Modified MAC diet (3-weeks)

Soohyeon Lee, M.D., Ph.D.

Soohyeon Lee

To explore the changes in the composition and diversity of intestinal microbiota during 3-weeks of modified MAC diet and conventional diet in stage I or low-risk stage II colorectal cancer (CRC) patients after surgery. Additionally, the investigator analyze the association of gut microbiota and stool formation pattern or quality of life according to dietary pattern. Therefore, the investigator identify the beneficial or harmful microbiota composition and diversity adapting modified MAC diet that related to cancer recurrence, which provide supporting evidence for future prospective trial.

Colorectal cancer is the third most common cancer worldwide and a life-threatening disease that kills more than 500,000 people every year. It is known that, environmental factors such as diet and lifestyle play an important role in the development of colorectal cancer due to large differences in the incidence rate by region in addition to the genetic background associated with colorectal cancer. The physical activity, whole grains, dietary fiber, dairy products, and calcium supplement intake are factors that inhibit colorectal cancer, but red meat, processed meat, alcohol, and obesity act as risk factors inducing colorectal cancer. Therefore, it can be said that efforts to prevent cancer are important compared to other cancers.

A growing interest in the interaction of the gut microbiome with its host and its important role in health and disease is revealing that the interaction of the gut microbiome with humans plays an important role in the development of degenerative diseases, cancers and inflammatory diseases. According to recent studies, the risk of colorectal cancer is increased by the presence of specific gut microbiota, dysbiosis, and the interaction between diet and gut microbes. In other words, changes in diet affect the formation of the intestinal microbiota, and conversely, microorganisms mediate the generation of dietary factors that cause colorectal cancer.

In addition, microorganisms such as Fusobacterium nucleatum regulate autophagy and play a role in making it resistant to chemotherapy after colon cancer surgery, or whole grains in colorectal cancer patients with Fusobacterium nucleatum in tumor tissue. However, a cohort study has also reported that consuming a diet rich in dietary fiber helps to lower the incidence of colorectal cancer.

Diet and nutrients play a decisive role in the composition of the intestinal microflora involved in the regulation of inflammation and immune responses.

Microbiota-Accessible Carbohydrates (MAC) refer to carbohydrates that the human intestine cannot digest, but that can be digested by intestinal microbes. It is not decomposed and not absorbed in the stomach or small intestine, and then broken down in the large intestine and then digested and metabolized by the intestinal microflora. During that process, short chain fatty acid (SCFA) is produced, which is known to increase beneficial intestinal bacteria and decrease inflammation around intestinal cells.

The composition of intestinal microbes changes due to intestinal preparation before colon cancer surgery, use of prophylactic antibiotics, and tissue changes in the intestine anastomosis, which may lead to enhanced toxicity, proliferation of pathogens, and reduction of beneficial intestinal bacteria. In addition, the presence of certain microorganisms may lead to complications such as anastomotic leakage or infection at the surgical site.

Thanks to the development of various genomic research techniques, there is a difference in the composition of intestinal microbes between colorectal cancer patients and healthy people, and the microbiome affects the development of adenoma or cancer as the number of beneficial bacteria decreases, the harmful bacteria changes in terms of age.

In this study, a modified MAC diet designed to adapt to a high-fiber diet after surgery and a patient-made diet for stage 1-2 colorectal cancer patients who do not receive chemotherapy after colon cancer surgery using the genomic analysis technique The purpose of this study is to explore the effect of diet on the composition of the intestinal microflora, and to analyze whether the different diet affects the pattern of defecation after colorectal cancer surgery, and the effect of these changes on the quality of life after colorectal cancer surgery.

Approximately 40 participants will be randomly assigned to following group (group 1 or group 2). The subjects will be consumed the modified MAC or conventional diet for first 3-weeks period then cross-over to second 3-weeks period.

Modified MAC Diet and Gut Microbiota in CRC Patients

A Modified Microbiota-Accessible Carbohydrates (MAC) Diet and Change of Gut Microbiota in Patients With Colorectal Cancer After Surgery: A Prospective, Open-label, Cross-over, Single Center Study

a-diversity for interpersonal change and b-diversity for groups using 16s rRNA sequencing

Daily check for stool pattern using Bristol Stool Score

3 times check for quality of life using EORTC QLQ-C30 plus QLQ-CR29 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 items for Common function and symptom plus 29 items specific for colorectal cancer, It is converted into a score range from 0-100, and the overall quality of life score is high, The higher the functional domain score and the lower the symptom domain score, the better the quality of life.)

3 times check for quality of life using EORTC QLQ-C30 plus QLQ-CR29

Analysis for gut microbiota producing short chain fatty acid

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology	NCT04940468	Leukemia, Lymph... Leukemia, Myelo... Lymphoma Clostridium Dif...	Diet Interventi...	9 Years -	University of Colorado, Denver
Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer	NCT00925652	Breast Cancer	Bevacizumab Cyclophosphamid... Methotrexate Lifestyle: Diet Lifestyle: Diet...	18 Years -	Dana-Farber Cancer Institute
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology	NCT04940468	Leukemia, Lymph... Leukemia, Myelo... Lymphoma Clostridium Dif...	Diet Interventi...	9 Years -	University of Colorado, Denver
Modified MAC Diet and Gut Microbiota in CRC Patients	NCT05039060	Colorectal Canc... Gut Microbiota Diet Interventi...	Modified MAC di...	19 Years -	Korea University Anam Hospital
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology	NCT04940468	Leukemia, Lymph... Leukemia, Myelo... Lymphoma Clostridium Dif...	Diet Interventi...	9 Years -	University of Colorado, Denver

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