Nutritional and Metabolic Diseases

All Conditions

Neoplasms

Digestive System Diseases

Behaviors and Mental Disorders

Malnutrition

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Nutrition Disorders

Quality of Life

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Receive iPLANT diet plan and diet counselling by a qualified dietitian in oncology setting.

A diet plan which mainly consists of plant-based food will be designed based on participants' energy and protein needs. The counselling covers (1) guidance to achieve energy and protein requirement (2) advice on food to be included in iPLANT diet plan (Mediterranean diet: increase intake of fish and legumes; moderate intake of eggs, dairy, nuts, poultry; limit intake of red meat).

iPLANT diet plan and diet counselling

General dietary advices on how to improve oral intake and maintain healthy weight will be provided.

Usual diet counselling

SHIN LU NG, master

SHIN LU NG

The goal of this intervention study is to investigate the effectiveness of individualized plant-based diet plan on nutritional indices and clinical outcomes in colorectal cancer patients receiving chemotherapy. The main questions to answer are:

1. What are the current eating trends in colorectal cancer patients?
2. What are the common perceptions of adopting a plant-based diet in colorectal cancer?
3. Does iPLANT diet plan improve nutritional indices of colorectal cancer patients?
4. Does iPLANT diet plan improve patients' gastrointestinal side effects and quality of life without compromising their nutritional status?

Participants will be randomly assigned into two arms (intervention and control) using opaque envelop system. Intervention group will receive individualized plant-based diet plan and diet counselling, whereas the control group will receive usual diet counselling.

The researcher will compare the differences in nutritional outcomes and quality of life between intervention and control groups before and after intervention.

Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design

The Prognostic Nutritional Index is used to assess the nutritional status. Respondents are severely malnourished if score less than 40

Higher score indicates higher level of inflammation

The PG-SGA score is derived from components of weight history, food intake, nutritional impact symptoms, and activity function. The possible scores range from 0 (well-nourished) to 37 (worst possible malnourished)

The higher values of skeletal muscle index and phase angle indicate lower risk of malnutrition, whereas higher reading of extracellular water ratio indicates higher risk of malnutrition. Higher body fat mass indicates higher adiposity level.

Respondents develop cachexia if values are less than 32 (male) and 18 (female)

Respondents have weak muscle if the values are 27 or less (male) and 16 or less (female)

EORTC QLQ-CR29 is a validated tool to measure the functional scales and symptomatic level of colorectal cancer that resulted from disease or treatment factors. Possible scores range from 0 to 100, which higher score indicates better functional scale or worse symptomatic level

Higher intake of daily energy and protein indicates improved oral intake

National Cancer Institute, Malaysia

Principal Investigator

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Chronic Disease

Obesity

Breast Neoplasms

Disease Attributes

Breast Diseases

Skin Diseases

Chronic Graft Versus Host Disease

Fear appeal, video message to reduce sugar consumption or risk death

Video of spoken word poem from The Bigger Picture project, "Hear No" by Joshua Merchant; images of African-American male poet interspersed with images of environment

Video of spoken word poem from The Bigger Picture Project, "The Longest Mile" by Tassiana Willis; images of African-American female poet interspersed with images of environment

Video of spoken word poem from The Bigger Picture Project, "A Taste of Home" by Monica Mendoza; images of Hispanic female poet interspersed with images of environment

Video of spoken word poem from The Bigger Picture Project, "Lost in Translation" by Yosimar Reyes; images of Hispanic male poet interspersed with images of environment

Video of spoken word poem from The Bigger Picture Project, "Bottled Up" by Eileen Torrez; images of Hispanic female poet interspersed with images of environment

Video of spoken word poem from The Bigger Picture Project, "The Corner" by Jose Vadi; images of Hispanic male poet interspersed with images of environment

Video of spoken word poem from The Bigger Picture Project, "Thin Line" by Ivori Holson; images of African-American female poet interspersed with images of environment

Spoken word poems set to images performed by youth who wrote the poems. Videos were produced by The Bigger Project and were posted publicly to the Bigger Picture Project website and YouTube. Duration of videos ranges from 2 minutes to 6 minutes.

Health Communication

A randomized controlled trial to test the effects of culturally appropriate nutrition communication for Mexican American women.

An unbalanced randomized controlled trial with pre-test and immediate post-test was employed to test the effects of different types of message features and appeals. The study was conducted online with Mexican American women aged 18-29 years old. Messages focused on sugary beverage consumption and the main outcomes were acceptance and receptivity to the message (i.e., perceived effectiveness), perceptions of social norms, and knowledge. The investigators also measured a number of hypothesized mediators and moderators of the effects.

Culturally Appropriate Nutrition Communication for Mexican American Women

Culturally Appropriate Nutrition Communication for Mexican American Women: A Randomized Controlled Trial

Perceived effectiveness of the message is known to affect intention to engage in a given health behavior. Therefore, perceived effectiveness of the stimuli was assessed as a proxy measure for intention to reduce sugary beverage consumption using a 5-point, 13-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. This scale comprised 3 subscales namely (1) Message Acceptance - 2 items, (2) Argument Strength - 4 items, (3) Personalized Perceived Effectiveness - 7 items. Greater scores on this scale represented greater levels of perceived effectiveness of the message.

responses ranging from Strongly Agree=5 to Strongly Disagree=1. Two sample items from the scale are, "During viewing, I felt I could really get inside the person's head", and "At key moments in the video, I felt I knew exactly what they were going through". Greater scores on this scale represent greater degree of identification with the character in the video.

Activation of social justice values was measured using a 5-point, 2-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. The two items are, "The message made me think that when I choose to eat healthy, I'm helping to make the world a better place" and "The message made me think that when I eat healthy, I'm doing my part to protect people who are being manipulated by sugary beverage companies". Greater scores on this scale represent greater levels of activation of social justice values.

Sugary beverage related media literacy was measured using a 5-point, 8-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. This scale measured how much the participants understood the ways in which sugary beverage industry used media to influence and manipulate their sugary beverage consumption behaviors. Some sample items are as follows: "Certain sugary drink brands are designed to appeal to people like me", "Sugary drink ads show a healthy lifestyle to make people forget about the health risks, such as weight gain and diabetes" and "Sugary drink ads link drinking these beverages to things people want, like love, good looks, and power". Greater scores on this scale represent greater levels of sugary beverage media literacy.

Public health literacy is defined here as an understanding of the social determinants of health. This was measured using a 5-point and 7-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. The seven items measured opinions about how much different external factors affect health because these best reflected an understanding of the social determinants of health: (1) money, (2) education, (3) safe and affordable housing, (4) early childhood experiences, and (5) government policies and programs (6) lifestyle choices and (7) consequences of system failure on the under-resourced. Greater scores on this scale represented greater levels of public health literacy.

Empowerment to engage in civic action was measured using a two-item index that assessed the perceived effectiveness of engaging in civic actions. Each question was a 4-point Likert item with responses ranging from "Very Effective=4" to "Very Ineffective=1". The two items were as follows, "How effective would it be to boycott sugary beverages as a way to convince corporations to stop pushing sugar to my community?" and "How effective would it be to use social media to convince corporations to stop pushing sugar to vulnerable groups?". Greater scores on this index represented greater levels of efficacy to engage in civic action.

Knowledge increases self-efficacy and empowers people to make better health choices for themselves and knowledge of the negative consequences of a given health behavior increases the intention to reduce that behavior. Therefore, better knowledge of the negative consequences of sugary beverage consumption directly impacts both individual level sugary beverage consumption as well as social level psychological empowerment to advocate for reduction in sugary beverage consumption at the community level. A sugary beverage knowledge scale comprised 6 true or false items adapted from multiple studies. The statements were as follows: Excessive sugar consumption causes, (1) health problems (2) weight gain (3) dental caries (4) diabetes (5) cancer and (6) heart disease". Greater scores on this scale represented greater levels of sugary beverage knowledge.

Engagement with the message was assessed with 2 items from the Narrative Transportation Scale (Green et al.).

Perceived similarity of the participant with the main character (poet/speaker) in the video was assessed with a 2-item scale adapted from Cohen and colleagues (2018).

Elaboration of the message arguments was assessed using a 4-point scale created by Kahlor and colleagues (2003) and a 3-point sugar-specific elaboration scale created by Dixon and colleagues (2015).

National Cancer Institute (NCI)

University of California, Merced

Associate Professor

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Lung Neoplasms

Pancreatic Neoplasms

Anorexia

Head and Neck Neoplasms

Pancreatic Cancer

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Analgesics

Psychotropic Drugs

Dexamethasone

Dexamethasone acetate

Dronabinol

Mirtazapine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antidepressive Agents

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Anti-Anxiety Agents

Adrenergic Agents

Adrenergic alpha-2 Receptor Antagonists

Adrenergic alpha-Antagonists

Adrenergic Antagonists

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Hallucinogens

Analgesics, Non-Narcotic

The patients with fair-good appetite (score on CNAQ more than 24) will not receive any pharmacological agents and will receive nutrition intervention alone.

CNAQ = Council on Nutrition Appetite Questionnaire

The patients with poor-fair appetite (score on CNAQ less than 24) will be provided nutrition intervention by the Registered Dietitian and then put into one of three pharmacological groups.

CNAQ = Council on Nutrition Appetite Questionnaire

If the patient's prognosis is extremely poor (less than 12 weeks expected survival, based on discussion with the patient's treating physicians) and there is no additional disease modifying therapy planned, the patient will be prescribed 4mg dexamethasone (which is FDA approved), once daily, to be taken orally in the morning.

If the patient has a history of marijuana use or has tried it in the past and had a positive experience with it, then the patient will be prescribed dronabinol (which is FDA approved) 2.5mg, twice daily before meals.

If the patient does not have any history of marijuana use, mirtazapine will be prescribed. If the patient is under the age of 70, then the patient would be prescribed 15mg of mirtazapine (which is FDA approved), once daily, to be taken orally at bedtime. For geriatric population (if the patient is over the age of 70), then the patient would be prescribed 7.5mg of mirtazapine, once daily to be taken orally at bedtime.

Nutrition intervention will be in accordance with the Academy of Nutrition and Dietetics guidelines. The intervention will involve "purposefully planned action(s) designed with the intent of changing a nutrition-related behavior, risk factor, environmental condition, or aspect of health status

Nutrition Intervention

Justin Tang, MD

Loss of appetite is a common symptom of patients with cancer and can cause distress which impacts patients and caregivers. Patients diagnosed with head/neck, lung or pancreatic cancer will be recruited for this study to decrease the suffering and distress associated with eating during cancer treatment and improve the quality of life of patients by implementing an algorithm utilizing nutrition intervention and appetite stimulants.

Nutrition and Pharmacological Algorithm for Oncology Patients Study

Assessing Quality of Life and the Feasibility of a Nutrition and Pharmacological Algorithm for Oncology Patients With Anorexia

The primary outcome of this study is assessing the impact on quality of life for the oncology patients by using an algorithm for nutrition intervention and appetite stimulants through utilizing Functional Assessment of Cancer Therapy-General Population (FACT-GP).

The secondary outcome of this study is assessing the impact on quality of life/appetite for the oncology patients by using an algorithm for nutrition intervention and appetite stimulants through utilizing the Council of Nutrition appetite questionnaire.

Montefiore Medical Center

This was not a therapeutic trial and as such regular review of study conduct, adverse events, and results by a Data and Safety Monitoring Board (DSMB) was not required, and deaths, serious adverse events, and nonserious adverse events were not assessed for planned study participants. As noted only one participant was enrolled into the study.

The patients with fair-good appetite (score on CNAQ \> 24) will not receive any pharmacological agents and will receive nutrition intervention alone.

Nutrition Intervention: Nutrition intervention will be in accordance with the Academy of Nutrition and Dietetics guidelines. The intervention will involve "purposefully planned action(s) designed with the intent of changing a nutrition-related behavior, risk factor, environmental condition, or aspect of health status

Patients With Fair to Good Appetite

The patients with poor-fair appetite (score on CNAQ \< 24) will be provided nutrition intervention by the Registered Dietitian and then put into one of three pharmacological groups.

Dexamethasone: If the patient's prognosis is extremely poor (\<12 weeks expected survival, based on discussion with the patient's treating physicians) and there is no additional disease modifying therapy planned, the patient will be prescribed 4mg dexamethasone (FDA approved), once daily, to be taken orally in the morning.

Dronabinol: If the patient has a history of marijuana use or has tried it in the past and had a positive experience with it, then the patient will be prescribed dronabinol (FDA approved) 2.5mg, twice daily before meals.

Mirtazapine: If the patient does not have any history of marijuana use, mirtazapine will be prescribed. If the patient is under the age of 70, then the patient would be prescribed 15mg of mirtazapine (FDA approved), once daily, to be taken orally at bedtime. For geriatric population (if the patient is over the age of 70), then the patient would be prescribed 7.5mg of mirtazapine, once daily to be taken orally at bedtime.

Nutrition Intervention: Nutrition intervention will be in accordance with the Academy of Nutrition and Dietetics guidelines. The intervention will involve "purposefully planned action(s) designed with the intent of changing a nutrition-related behavior, risk factor, environmental condition, or aspect of health status

Patients With Poor to Fair Appetite

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Only 1 participant was enrolled in this study.

The primary and secondary outcomes were unable to be assessed as only 1 patient (out of a planned 30) was enrolled into the study. No analyses were therefore conducted.

Dr. Justin Tang

Only 1 patient was enrolled into the study prior to termination. This patient was enrolled into the 'Patients with poor to fair appetite' arm based on their CNAQ score. Data were not collected.

Quality of Life Assessment

Quality of Life/Appetite Assessment

The patients with fair-good appetite (score on CNAQ \> 24) will not receive any pharmacological agents and will receive nutrition intervention alone.

Nutrition Intervention: Nutrition intervention will be in accordance with the Academy of Nutrition and Dietetics guidelines. The intervention will involve "purposefully planned action(s) designed with the intent of changing a nutrition-related behavior, risk factor, environmental condition, or aspect of health status

CNAQ = Council on Nutrition Appetite Questionnaire

Patients with poor-fair appetite (score on CNAQ \< 24) will be provided nutrition intervention by the Registered Dietitian and then put into one of three pharmacological groups.

Dexamethasone: If the patient's prognosis is extremely poor (\<12 weeks expected survival, based on discussion with the patient's treating physicians) and there is no additional disease modifying therapy planned, the patient will be prescribed 4mg dexamethasone (FDA approved), once daily, to be taken orally in the morning.

Dronabinol: If the patient has a history of marijuana use or has tried it in the past and had a positive experience with it, then the patient will be prescribed dronabinol (FDA approved) 2.5mg, twice daily before meals.

Mirtazapine: If the patient does not have any history of marijuana use, mirtazapine will be prescribed. If the patient is under the age of 70, then the patient would be prescribed 15mg of mirtazapine (FDA approved), once daily, to be taken orally at bedtime. For geriatric population (if the patient is over the age of 70), then the patient would be prescribed 7.5mg of mirtazapine, once daily to be taken orally at bedtime.

Nutrition Intervention: Nutrition intervention will be in accordance with the Academy of Nutrition and Dietetics guidelines. The intervention will involve "purposefully planned action(s) designed with the intent of changing a nutrition-related behavior, risk factor, environmental condition, or aspect of health status

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design	NCT06250166	Colorectal Canc... Nutrition Poor Gastrointestina... Quality of Life	iPLANT diet pla... Usual diet coun...	18 Years -	National Cancer Institute, Malaysia
Culturally Appropriate Nutrition Communication for Mexican American Women	NCT04352530	Lifestyle Risk ... Nutrition Poor Chronic Disease Obesity Cancer, Breast	Health Communic...	18 Years - 29 Years	University of California, Merced
Culturally Appropriate Nutrition Communication for Mexican American Women	NCT04352530	Lifestyle Risk ... Nutrition Poor Chronic Disease Obesity Cancer, Breast	Health Communic...	18 Years - 29 Years	University of California, Merced
Nutrition and Pharmacological Algorithm for Oncology Patients Study	NCT04155008	Oncologic Compl... Quality of Life Nutrition Poor Head and Neck C... Lung Cancer Pancreatic Canc...	Dexamethasone Dronabinol Mirtazapine Nutrition Inter...	18 Years -	Montefiore Medical Center
Culturally Appropriate Nutrition Communication for Mexican American Women	NCT04352530	Lifestyle Risk ... Nutrition Poor Chronic Disease Obesity Cancer, Breast	Health Communic...	18 Years - 29 Years	University of California, Merced
Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design	NCT06250166	Colorectal Canc... Nutrition Poor Gastrointestina... Quality of Life	iPLANT diet pla... Usual diet coun...	18 Years -	National Cancer Institute, Malaysia

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