Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Amino Acids

Androgens

Hormones

Hormone Antagonists

Arginine

Glutamine

Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

Standard of care androgen deprivation therapy

1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months

Standard of care ADT + (HMB + arginine + glutamine)

Patient will receive standard of care androgen deprivation therapy (ADT) alone

Standard of care ADT

Kathryn Bylow, MD

This is a study of HMB plus amino acids in older men with prostate cancer starting androgen deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional supplementation will decrease the loss of muscle mass and strength that occurs when men start ADT.

It is well established that older patients experience age-related loss of muscle mass and function (sarcopenia), presumably due to an imbalance of protein synthesis versus protein breakdown. In addition, studies have shown that men who start on ADT experience increased muscle protein breakdown and decreased synthesis. β-hydroxy-β-methylbutyrate (HMB), a leucine metabolite, has been shown to slow protein breakdown. When HMB is given with arginine and lysine (which support protein synthesis) in randomized trials, researchers have shown that elderly men and women who receive this nutritional supplementation experience improvement in fat-free mass, strength, functionality and protein synthesis when compared with controls. In addition, patients with advanced cancer who experienced weight loss of at least 5% have also been shown to benefit from HMB, with supplementation resulting in a significant increase of fat-free mass when compared to controls. Thus, it seems reasonable that older men with prostate cancer starting on ADT who experience lean muscle loss as a result of aging and ADT, may achieve some benefit from supplementation with HMB as well. Use of HMB in men with prostate cancer has not been reported.

Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation

Use of β-hydroxy-β-methylbutyrate to Counteract Loss of Muscle Mass and Strength in Older Men With Prostate Cancer Started on Androgen Deprivation Therapy

This measure will be the change of lean body mass from baseline reported in kilograms.

Cross-sectional area of the dorsiflexor muscle will be measured in mm\^2 using magnetic resonance imaging. The dorsiflexor muscles at the front of the leg are responsible for lifting the ball of the foot with the heel in contact with the ground. One dorsiflexor muscle in one leg was analyzed per participant.

Dorsiflexor muscle strength in kilograms will be measured with a custom lower leg ergometer. The dorsiflexor muscles at the front of the leg are responsible for lifting the ball of the foot with the heel in contact with the ground.

The SPPB uses Likert-style ratings for balance, walking speed, and standing test (Guralnik, 2000).

Balance metric is the ability to hold three standing positions (feet side-by-side; side of the heel of one foot touching the big toe of the other foot; heel of one foot in front of and touching the toes of the other) up to 10 seconds. Inability to hold a position scores '0'. The sum of scores is the Balance Score. Scoring range is 0-4. Higher scores indicate better balance.

Walking metric is time to walk 8 feet. Faster times score more points. Inability to complete the walk scores '0'. The score range is 0-4. Higher scores indicate better mobility.

The Standing Test. The subject is asked to stand and sit five times as quickly as possible. Inability to complete five repetitions scores '0'. Shorter times score more points. Scoring range is 0-4. Higher scores indicate better mobility.

Overall score is the sum of the scores ranging 0 to 12. Higher scores indicate better performance.

This measure will be the change in the number of reported falls from baseline (defined as the 3 months preceding the baseline visit), and the 3 month period beginning after the baseline visit and continuing through 3 months of therapy.

Medical College of Wisconsin

Associate Professor of Medicine

Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months

Standard of Care ADT + (HMB + AG)

Standard of care androgen deprivation therapy

Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone

Standard of Care ADT

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Baseline

Change from Baseline

Change From Baseline in Body Composition (Lean Body Mass)

Change at 3 months

Due to unavailability of equipment, only 5 subjects in the HMB+AG group and 8 subjects in the standard ADT therapy group completed both baseline and 3 months follow-up measurements.

Change From Baseline of Dorsiflexor Muscle Size in mm^2.

Due to unavailability of equipment, only 5 subjects in the HMB+AG group and 10 subjects in the standard ADT group completed both baseline and 3 month follo-up visits.

Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms.

3 months

Four subjects in the HMB+AG group and one subject in the standard ADT group did not complete the SPPB test at the 3-month follow-up.

Physical Performance Measured Using the Short Physical Performance Battery (SPPB)

Three subjects in the HMB+AG group did not report the number of falls at the 3-month follow-up.

Change From Baseline in the Number of Fall Events

Overall Study

Other Dietary Supplements

Whey Protein

Patients undergo total body high-intensity RT thrice weekly and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks.

Patients undergo total body RT and stretching as in Arm I.

Patients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT. After 12 weeks, patients may undergo the RT program as in Arm I.

Patients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I.

exercise intervention

nutritional supplementation

quality-of-life assessment

questionnaire administration

pharmacological study

laboratory biomarker analysis

E. Todd Schroeder

This randomized pilot clinical trial studies resistance training and protein supplementation in increasing lean body mass in patients with prostate cancer receiving androgen deprivation therapy. Resistance training and protein supplementation may help improve quality of life in patients with prostate cancer receiving androgen deprivation therapy.

PRIMARY OBJECTIVES:

I. To examine the effects of progressive, structured resistance training (RT) program , with and without protein supplementation (PS), on lean body mass (LBM) in prostate cancer survivors (PCS) on androgen deprivation therapy (ADT). Increases in LBM may influence additional outcomes such as physical function, quality of life (QOL) and molecular pathways that regulate skeletal muscle.

SECONDARY OBJECTIVES:

I. To examine the effects of a structured RT program, with and without PS, on muscle strength, physical function, and QOL in PCS on ADT .

TERTIARY OBJECTIVES:

I. To examine the effects of a progressive, structured RT program, with and without PS, on anabolic and catabolic molecular regulators of skeletal muscle in PCS on ADT.

II. To examine the effects of a progressive, structured RT program, with and without PS, on bone turnover markers and bone mineral density in PCS on ADT.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I: Patients undergo total body high-intensity RT thrice weekly, and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks.

ARM II: Patients undergo total body RT and stretching as in Arm I.

ARM III: Patients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT. After 12 weeks, may undergo the RT program as in Arm 1.

ARM IV: Patients undergo the home flexibility program as in Arm III. After 12 weeks, patient may undergo total body RT as in Arm 1.

After completion of study treatment, patients are followed up periodically.

Resistance Training and Protein Supplementation for Prostate Cancer Survivors

Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy

Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).

Intent-to-treat models will be computed using repeated measures ANOVA.

National Cancer Institute (NCI)

University of Southern California

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

Raspberry

Patients receive BRB nectar PO BID for weeks 0-4 and then receive placebo PO BID for weeks 6-10 in the absence of unacceptable toxicity. Patients also undergo collection of nasal swabs, blood, urine, and stool samples at weeks 0, 4, 6, and 10.

Patients receive placebo PO BID for weeks 0-4 and then receive BRB nectar PO BID for weeks 6-10 in the absence of unacceptable toxicity. Patients also undergo collection of nasal swabs, blood, urine, and stool samples at weeks 0, 4, 6, and 10.

Undergo collection of nasal swabs, blood, urine, and stool

Biospecimen Collection

Nutritional Supplementation

Placebo Administration

Questionnaire Administration

Daniel Spakowicz, PhD, MS

This trial studies how well black raspberry nectar works in changing the gut microbiome and in reducing inflammatory processes that may lead to lung cancer. Studying the effects of black raspberry beverage on inflammation may help doctors find strategies to reduce the risk of developing lung cancer.

PRIMARY FEASIBILITY OBJECTIVE:

I. To evaluate the feasibility of establishing a diet intervention trial with longitudinal microbiome collection in Ohio State University Comprehensive Cancer Center (OSUCCC) Lung Cancer Screening Clinic (OSUCCC-LCSC).

PRIMARY SCIENTIFIC OBJECTIVE:

I. To determine the impact of the black raspberry (BRB) nectar intervention on the microbiome and inflammatory biomarkers.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive BRB nectar orally (PO) twice daily (BID) for weeks 0-4 and then receive placebo PO BID for weeks 6-10 in the absence of unacceptable toxicity. Patients also undergo collection of nasal swabs, blood, urine, and stool samples at weeks 0, 4, 6, and 10.

ARM II: Patients receive placebo PO BID for weeks 0-4 and then receive BRB nectar PO BID for weeks 6-10 in the absence of unacceptable toxicity. Patients also undergo collection of nasal swabs, blood, urine, and stool samples at weeks 0, 4, 6, and 10.

Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study

The BE WELL Study: Black Raspberry Beverage Working to Prevent Lung Cancer

Recruitment rates will be defined as the proportion of screened accrued relative to those approached. Successful recruitment rates will be defined as \>= 10% of participants approached agree to participate.

Study adherence will be defined as the percent of the biospecimens collected at the end of the study period, with a compliance goal of 60%. Will track the monthly collection of data and document reasons for missing any scheduled collection dates. The proportions of missing information at each time point will be calculated. Descriptive statistics will examine the distribution of all patient and treatment characteristics, overall and by patient and disease characteristics.

Evaluated by ribonucleic acid sequencing.

Evaluated by metagenomic whole sequencing.

Samples of urine, stool. and blood will be analyzed for BRB phytochemicals (ellagitannins, ellagic acid, quercetin glycosides, anthocyanins) and their metabolites (urolithins, quercetin glucuronides/sulfates, methylated anthocyanins).

Ohio State University Comprehensive Cancer Center

Principal Investigator

Digestive System Diseases

Mouth and Tooth Diseases

Mucositis

Esophagitis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Esophageal Diseases

Patients receive 10 different nutrition supplements PO and complete questionnaires based on each sample in a single session over 60-90 minutes.

Salma Jabbour

This pilot clinical trial studies sensory evaluation of oral nutrition supplements in patients at risk for mucositis undergoing cancer treatment. Sensory evaluation may help to obtain input about new oral nutritional supplements that may increase nutrient intake and maintain or improve nutritional status, functional capacity, and quality of life in cancer patients.

PRIMARY OBJECTIVES:

I. To identify two products (one from the creamy shake category and one from the tea category) with the highest total average score that will be selected to move onto further testing.

OUTLINE:

Patients receive 10 different nutrition supplements orally (PO) and complete questionnaires based on each sample in a single session over 60-90 minutes.

Sensory Evaluation of Oral Nutrition Supplements in Patients at Risk for Mucositis Undergoing Cancer Treatment

Sensory Evaluation of a New Oral Nutrition Supplement in Patients at Risk for Mucositis

Will identify one product from the creamy shake category with the highest total average score that will be selected to move onto further testing. The subjective assessments of each formula will be assessed and mean, standard deviation and range will be calculated for each response. There will be subjective evaluation of acceptance of the overall sensory attributes and flavor liking (9-point scale), open-ended description of sensory attributes and effects (aroma, flavor, aftertaste, off-flavors), flavor intensity, sweetness (too little, just about right, too thick) 5-point scale. In-mouth sensations (cooling, tingling, mouth wetting, refreshing, soothing, wetting) 9-point scale.

Will identify one product from the tea category with the highest total average score that will be selected to move onto further testing. The subjective assessments of each formula will be assessed and mean, standard deviation and range will be calculated for each response. There will be subjective evaluation of acceptance of the overall sensory attributes and flavor liking (9-point scale), open-ended description of sensory attributes and effects (aroma, flavor, aftertaste, off-flavors), flavor intensity, sweetness (too little, just about right, too thick) 5-point scale. In-mouth sensations (Cooling, tingling, mouth wetting, refreshing, soothing, wetting) 9-point scale.

Rutgers, The State University of New Jersey

Rare Diseases

Carcinoma, Squamous Cell

Adenocarcinoma

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Esophageal Cancer

Patients receive standard of care nutritional supplementation.

Patients receive Impact Advanced Recovery PO or via feeding tube BID on days 1-7 for weeks 1, 3, and 5 during chemotherapy and radiation therapy before surgery. Starting 5-7 days before surgery, patients receive Impact Advanced Recovery PO TID until surgery. Within 2 days following surgery, patients may continue to receive Impact Advanced Recovery via feeding tube at the discretion of the treating physician.

Given standard of care nutritional supplementation

Nutritional Supplement Drink

Given Impact Advanced Recovery PO or via feeding tube

Wayne L Hofstetter

This phase III trial studies nutritional supplementation with Impact Advanced Recovery to see how well it works compared with standard nutritional supplementation in reducing complications in patients with esophageal cancer that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing chemotherapy, radiation therapy, and/or surgery. Impact Advanced Recovery may help to reduce the number of surgical complications, reduce toxicity, improve nutritional status before surgery, and reduce morbidity after surgery in patients with esophageal cancer.

PRIMARY OBJECTIVES:

I. When compared to the current standard of ad hoc nutritional supplementation on an as-needed basis, scheduled enteral supplementation with Impact Advanced Recovery during the course of neoadjuvant therapy (for those in the planned trimodality group), preoperatively, and postoperatively will improve patient wellbeing by reducing weight loss (measured at baseline, preoperatively, and at postoperative follow-up) incurred during the course of therapy and will permit maintenance of patient performance status.

SECONDARY OBJECTIVES:

I. Decrease rates of a composite outcome that includes anastomotic leaks, ileus, major pulmonary events (pneumonia, reintubation, tracheostomy), wound infection, postoperative mortality, chyle leaks, and other postoperative complications.

II. Improve overall survival. III. Return to pre-surgical activity level (measured by Eastern Cooperative Oncology Group \[ECOG\] at baseline, preoperatively, and at postoperative follow-up).

IV. Decrease postoperative length of stay. V. Decrease incidence of esophagitis during and after radiation therapy. VI. Improve rates of completion of all planned neoadjuvant therapies (defined as receipt of a minimum of 41.4 Gray and two cycles of chemotherapy).

VII. Improve rates of lymphopenia.

EXPLORATORY OBJECTIVES:

I. Maintain or improve serum levels of arginine, citrulline, and albumin, while maintaining or decreasing serum levels of asymmetric dimethylarginine (ADMA) and C-reactive protein.

II. Improve immune function using peripheral markers such as CD4 count, CD4:CD8 ratio, CD3 zeta, myeloid-derived suppressor cells (MDSCs), IL-6 (interleukin 6), and IL-7.

III. Increase densities of tumor-associated immune cells (TAICs; including CD3+, CD8+, CD45RO+, CD57+, CD4+, FOXP3+, granzyme B+, CD68+, PD1+ cells) within the tumor tissue.

IV. Reduce platelet-to-lymphocyte, monocyte-to-lymphocyte, and neutrophil-to-lymphocyte ratios as measured by routine clinical complete blood counts.

V. Composition of intratumoral, peritumoral, and enteric microbiome.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive standard of care nutritional supplementation.

GROUP II: Patients receive Impact Advanced Recovery PO or via feeding tube twice daily (BID) on days 1-7 for weeks 1, 3, and 5 during chemotherapy and radiation therapy before surgery. Starting 5-7 days before surgery, patients receive Impact Advanced Recovery PO three times daily (TID) until surgery. Within 2 days following surgery, patients may continue to receive Impact Advanced Recovery via feeding tube at the discretion of the treating physician.

After completion of study, patients are followed up at 24 and 30 days.

Nutritional Supplementation in Reducing Complications in Patients With Locally Advanced Esophageal Cancer Undergoing Chemotherapy, Radiation Therapy, and/or Surgery

Nutritional Supplementation for Esophageal Cancer Patients Undergoing Trimodality Therapy

Will be measured by weight loss change incurred during the course of therapy and maintenance of patient performance status. The composite outcome will be Clavien-Dindo postoperative morbidity (POM) score, which is an ordinal health quality outcome variable with six levels: 0=normal recovery, 1=minor complication, 2=complication requiring pharmaceutical intervention, 3=complication requiring surgical, endoscopic or radiological intervention, 4=life-threatening complication requiring intensive care and 5=complication leading to the patient's death. Each patient will be monitored for up to 30 days after their operation, and their POM score based on this postoperative period will be recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation	NCT01607879	Prostate Cancer	Standard of car... Standard of car...	60 Years -	Medical College of Wisconsin
Resistance Training and Protein Supplementation for Prostate Cancer Survivors	NCT01909440	Prostate Cancer	exercise interv... nutritional sup... quality-of-life... questionnaire a... pharmacological... laboratory biom...	50 Years -	University of Southern California
Resistance Training and Protein Supplementation for Prostate Cancer Survivors	NCT01909440	Prostate Cancer	exercise interv... nutritional sup... quality-of-life... questionnaire a... pharmacological... laboratory biom...	50 Years -	University of Southern California
Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study	NCT04267874	Lung Carcinoma Tobacco-Related...	Biospecimen Col... Nutritional Sup... Placebo Adminis... Questionnaire A...	55 Years - 77 Years	Ohio State University Comprehensive Cancer Center
Sensory Evaluation of Oral Nutrition Supplements in Patients at Risk for Mucositis Undergoing Cancer Treatment	NCT03228147	Esophagitis Malignant Neopl... Mucositis	Nutritional Sup... Questionnaire A...	18 Years -	Rutgers, The State University of New Jersey
Nutritional Supplementation in Reducing Complications in Patients With Locally Advanced Esophageal Cancer Undergoing Chemotherapy, Radiation Therapy, and/or Surgery	NCT04029857	Clinical Stage ... Clinical Stage ... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Resectable Mass	Nutritional Sup... Nutritional Sup...	18 Years - 80 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for nutritional supplementation