Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

therapeutic dietary intervention

William Aronson, MD

RATIONALE: A low-fat, high-fiber diet may slow the growth of prostate cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of a low-fat, high-fiber diet with that of a standard diet in treating patients who have prostate cancer.

OBJECTIVES:

* Compare the inhibition of growth of human prostate cancer cell lines by serum from patients with prostate cancer before and after being fed a low fat, high fiber diet.
* Determine the underlying mechanism through which a low fat, high fiber diet affects the growth of prostate cancer cell lines.
* Determine whether a low fat, high fiber diet inhibits the growth of prostate cancer cell lines through androgen-dependent and/or androgen- independent mechanisms in these patients.
* Determine the growth factors, hormones, and/or binding proteins that may be responsible for affecting the growth of prostate cancer cell lines in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 arms.

* Arm I: Patients receive a low fat, high fiber diet daily for 3 weeks.
* Arm II: Patients receive a control diet containing the standard amounts of fat and fiber.

PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within 6 months.

Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer

Effects of a Low Fat Diet on Serum Factors and Prostate Cancer

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

educational intervention

Daniel W. Nixon, MD

RATIONALE: Dietary fat may be involved in the growth of cancer cells. Restricting dietary fat may help fight cancer.

PURPOSE: Randomized clinical trial to study the effectiveness of a low fat diet in treating postmenopausal women who have stage I, stage II, or stage IIIA breast cancer that has been completely removed by surgery.

OBJECTIVES: I. Determine whether dietary fat reduction will effectively prolong disease-free and overall survival in women surgically treated for early stage breast cancer who are receiving adjuvant therapy with or without either tamoxifen, cyclophosphamide, methotrexate, fluorouracil (CMF), doxorubicin, cyclophosphamide (AC), fluorouracil, doxorubicin, cyclophosphamide (FAC, CAF), or AC followed by paclitaxel. II. Evaluate whether differences in the lipid profile are associated with dietary group assignment and dietary fat.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, nodal status, ER status, and type of adjuvant chemotherapy. The first group receives intensive dietary intervention for reduction of total fat intake to 15% of calories, with repeated individual and group counseling sessions. The second group receives USDA/DHHS dietary guidelines and minimal intervention. All patients who are estrogen receptor positive receive concurrent therapy with tamoxifen; cyclophosphamide, methotrexate, fluorouracil (CMF) followed by tamoxifen; doxorubicin, cyclophosphamide (AC) followed by tamoxifen; fluorouracil, doxorubicin, cyclophosphamide (FAC, CAF) followed by tamoxifen; or AC, paclitaxel followed by tamoxifen. Patients are followed annually throughout the study.

PROJECTED ACCRUAL: Approximately 2,500 women will be accrued for this study.

Nutrition Intervention in Treating Women With Breast Cancer

A CLINICAL TRIAL TO DETERMINE THE EFFICACY OF A DIETARY FAT REDUCTION PROGRAM PROVIDED IN ADDITION TO SYSTEMIC ADJUVANT THERAPY IN THE MANAGEMENT OF PATIENTS WITH PRIMARY INVASIVE BREAST CANCER

Institute for Cancer Prevention (IFCP)

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Hypoglycemic Agents

Gemcitabine

Metformin

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Patients receive gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15. Patients also receive metformin hydrochloride PO BID starting day -6 and dietary supplement PO BID starting day -3. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Gemcitabine Hydrochloride

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Metformin Hydrochloride

Therapeutic Dietary Intervention

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Vincent Chung

This pilot phase I trial studies the side effects of gemcitabine hydrochloride, nab-paclitaxel, metformin hydrochloride, and a standardized dietary supplement in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride, used for diabetes, may also help kill cancer cells. Dietary supplements (curcumin, vitamin D, vitamin K2, vitamin K1, B-6, high selenium broccoli sprouts, epigallocatechin gallate, L-carnitine, garlic extract, genistein, zinc amino chelate, mixed toxopherols, ascorbic acid, D-limonene) can block different targets in the cancer cell simultaneously and may slow down cancer growth. Giving gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, and metformin hydrochloride with a dietary supplement may work better in treating patients with pancreatic cancer that cannot be removed by surgery.

PRIMARY OBJECTIVES:

I. To assess the compliance, toxicity and feasibility of administering gemcitabine hydrochloride (gemcitabine), nab-paclitaxel (abraxane), metformin hydrochloride (metformin), and the dietary supplement (DS).

SECONDARY OBJECTIVES:

I. To assess the response rate associated with this combination therapy in pancreatic cancer patients.

II. To assess the progression-free survival and overall survival of all patients who start protocol therapy, and describe the outcomes based on measures of compliance during the lead-in week, and compliance with supplement during chemotherapy.

III. To collect and analyze peripheral blood and pre-treatment biopsy samples for an exploratory analysis of biological correlatives.

IV. To assess quality of life utilizing the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire.

OUTLINE:

Patients receive gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) on days 1, 8, and 15. Patients also receive metformin hydrochloride orally (PO) twice daily (BID) starting day -6 and dietary supplement PO BID starting day -3. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months.

Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery

A Pilot Study of Gemcitabine, Abraxane, Metformin and a Standardized Dietary Supplement (DS) in Patients With Unresectable Pancreatic Cancer

Peripheral blood will be evaluated. Standard descriptive methods will be used to summarize the baseline levels and the changes from baseline (i.e. after treatment) in order to examine whether observed patterns are consistent with hypothesized patterns.

Standard descriptive methods will be used to summarize the baseline levels and the changes from baseline (i.e. after treatment) in order to examine whether observed patterns are consistent with hypothesized patterns.

Feasibility is defined at 1 or fewer patients experiencing a dose limiting toxicity within the first 6 patients.

The percent of patients who are fully compliant in the first week will be estimated with a 95% confidence interval. The compliance will be measured similarly for each course prior to study treatment discontinuation. The impact of less than full compliance (both during the lead-in period and during chemotherapy) on the biomarkers and outcome, and qualitatively study patient reasons and specific supplement patterns related to non-compliance will be explored.

Summarized using the National Cancer Institute Common Terminology for Adverse Events criteria version 4. Tables will summarize the highest grade per patient that is possibly related to treatment, and the number of patients requiring dose modifications will also be presented.

Evaluated using the Kaplan-Meier methods.

City of Hope Medical Center

Skin Neoplasms

Patients receive oral GRAS supplements daily for 12 months or as possible within the patient's parameters.

laboratory biomarker analysis

Richard E. Lasker, PhD

RATIONALE: Plant extracted natural compounds, in an adjunct therapy position, slow the growth and reproduction of Stage IV Breast Cancer tumor cells. May help eradicate different types of cancers.

PURPOSE: The purpose of this randomized Phase I trial is to first IDENTIFY, through laboratory analysis and validating cellular biochemical pathways, and HELP CONTROL, using natural plant extracted compounds, G.R.A.S. (Generally Accepted As Safe), compounds, the reproduction, growth progress and metastasis of Stage IV Breast Cancer cells. The therapy position is adjunct to conventional therapies and in "one-off" trials have been excitingly effective for long-term survival. Novel use of bioactive GRAS compounds to augment and enhance conventional cancer therapies and as stand-alone parallel therapies.

OBJECTIVES:

To utilize multiple naturally-occurring bioalkaloids, bioactive "compounds of interest" from multiple sources, to influence prostate, breast, and uterine cancer pathways in cancer patients and cancer patients in remission. Other cancer types may be applicable.

To utilize specific naturally-occurring bioalkaloids and bioactive "compounds of interest" to suppress cancer proliferation-stimulation/growth activities induced by normal cancer metabolism including environmental estrogen impact, estrogen-mimicking compounds, estrogen-influencing and testosterone-type compounds.

To utilize DNA interaction with proliferating cancer cells via intercalation, which has a binding impact activity that then impairs DNA polymerase furthering DNA strand breakage and complete apoptosis. In addition, these bioactive compounds through intercalation, prevent cancer-cell DNA strand breakage from re-connection and repair, (limitlessness) while depleting nuclear topoisomerase, the enzyme also targeted by a number of conventional chemotherapy routes. Finally; a number of the bioalkaloids binds to cancer telomeres capping them at specific number or reducing them to "one and done."

Natural GRAS compounds, in previous studies that background this research, reduced secondary bonding of TMPRSS2-ERG fusing affecting testosterone \& estrogen hormone influence in cell proliferation. Variant mRNAs of, for example, the TMPRSS2-ERG fusing pathway were affected whereas normalized mRNAs in all other cells were not, a mechanism and chemistry not readily understood.

To utilize natural extracted plant compounds as a means to influence DIABLO (direct inhibitor of apoptosis binding protein with low isoelectric point) by downregulating over 350 genes which influence extracellular matrix (ECM) receptor interaction, and complement coagulation cascades were upregulated.

To utilize applications of, or ingestion of, specifically grown plant species/subspecies, extract the "compounds of action" or "compounds of activity" but maintaining an "entourage-affect by protecting "multi-compound complex arrangement chemistry" to maintain normal metabolic functionality of the compounds of interest..

BACKGROUND DATA:

Pharmaceutica has, since the turn of the 1800s to the 1900s, tried to find, extract and/or synthesize plant \& biological compounds that have the highest activity in a given medical treatment regime. In many cases the object was to get to the heart of the active compound, discarding non-active compounds,and, in other cases for various reasons including stockholder satisfaction, to be able to patent the synthesis chemistry and prevent duplication by competitors.

The one point of this important to this work is that the natural multi-compounds were the "compounds of action" for centuries and in most cases, in the natural form they were utilized in pre-20th century medicine, while the action of control was usually much slower, the side affects were non-existent.

Recent research (sic) now places a more important role of the "multi-compound" and the "entourage-effect' they have as cancer cells are quick to evolve, like viruses, and where the pharmaceutica "single compound of action" approach works well when ALL the cancer cells are eliminated, does not work well when surviving cells evolve to create resistance...a common outcome to most advanced stage cancers.

The "entourage-effect" using the "multi-compound" natural extracted compounds appears to negate the evolution/resistance response of cancerous cells by having multiple "chemistries of action" involved the cancer-control process which then hides/disguises the metabolic pathway of control from the surviving cancer cells.

OUTLINE: Patients are randomized to 1 of 2 arms.

Arm I: Patients receive oral natural supplements comprising indole-3-carbinol, perillyl alcohol, glucuronic acid, and flavonoids daily for 12 months. Patients also consume whole foods comprising indole-3-carbinol and a diet that eliminates exogenous growth hormones.

Arm II: Patients do not receive natural supplements or consume whole foods or a special diet.

Levels of compounds of interest are measured by inductively-coupled plasma mass spectrometry, high performance liquid chromatography, gas chromatography, and matrix-assisted laser desorption/ionization time of flight mass spectrometry.

After completion of study therapy, patients are followed periodically for 6 months and monitored for a second 6 months period.

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Plant Extracted Natural Compounds Impact on Stage IV Breast Cancer Survival Time and Remission.

Stage IV Breast Cancer Gene Expression Control Using Micro-Trace and Plant Extracted Natural G.R.A.S. (Generally Accepted As Safe), Compounds in Adjunct Therapy Alongside Conventional Cancer Protocols

Using adjunct therapy to augment and increase efficacy of conventional cancer treatments

Brabant Research

Director

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Xerostomia

Deglutition Disorders

Mucositis

Laryngeal Diseases

Carcinoma, Verrucous

Esophageal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Gastroenteritis

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Laryngeal Cancer

Hypopharyngeal Cancer

Amifostine

Protective Agents

Radiation-Protective Agents

Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Patients undergo SNT and low weight resistance training (LWRT).

Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.

Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

Patients undergo low weight resistance training.

exercise intervention

amifostine trihydrate

Barbara A. Murphy, MD

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation therapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine in treating head and neck cancer.

PURPOSE: This randomized phase II trial is studying amifostine to see how well it works compared with standard care in reducing side effects in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.

OBJECTIVES:

Primary

* To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine

Secondary

* To assess the relative incidence and severity of acute and chronic xerostomia in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
* To assess the relative incidence and severity of mucositis and mucositis-related inflammation in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
* To assess the effects of dysphagia, xerostomia, and mucositis-related inflammation on nutritional, physical, and functional status

OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) and concurrent chemotherapy comprising carboplatin and paclitaxel weekly.

Patients are randomized to 1 of 2 treatment arms.

* Arm I (standard of care): Patients are further divided into 1A or 1B.

  * Arm IA: Standard of care plus standardized nutrition therapy (SNT)
  * Arm IB: Standard of care plus standardized nutrition therapy plus low weight resistance training (LWRT).
* Arm II (amifostine): Patients are further divided into 2A or 2B.

  * Arm IIA: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy
  * Arm IIB: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy plus low weight resistance training

In all arms, patients undergo swallowing function, dietary, body composition, muscle, and physical and functional performance measurements at baseline and at 1, 3, and 6 months post-therapy. Quality of life, salivary production, fatigue, and symptoms (including swallowing/eating foods, appetite, weight loss/nutrition, pain, and speech/communication) are assessed at baseline and at 1, 3, and 6 months post-therapy. Anthropometric measurements are also performed at the above time points and at mid-therapy.

Blood samples and buccal rinses are collected at baseline and at 1, 3, and 6 months post-therapy for biomarker studies and for proteomic and genomic analysis by liquid chromatography and tandem mass spectrometry.

After completion of study treatment, patients are followed at 1, 3, and 6 months.

Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia

Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia

Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment

Unstimulated and stimulated salivary production, measured in mL/minute. Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods. Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.

Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).

Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.

Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24 hour dietary recalls.

Vanderbilt-Ingram Cancer Center

Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Arm IA

Arm IB

Arm IIA

Arm IIB

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Barbara Murphy, MD

No. of patients with dysphagia grade 0

No. of patients with dysphagia grade 1

No. of patients with dysphagia grade 2

No. of patients with dysphagia grade 3

No. of patients with dysphagia grade 4

Not Accessible

Patients undergo SNT and low-weight resistance training (LWRT).

One patient (Arm 2B) did not undergo the 6-month study

Number of Patients With Each Degree of Swallowing Dysfunction

Unstimulated

Stimulated

Patients who underwent salivary testing at 6 months. The following patients were not available at 6- months for testing for salivary production: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2)

Stimulated and Unstimulated Salivary Production

No. of patients with grade 0, no mucositis

No. of patients with grade 1, mild mucositis

No of patients with grade 2, moderate mucositis

No of patients with grade 3, severe mucositis

No. of patients with grade 4, disabling mucositis

No. of patients with grade 5 mucositis, death

Participants available for 6-month follow-up oral examination. No 6-month follow-up data were available for the following numbers of patients: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2).

Number of Patients With Oral Mucositis by Grade

Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Patients undergo SNT and low weight resistance training (LWRT).

exercise intervention: Patients undergo low weight resistance training.

therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.

amifostine trihydrate: Given subcutaneously

therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

exercise intervention: Patients undergo low weight resistance training.

amifostine trihydrate: Given subcutaneously

therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Due to loss of funding, sufficient data for analysis was not collected.

Changes in the Amount and Texture of Food Consumed

Changes in the Frequency and Types of Dietary Intakes

Overall Study

Herbal and Botanical

Hormones

Soy Bean

Nutritional counseling on a low-fat, high-fiber, soy supplemented diet and behavior-based activities, such as goal-setting, contracting, and stimulus control, once weekly for 6 weeks, every 3 weeks for 33 weeks, and then at weeks 44, 48, and 52.

Observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks.

behavioral dietary intervention

dietary intervention

Richard J. Babaian, MD

RATIONALE: A low-fat, high-fiber diet that includes soy protein may prevent disease progression in patients with hormone-refractory prostate cancer. Nutrition counseling may help motivate patients to follow this diet.

PURPOSE: Randomized phase I trial to study the effectiveness of behavior-based dietary interventions, such as receiving nutrition counseling, in helping patients who have hormone-refractory prostate cancer follow a low-fat, high-fiber, soy-supplemented diet.

OBJECTIVES:

* Determine whether a behavior-based dietary intervention can motivate patients with hormone-refractory prostate cancer to adopt and maintain a dietary pattern that includes \< 20% of energy from fat, \> 25 g of fiber, and 80 g of soy protein powder.
* Compare bioavailable levels of testosterone in patients treated with a behavior-based dietary intervention vs observation only.
* Determine whether this dietary intervention decreases or stabilizes a rising serum prostate-specific antigen level in these patients.
* Determine whether this dietary intervention improves disease-specific survival, mediated by reduced bioavailable levels of testosterone, in these patients.
* Determine the impact of a positive intervention outcome on androgen receptors in patients treated with this dietary intervention.

OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are randomized to 1 of 2 treatment arms.

All patients receive nutritional counseling on a healthy diet. Patients also keep a food diary during study participation.

* Arm I (dietary intervention): Patients receive dietary intervention comprising nutritional counseling on a low-fat, high-fiber, soy supplemented diet and behavior-based activities, such as goal-setting, contracting, and stimulus control, once weekly for 6 weeks, every 3 weeks for 33 weeks, and then at weeks 44, 48, and 52. Treatment continues in the absence of disease progression or unacceptable toxicity.
* Arm II (observation): Patients undergo observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks.

PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm) will be accrued for this study.

Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer

Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer

M.D. Anderson Cancer Center

gene expression analysis

polymerase chain reaction

proteomic profiling

reverse transcriptase-polymerase chain reaction

medical chart review

questionnaire administration

psychosocial assessment and care

quality-of-life assessment

support group therapy

Peter R. Carroll, MD

RATIONALE: Learning about changes in DNA over time in patients with prostate cancer undergoing diet and lifestyle changes may help doctors learn about the long-term effects of these changes on disease progression.

PURPOSE: This clinical trial is studying nutrition and lifestyle changes in patients with previously untreated stage I or stage II prostate cancer.

OBJECTIVES:

* To measure changes in gene expression in prostate tissue core biopsy samples before and after a low-fat diet and lifestyle intervention in patients with previously untreated stage I or II adenocarcinoma of the prostate.
* To collect health information from these patients to enable better understanding of the long term impact of diet and lifestyle changes on prostate cancer progression.

OUTLINE:

* Intervention phase: Patients are placed on a comprehensive lifestyle change program comprising a low-fat vegan diet, stress management, moderate aerobic exercise, and regular participation in a support group for 3 months.
* Follow-up phase: Patients undergo core tissue biopsies at baseline and at 3 months for genomic and gene expression analysis. Insulin-like growth factor 1 (IGF-1) and selenium-binding protein 1 levels are measured by quantitative reverse transcription-polymerase chain reaction (PCR). Patients also undergo blood sample collection periodically for biomarker analysis, proteomic analysis, and for telomere length and telomerase activity analysis as measured by quantitative PCR and telomerase repeat amplification protocol (TRAP). Blood and urine samples are also collected and stored for future analysis.

Patients complete questionnaires at baseline, at 3 months, and then every 6-12 months for up to 3 years to assess dietary and lifestyle behaviors (exercise, stress management practice, and group support), quality of life, and psychological adjustment. Questionnaires include the Semi-Quantitative Food Frequency Questionnaire; the SF-36 Health Survey; the UCLA Prostate Cancer Index; the Impact of Event Scale; the Memorial Anxiety Scale for Prostate Cancer; the Post Traumatic Growth Inventory; the Mindful Attention Awareness Scale; and the Received Social Support subscale from the Berlin Social Support Scale.

Patients' medical records are reviewed every 6-12 months for up to 3 years to collect information on clinical events and biomarkers (e.g., prostate-specific antigen and Gleason score).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer	NCT00020995	Prostate Cancer	therapeutic die...	40 Years - 80 Years	National Cancer Institute (NCI)
Nutrition Intervention in Treating Women With Breast Cancer	NCT00002564	Breast Cancer	educational int... therapeutic die...	48 Years - 78 Years	National Cancer Institute (NCI)
Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery	NCT02336087	Pancreatic Aden... Unresectable Pa... Stage III Pancr... Stage IV Pancre...	Gemcitabine Hyd... Paclitaxel Albu... Metformin Hydro... Therapeutic Die... Laboratory Biom... Quality-of-Life...	18 Years -	City of Hope Medical Center
Plant Extracted Natural Compounds Impact on Stage IV Breast Cancer Survival Time and Remission.	NCT00910884	Breast Cancer	laboratory biom... therapeutic die...	18 Years - 70 Years	Brabant Research
Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia	NCT00503776	Dysphagia Head and Neck C... Mucositis Xerostomia	exercise interv... amifostine trih... therapeutic die...	21 Years -	Vanderbilt-Ingram Cancer Center
Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer	NCT00082732	Prostate Cancer	behavioral diet... dietary interve... therapeutic die...	-	M.D. Anderson Cancer Center
Nutrition and Lifestyle Changes in Patients With Previously Untreated Stage I or Stage II Prostate Cancer	NCT00739791	Prostate Cancer	exercise interv... gene expression... polymerase chai... proteomic profi... reverse transcr... laboratory biom... medical chart r... questionnaire a... psychosocial as... quality-of-life... support group t... therapeutic die...	-	University of California, San Francisco
Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer	NCT00020995	Prostate Cancer	therapeutic die...	40 Years - 80 Years	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for therapeutic dietary intervention