All Drugs and Chemicals

Immunomodulating Agents

Patients with stage II or III solid tumors undergoing curative intend surgery enrolled before surgery.

Patients with stage II or III solid tumors undergoing neoadjuvant therapy followed by curative intend surgery enrolled before neoadjuvant therapy.

Patients with advanced, recurrent and/or metastatic disease requiring systemic therapy with chemotherapy, targeted therapy, immunotherapy or a combination of any before initiation of any therapy or a new line of therapy following documentation of disease progression on prior therapy.

No intervention except to collect blood for diagnostic test development

Blood test

Haluk Tezcan, MD

Ayse Z Tezcan, Ph.D.

David Chan, MD

The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy treatment. More generally, this approach will allow us to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.

Blood 2 x 10 ml of Streck; FFPE tumor tissue (optional)

Detection of Tumor DNA in Blood Samples From Cancer Patients

Detection of Tumor DNA in Blood Samples From Patients With Late Stage Cancer and "Healthy Controls"

Determination of a direct correlation between the tumor load score and patient response to therapies.

To determine which particular mutation events underlie the basis of any established correlation with therapy response.

Lexent Bio, Inc.

Behaviors and Mental Disorders

All Conditions

Quality of Life

Central Nervous System Depressants

Other Dietary Supplements

Melatonin

Antioxidants

Protective Agents

Matched placebo (identical formulation and delivery, without active ingredient)

10 mg Melatonin

20 mg Melatonin

Matched placebo

Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo controlled trials have been conducted. This study evaluates the effect of melatonin in improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in patients with histologically proven advanced non small cell lung, breast, head and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT), adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.

Melatonin In Reduction of Chemotherapy-Induced Toxicity (MIRCIT) Trial

Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial

Self-reported questionnaires. FACT-L, FACT-B, FACT-H\&N and FACT-G Thai Version 4 has been previously validated. FACT-L, FACT-B, FACT-H\&N and FACT-G are used in lung, breast, head\&neck and sarcoma cancer patients, respectively. Change from baseline will be evaluated at 1,2,3 and 6 months after treatment.

8-isoprostane and 8-hydroxydeoxyguanosine urine and MDA plasma analysis

Srinagarind Hospital, Khon Kaen University

Khon Kaen Hospital, Khon Kaen

General Drugs House Co.,LTD.

Thailand Research Fund

Khon Kaen University

Associate Professor

All participants are enrolled into the intervention arm and receive the Veteran Patient Navigator and Social Work Intervention.

Each study participant will receive a veteran patient navigator intervention which consists of five study visits consisting of advance care planning, pain/symptom management, and education about hospice and palliative care. When clinically indicated, patients will be referred to a social work intervention providing psychosocial care and support.

Veteran Patient Navigator and Social Work Intervention

David Bekelman, MPH, MD

The overall goal of this study is to evaluate the feasibility of a veteran patient navigator and social work counseling intervention in veterans with advanced stage cancer at the Denver VA Medical Center. This is a tiered intervention: patients first receive the veteran patient navigator component of the intervention, and then if additional patient needs are present they receive the social work counseling component of the intervention. The overall intervention will help veterans communicate their care preferences with their providers.This is a study of behavioral and care strategy interventions and involves no investigational drugs or devices.

Many patients with advanced cancer suffer from multiple symptoms including pain and fatigue and high rates of depression and anxiety. Many also experience end of life care that is inconsistent with their preferences.

Recent studies of palliative care find that symptoms, depression, and end of life care quality improved in patients with advanced cancer with multidisciplinary, specialist palliative care compared to usual care. However, these palliative care interventions are personnel-intensive and require multiple specialist providers. Because of the costs and limited availability of specialist palliative care providers, these interventions cannot be spread to the large population of patients with advanced cancer. Thus, there is a need for scalable interventions to improve symptoms, depression, and end of life care in this patient population.

Patient navigators, who often belong to the community they serve, have improved rates of cancer screening, follow up on abnormal diagnostic tests, and adherence to chemotherapy regimens. There has been increasing recognition that palliative care is an important part of patient navigation. However, to the best of our knowledge, there have been no studies outside our research program that have examined the effects of a peer navigation intervention to improve palliative care outcomes.

While patient navigators hold promise for improving outcomes in patients with advanced cancer, both psychosocial care needs and documenting future care preferences and goals may be complex. Therefore, the proposed intervention will supplement veteran patient navigators with a social work psychosocial intervention. The goal of the proposed study is to evaluate the feasibility of a stepped care intervention including a veteran patient navigator and social worker.

Vets Helping Vets Pilot Study

The intervention will be feasible if:

A. The participation rate is above 40% and the retention rate is above 60%.

The intervention will be feasible if:

B. Oncology providers and patient participants find the intervention acceptable as defined by mean ratings of above "somewhat" useful/helpful/satisfied (i.e., above 3 on a 1 to 5 Likert scale, where 5 is "extremely" and 1 is "not at all."

The intervention will be feasible if:

C. There is less than 10% missing data on patient-reported survey measures.

A. Determine patient flow through the intervention and adherence to the study protocol by tracking:

a. number of visits

A. Determine patient flow through the intervention and adherence to the study protocol by tracking:

b. visit length

A. Determine patient flow through the intervention and adherence to the study protocol by tracking:

c problem addressed

A. Determine patient flow through the intervention and adherence to the study protocol by tracking:

d. who is seen by the social worker and why

A. Determine patient flow through the intervention and adherence to the study protocol by tracking:

e. adherence to the study protocol

B. Understand patient and oncology provider reactions through qualitative interviews to the intervention to inform how to improve feasibility or helpfulness.

VA Eastern Colorado Health Care System

Hormones

Physical fitness evaluation followed by prescribed physical activity and progress reporting.

Tailored Wii Fit prescription based on physical fitness assessments and a schedule of six home visits by an oncology RN.

Six Week Physical Activity Intervention

Participants will keep a log to record the physical activities they have done with the Wii Fit during the 6-week period. Audio-recording may be included for quality control. Self-report data will be collected by Internet surveys through the University of South Florida (USF) Health Qualtrics application at baseline (T1) and at 6 weeks post-intervention (T2). The nurse will take small amount of the participant's hair (20 strands) for a hormone test during the first visit and last visit.

Progress Reporting

Hsiao-Lan Wang, Ph.D., RN

The purpose of this study is to understand if a home-based physical activity program can improve symptoms and physical function among patients with advanced stage cancer.

This program includes use of the Nintendo Wii Fit™Plus (Wii Fit) and home visits by a nurse. The same nurse will attend all of the visits.

Physical Activity for Advanced Stage Cancer Patients

Feasibility and acceptability of a tailored Wii Fit intervention. Hypothesis1.1: 60% of eligible patients will enroll; 1.2: 60% of participants will adhere to their tailored physical activity prescriptions; 1.3: 70% of participants will agree that Wii Fit is easy to use, enjoyable, convenient, and helpful.

Enrollment rate: ratio of number of advanced stage cancer patients enrolled in the study to total number of patients meeting eligibility criteria invited to participate in the study. Adherence rate: ratio of the number of participants who adhere to the tailored Wii Fit prescription (i.e., expend at least 60% of prescribed kilocalories each week) to the total number of participants in the study. Acceptability of and satisfaction with the intervention: ratio of number of participants whose mean scores of Wii Fit and RN Visiting Surveys are equal to or more than 3 on 1-4 Likert-type scale to the total number of participants in the study.

Examine changes in outcomes (fatigue, pain, depression, anxiety, sleep quality, physical function, perceived stress, and chronic Hypothalamus-Pituitary-Adrenal (HPA) activation) over 6 weeks among patients who have the intervention. Hypothesis 2.1: There will be positive changes in the outcomes.

Repeated measures ANOVA will be used to compare T1 with T2 scores in fatigue, pain, depression, anxiety, sleep quality, physical function, perceived stress, and hair cortisol. Twenty participants will provide 80% power to detect only large effect sizes (d\>.60), which cannot be anticipated. Because the purposes of this study are to inform future larger studies, the ANOVA will be used to calculate effect sizes (η2) for future power estimations. Because effect size calculation will be the central purpose of the ANOVAs, no adjustment will be made to reduce the possibility of Type 1 errors (p\<.05).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Detection of Tumor DNA in Blood Samples From Cancer Patients	NCT02288754	Cancer Tumors	Blood test	18 Years -	Lexent Bio, Inc.
Detection of Tumor DNA in Blood Samples From Cancer Patients	NCT02288754	Cancer Tumors	Blood test	18 Years -	Lexent Bio, Inc.
Melatonin In Reduction of Chemotherapy-Induced Toxicity (MIRCIT) Trial	NCT01706627	Advanced Stage ...	10 mg Melatonin 20 mg Melatonin Matched placebo	18 Years - 70 Years	Khon Kaen University
Vets Helping Vets Pilot Study	NCT02616588	Advanced Stage ...	Veteran Patient...	18 Years - 108 Years	VA Eastern Colorado Health Care System
Physical Activity for Advanced Stage Cancer Patients	NCT02015936	Cancer	Six Week Physic... Progress Report...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Physical Activity for Advanced Stage Cancer Patients	NCT02015936	Cancer	Six Week Physic... Progress Report...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for advanced stage cancer