Treatment Trials

1,202 Clinical Trials for Various Conditions

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Chronic Loose Stools Following Right-sided Hemicolectomy for Colon Cancer and the Association With Bile Acid Malabsorption and Small Intestinal Bacterial Overgrowth Using a Novel Sampling Device
Description

The goal of this clinical research study is to learn about gastrointestinal symptoms in participants who have undergone SC or RC and their impact on the quality of life of these participants.

Conditions

Colon Cancer

A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas
Description

This study is open to adults with advanced cancer of the colon, rectum, stomach, or pancreas, that is the cancer cannot be removed by surgery or has spread. People can take part in this study if their previous treatment was not successful, or no other treatment exists. The study aims to find the highest dose for the study medicine called BI 765049 that people with advanced cancer can tolerate. Another purpose is to find the most suitable dose and best way of administration of BI 765049 for further clinical development. BI 765049 may help the immune system fight cancer. Participants receive BI 765049 at least once every 3 weeks. Participants may continue to get BI 765049 treatment as long as they benefit from treatment but no longer than 3 years. During this time, participants regularly visit the study site. The study visits include several overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. Unwanted effects are any health problems that the doctors think were caused by the study medicine or treatment. To find the highest dose of BI 765049 that participants can tolerate, researchers look at the number of participants with certain severe health problems. These are severe health problems that happen within 1 week after the first treatment with the intended dose.

Conditions

Colorectal Carcinoma, Gastric Carcinoma, Pancreatic Ductal Adenocarcinoma

Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
Description

This phase II trials evaluates how well different types of phytocannabinoids (cannabidiol \[CBD\] versus tetrahydrocannabinol \[THC\] and CBD formulation \[THC:CBD\]) work to reduce chronic chemotherapy-induced peripheral neuropathy among breast and colon cancer survivors. Chemotherapy induced peripheral neuropathy is a set of symptoms that includes pain, tingling, numbness and motor weakness caused by certain types of chemotherapy treatment. Phytocannabinoids are compounds made by the cannabis plant, such as THC and CBD, that have been found to be an effective treatment for chronic pain. Phytocannabinoids may be effective in reducing chronic chemotherapy-induced peripheral neuropathy symptoms in patients treated for breast or colon cancer.

Conditions

Breast Carcinoma, Chemotherapy-Induced Peripheral Neuropathy, Colon Carcinoma

Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors
Description

The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer.

Conditions

Breast Cancer, Colon Cancer

Evaluating Online Messages About Colon Cancer Screening
Description

The goal of the study is to determine, using a choice-based approach, what messages (pulled from various online sites) people find more and less persuasive and shareable on the topic of colorectal cancer screening. As a secondary goal, the study is interested how various information behaviors, such as people's self-reported seeking of health information and encountering of health information, demographic variables, individual difference variables, and message exposure associate with their intentions to adhere to recommended colorectal cancer screening guidelines from the National Cancer Institute. The study is interested at differences specifically among Black and White Americans of recommended screening age (45-74).

Conditions

Colonic Cancer

Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study
Description

This trial evaluates how inhalational anesthesia (drawn in through the lungs) and total intravenous anesthesia (TIVA) (through a needle in a vein in the arm) change the body's ability to recover from surgery or whether they impact the immune system immediately after surgery in patients with colon cancer. It is unknown whether these types of anesthesia change recovery from surgery or change the chances cancer comes back following surgery. This study may help researchers learn how different types of anesthesia affect recovery from colon cancer surgery.

Conditions

Colon Adenocarcinoma

Real-Time CAD for Colonic Neoplasia: A RCT
Description

This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

Conditions

Colorectal Cancer, Colorectal Neoplasms

The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer
Description

To learn if cemiplimab can help to control dMMR colon cancer.

Conditions

Colon Cancer

Phase II Open-label Trial of Neoadjuvant Immunochemotherapy for Resectable Non-metastatic Colon cancER: NICER
Description

This is a Phase II open-label trial of neoadjuvant immunochemotherapy with Atezolizumab and CAPOX followed by surgery and potentially adjuvant chemotherapy for patients with localized resectable pMMR adenocarcinoma of the colon with a target accrual of 28 patients. The investigators will explore if appropriately timed neoadjuvant CAPOX with anti-PD-L1 mAb (Atezolizumab) can be administered safely and feasibly, and that this combination will lead to improved clinical response associated with enhanced numbers of immune cells in surgically resected colon tumors. Patients will receive 4 cycles of atezolizumab in combination with 4 cycles of CAPOX (atezolizumab will be administered prior to chemotherapy) before standard of care surgical resection. Following surgery, patients still considered to be at high-risk of recurrence (per SOC guidelines) will receive further adjuvant chemotherapy (mFOLFOX6 or CAPOX), based on the discretion of the treating oncologist/investigator. Circulating tumor DNA (ctDNA) dynamic change status will be analyzed through collection of blood samples throughout different stages of the patient's neoadjuvant treatment regimen (baseline, pre-neoadjuvant therapy, mid-neoadjuvant, post-neoadjuvant therapy, and during postoperative period) as a marker of early read on efficacy. The end of the study for each patient enrolled will be at the 6 month postoperative visit. On Study Protocol: Patients will be followed up for an efficacy follow-up phase during the first 6 months after surgery (week 2 \& months 3, 6 visits). All assessments beyond the 6 month visit will be performed under standard of care surveillance office visits. Off Study Protocol: Thereafter they will enter a survival follow-up phase per standard of care protocols. Patients will be seen every 6 months starting at month 12 until month 36. All collection of research-specific assessments including whole blood, stool collection and quality of life questionnaires will be optional beyond the 6 month postop visit (months 12-36).

Conditions

Stage I Colon Cancer, Stage II Colon Cancer, Stage III Colon Cancer

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Description

The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.

Conditions

Colonic Neoplasms, Neoplasms, Colon

Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
Description

To goal of this clinical trial is to quantify the dose-response effects of aerobic exercise training compared to attention control on chemotherapy relative dose intensity in colon cancer survivors.

Conditions

Colonic Neoplasms

Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer
Description

This phase II/III trial compares treatment with encorafenib and cetuximab to usual care (patient observation) for reducing the chance of cancer recurrence after standard surgery and chemotherapy in patients with BRAF-mutated stage IIB-III colon cancer. Encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Giving encorafenib and cetuximab after standard surgery and chemotherapy may be more effective at reducing the chance of cancer recurrence compared to the usual patient observation.

Conditions

Colon Adenocarcinoma, Microsatellite Stable Colon Carcinoma, Stage IIB Colon Cancer AJCC v8, Stage IIC Colon Cancer AJCC v8, Stage III Colon Cancer AJCC v8

Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
Description

This clinical trial tests how well phytocannabinoids (cannabidiol \[CBD\] and tetrahydrocannbinol \[THC\]) work in reducing chronic chemotherapy-induced peripheral neuropathy (CIPN) in breast and colon cancer survivors. Neuropathy is the most common neurological symptom reported by cancer patients due to treatment. A variety of pharmacologic treatments have been evaluated to alleviate CIPN symptoms; however, no definitive treatment has been found to successfully treat all the symptoms of CIPN. Therefore, investigators continue to seek other possible treatment options including cannabis. Phytocannabinoids may be a particularly useful intervention for cancer patients given the limited effective treatments for CIPN. In addition, cannabis-based medicines have become tremendously popular as both cancer patients and clinicians are seeking therapies with fewer potential risks of dependency and other side effects. This trial is being done to provide cancer patients and clinicians with reliable information to help guide their use of phytocannabinoids to manage the tremendous distress and pain experienced by many cancer patients, which impacts their long-term quality of life.

Conditions

Breast Carcinoma, Chemotherapy-Induced Peripheral Neuropathy, Colon Carcinoma

Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer
Description

The primary objective is to assess and characterize the antitumor activity and safety and tolerability of adjuvant treatment with an individualized neoantigen vaccine called GRT-C901/GRT-R902 (chimpanzee adenovirus \[ChAd\] and self-amplifying messenger RNA \[samRNA\] vectors), in combination with checkpoint inhibitors. Antitumor activity will be based on molecular response in patients with colon cancer who have circulating tumor deoxyribonucleic acid (ctDNA) following surgical resection.

Conditions

Colonic Neoplasms, Colorectal Neoplasms

The Effects of Chiropractic in Adults With Colon Cancer
Description

The main objectives of this single-arm pilot trial are to investigate the feasibility of our protocol in terms of 1) recruitment, 2) adherence, 3) tolerability, 4) acceptability and 5) retention. We aim to recruit 20 participants with advanced colon cancer (stage 3-4) who will have assessments of their autonomic nervous system function, carcinoembryonic antigen (CEA) levels, and patient-reported outcomes. Thereafter, patients will be directed to a nearby field clinic to receive twice-weekly cervical assessments \& high-velocity, low-amplitude (HVLA) cervical adjustments for a period of 6 weeks. Re-assessments will be performed following 2 weeks and 6 weeks of chiropractic care.

Conditions

Colon Cancer Stage III, Colon Cancer Stage IV

Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers
Description

This is a Phase II, single arm study looking at the rate of major clinical response and non-operative management in Stage II and III colon cancer after 18 weeks (up to 6 cycles) of neoadjuvant dostarlimab.

Conditions

Colon Cancer, DMMR Colorectal Cancer

A Single Arm Phase II Study to Evaluate Treatment With Gevokizumab in Patients With Stage II/III Colon Cancer Who Are ctDNA-positive After Curative Surgery and Adjuvant Chemotherapy
Description

This study will look at the recurrence-free survival of microsatellite-stable (MSS) colon cancer in patients are ctDNA (circulating tumor DNA) positive and treated with gevokizumab.

Conditions

Colon Cancer

Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer
Description

This study tests whether a high-fiber diet based on legumes, such as dry beans, can lead to sustained reductions in obesity and colon cancer risk in persons at highest risk, namely overweight or obese, post-polypectomy patients.

Conditions

Colon Cancer, Obesity

Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis
Description

This phase II trial studies the effect of atorvastatin in treating patients with ulcerative colitis who have a dominant-negative missense P53 mutation and are at risk of developing large intestinal cancer. Patients with ulcerative colitis are known to have an increased risk of developing large intestinal cancer. Better ways to control ulcerative colitis and more knowledge about how to prevent colon cancer are needed. Atorvastatin is a drug used to lower the amount of cholesterol in the blood and to prevent stroke, heart attack, and angina (chest pain). It blocks an enzyme that helps make cholesterol in the body. It also causes an increase in the breakdown of cholesterol. The information gained from this study may help doctors learn more about atorvastatin as an agent in cancer prevention, and may help to improve public health.

Conditions

Colorectal Carcinoma, Ulcerative Colitis

COLON-MD: Colon Cancer Longitudinal Study
Description

The goal of this proposal is to identify how the composition of the gut microbiome and diet interact to impact chemotherapy-induced diarrhea incidence and severity.

Conditions

Colon Cancer

Improving Quality of Life for Colon Cancer Patients and Their Caregivers
Description

By joining this study, participants, including patients and their caregivers, will be provided useful information about colon cancer that may help alleviate anxiety surrounding treatment, improve communications with the medical team, and identify practical ways to support each other. Participating in this study will have no impact on your cancer care that participants receive from your provider. It is expected that the resources provided to participants and participants caregiver will help improve participants overall care. The study team will provide computer tablets for patients and their caregivers to use as part of the study to access information about colon cancer and how to help manage participants therapeutic care. The study team will check-in each week to provide assistance with the use of the tablets and ask the patient and their caregiver, to complete an assessment survey. As part of the surveys the study team will collect participants full name, address and phone number and some basic information about participants (e.g., age, gender and race). The study team will also collect some personal or medical information, including the stage of colon cancer and treatment received (if the participant) or your relationship to the patient if participants caregiver. The study team will also collect some information on your emotional health and views about the medical care that has been provided to date from the questionnaire. All this information will be held confidential and not forwarded to anyone outside of the study personnel. There are no activities required, except that the study team will encourage caregivers and patients to discuss and use the information provided in computer tablets to enhance their cancer care. Whether or not the participants use this information will not affect their ability to receive high-quality care from their providers. There is a slight burden of responding to the survey questions used to help us understand the useful features of this program. For this reason, the investigator has included small incentives to support the time and effort needed to complete these survey assessments. The study team hopes that this study, one of the first of its kind, will help identify the resources and methods that can be used to help patients and caregivers have a better understanding of their cancer care and provide resources that they can use to enhance the effectiveness of their therapy.

Conditions

Colon Cancer

A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers
Description

Background: Often, metastatic human papillomavirus (HPV) associated cancers cannot be cured. They also do not respond well to treatment. Some forms of colon cancer also have poor responses to treatment. Researchers want to see if a new drug treatment can help people with these types of cancers. Objective: To find a safe dose of entinostat in combination with PDS01ADC and bintrafusp alfa and to see if this treatment will cause tumors to shrink. Eligibility: Adults ages 18 and older who have cervical, oropharyngeal, anal, vulvar, vaginal, penile, squamous cell rectal, or another cancer that may be associated with HPV infection or microsatellite stable small bowel or colorectal cancer. Design: Participants will be screened with a medical history and physical exam. Their ability to do daily activities will be assessed. They may have imaging scans of the brain and/or chest, abdomen, and pelvis. They may have nuclear bone scans. They will have an electrocardiogram to test heart function. They will have blood and urine tests. They may have a tumor biopsy. Participants with skin lesions may have them photographed. Some screening tests will be repeated during the study. Treatment will be done in 28-day cycles. Participants will get bintrafusp alfa through an intravenous catheter every 2 weeks. They will get PDS01ADC as an injection under the skin every 4 weeks. They will take entinostat by mouth once a week. They will complete a medicine diary. Participants will get treatment for 2 years. They will have 1-2 follow-up visits in the 30 days after treatment ends. Then they will be contacted every 6 months to check on their health.

Conditions

Oropharyngeal Cancer, Neck Cancer, Human Papillomavirus, HPV, Anal Cancer, Cervical Cancer, Penile Cancer, Vulvar Cancer, Vaginal Cancer, Colon Cancer

Rural Colon Cancer Screening Toolkit Intervention
Description

Less than half of all positive fecal immunochemical testing (FIT)s are followed-up by colonoscopy, thus limiting the full potential of colorectal cancer (CRC) screening to reduce mortality. Given the need for coordination in order to achieve high rates of follow-up, multilevel approaches are needed. Such approaches could be particularly beneficial in communities and populations that experience cancer disparities and have fewer specialty providers, but most data focuses on large systems or urban areas. The academic-community health system collaboration is uniquely poised to address this research and service gap. The persistent poverty and health disparities in rural Southern Illinois set the stage for truly impactful research. The investigators' approach will serve as a model for multilevel interventions in rural settings, inform future work addressing other health disparities, and fill a gap in rigorous trials of CRC screening follow-up in rural areas.

Conditions

Colon Cancer Screening

Engaging Patients in Colon Cancer Screening Decisions During COVID-19
Description

The goal of the study is to examine whether a shared decision making intervention improves decision making about colon cancer screening for patients who had their colonoscopy delayed or postponed due to the COVID pandemic. Eligible patients (n=800) will be randomly assigned to either the intervention or control arm. A subset will be surveyed about 6-8 weeks post intervention to measure shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will conduct medical chart review to track receipt of colon cancer screening within 6 months. The statistician will test whether patients in the intervention arm report more shared decision making, less decisional conflict, higher intention to follow through on screening and have higher screening rates compared to those in the control arm.

Conditions

Colon Cancer

Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
Description

The purpose of CLOVER is to utilize Epic Healthy Planet to increase adherence to United States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations in adults age 50 and older.

Conditions

Colon Cancer, Lung Cancer, Tobacco Use Cessation, Obesity, Pneumonia, Bacterial, Shingles, Hepatitis C

TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer
Description

This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, 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.

Conditions

Metastatic Colorectal Carcinoma, Recurrent Colon Carcinoma, Refractory Colorectal Carcinoma, Stage IV Colon Cancer AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7

Pembrolizumab in Early Stage Colon Cancer
Description

This study will gather information on the safety and effectiveness of pembrolizumab, an immunotherapy drug. The purpose of this study is to target early stage colon cancer before it has developed resistance to immunotherapy.

Conditions

Colon Cancer

A Web-based Tailored Health Behavior Intervention for Breast and Colon Cancer Survivors (eWellness)
Description

The primary objective of this study is to compare the differences in fruits and vegetable intake and physical activity from pre- to post- study between the intervention and control groups (i.e. the difference in differences). The study involves the use of web-based educational materials over a four week period. The investigators hypothesize that those in the intervention group will show a greater increase in fruit and vegetable intake and engage in more physical activity than those randomized to the control group. Eligible breast and colorectal cancer survivors from the UNC Health Registry/Cancer Survivorship Cohort (UNC HR/CSC) will be selected, consented, and randomized to either the intervention or control group. Both groups will fill out baseline surveys. The intervention group will receive a total to 4 newsletters for 4 weeks and at the beginning of week 5, they will asked to complete the follow-up survey online. The intervention newsletters focus on increasing physical activity and healthy diets. The control group will receive 4 newsletters in the same time frame as the intervention. The focus of the control group's newsletters will be on topics relevant to cancer survivors (e.g. getting back to work after treatment, managing finances) but will not focus on physical activity or diet. All contact with participants will take place online (i.e. surveys and newsletter delivery) from the study web site.

Conditions

Nutrition, Physical Activity

Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)
Description

The purpose of this study is to learn if combination of the two drugs regorafenib and nivolumab is an effective treatment for pMMR - MSS colorectal cancer, a special type of cancer of the colon or rectum (pMMR stands for proficient Mismatch Repair; MSS stands for Microsatellite Stable) and whether it is safe for patients. Regorafenib works by blocking several different proteins involved in tumor growth. Nivolumab is an immunotherapy drug encouraging the body's own immune system to attack cancer cells. Both drugs have been approved, but not for how they are being used as combination therapy in this study. Brand name of regorafenib is Stivarga; brand name of nivolumab is Opdivo.

Conditions

Colorectal Cancer

Novel Biophotonics Methodology for Colon Cancer Screening
Description

This is a proposal to establish a Bioengineering Research Partnership (BRP). The major objective of the BRP is to refine and provide comprehensive, definitive multi-center validation of these novel methodologies for colorectal cancer (CRC) screening, thus providing a quantum leap in population screening.

Conditions

Colon Cancer