Clinical Trials Focused on Healthy Lifestyle

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Clinical Trial Conversations
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Research shows that a healthy lifestyle can lower your risk of getting colorectal cancer (CRC), decrease the risk of CRC coming back (recurrence), and even help prepare you for CRC surgery.

Even though we know the benefits of exercise, one thing that’s not talked about enough is exercise research – and how the CRC community can contribute to improving our understanding of exercise, and CRC prevention and disease management. 

This month, Maia and Manju are focusing on clinical trials investigating the benefits of physical activity.

What trials do you think are the most interesting for the CRC community?

Health Education Materials With/Out a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer (CHALLENGE)
Canadian Cancer Trials Group

This randomized phase III recruiting trial of 962 participants is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer. This trial includes biomarker analysis.

The Exercise And Colorectal Cancer Treatment Trial (EXACT)
Pennington Biomedical Research Center

This randomized trial will examine the biological effects of 12 weeks of moderate-intensity aerobic exercise versus wait-list control in 60 subjects who have completed standard medical therapy for CRC stage I through stage III. The primary objective is to determine if aerobic exercise can reduce systemic inflammation as measured using specific biomarkers.

Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome (AMICO)
Radboud University Medical Center/Netherlands Cancer Institute

The investigators hypothesize that exercise prevents chemotherapy dose modifications by reducing toxicity and enhancing psychological strength. This study is a three-armed trial for 228 participants comparing resistance exercise, aerobic interval exercise, and usual care in patients with metastatic CRC to select the optimal exercise prescription for preventing chemotherapy dose modifications. This study hopes to collect evidence for the effects of exercise on i) clinical outcome, ii) the optimal exercise prescription, and iii) the mechanisms that can help explain how exercise may boost benefit from chemotherapy treatment. 

Researching the Effect of Exercise on Cancer
MSK several locations

The purpose of this study for 70 participants is to explore how aerobic exercise (exercise that stimulates and strengthens the heart and lungs, and improves the body's use of oxygen) can reduce the level of ctDNA found in the blood. During the study, the highest level of exercise that is practical, is safe, and has positive effects on the body that may prevent the return of cancer (including a decrease in ctDNA levels) will be found. Each level of exercise tested will be a certain number of minutes each week. Once the best level of exercise is found, it will be tested further in a new group of participants. All participants in this study have been previously treated for breast, prostate, or CRC.

EXERCISING TOGETHER for Couples Coping With Cancer  
OHSU Knight Cancer Institute Portland, Oregon

The Exercising Together trial of 588 participants is a single-blind, parallel group, randomized controlled trial comparing three arms: Arm 1 (experimental): Exercising Together where couples perform partnered exercise in a supervised, group setting versus two comparator conditions where survivors and partners perform exercise routines separately in either a supervised group setting (Arm 2) or unsupervised at home (Arm 3). All three arms will train for a six-month period and then be followed six months later. Data will be collected at baseline, three, six and 12 months. Participants will include survivors of stage I through stage III breast, prostate, and CRC. The study outcomes include coping and physical intimacy and pain, fatigue and perceived physical function incongruence between couples.

Walking for Recovery from Surgery in Improving Quality of Life in Older Adults With Lung or Gastrointestinal Cancer and Their Family Caregivers
City of Hope Medical Center

This pilot 80-participant clinical trial studies how well Walking for Recovery from Surgery works in improving quality of life in older adults with lung or gastrointestinal cancer and their family caregivers. A walking program, such as Walking for Recovery from Surgery may help support overall well-being as a caregiver and may help improve family member or friend's recovery from surgery. Various parameters including steps, six-minute walking time and many other measures will be assessed using descriptive statistics

Project HERO: Health Empowerment & Recovery Outcomes (HERO)
Rutgers University, New Jersey

Project HERO is a 210-participant, 12-week study of the efficacy of Body Mind Training (BMT) for reducing fatigue in male cancer survivors. This three-arm randomized clinical trial will examine inflammatory biology and selected gene-expression pathways that are hypothesized to contribute to the intervention's effect. This study will establish the efficacy of 12-week BMT for reductions in fatigue (the study's primary outcome). Secondary patient-reported outcomes include quality of life changes (e.g., changes in sleep and perceived psychological distress), changes in the biomarkers of inflammation; including genome-wide transcriptional factors, and expression of fatigue-related genes. Participants are eligible if they have a previous diagnosis of a variety of cancers and live within a certain radius from the institution and are considered inactive. Patients currently receiving chemotherapy are excluded. Other exclusion and inclusion criteria are detailed in the clinicaltrials.gov listing.

ABCSG C08-Exercise II: Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer (ABCSG C08)
Austrian Breast and Colorectal Cancer Study Group

ABCSG C08 is a randomized, two-arm, multicenter trial of 788 participants to investigate the efficacy of endurance exercise following adjuvant chemotherapy in patients with CRC in participants with locally advanced CRC after adjuvant chemotherapy. The primary endpoint is disease-free survival. Secondary endpoints include relapse-free survival, overall survival, various physical activity endpoints, patient-reported outcome endpoints, etc.

Supervised Exercise for Post-surgery Colorectal Cancer Patients (POSTEx)  
UK

Participants (n=34) will undergo baseline screening before surgery and will be randomized to either normal postoperative care or a 12-week supervised exercise program composed of both an aerobic and resistance component. They will be assessed prior to surgery, which will include cardiopulmonary exercise testing to check aerobic exercise response. The assessment days will also include: muscle ultrasound (vastus lateralis) to ascertain muscle structure, blood tests, functional composite scores, and quality-of-life (qol) questionnaires. The primary outcome is anaerobic threshold change and secondary outcomes look at completion of the exercise program, changes in qol, inflammatory markers, and changes in muscle composition.

Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors

It is well-known that exercise/physical activity is associated with many benefits in patients with cancer treatments. This trial of the University of Colorado, Denver, is looking at identifying those effects and also at exploring multilevel determinants of physical activity maintenance. It is specifically designed for CRCl survivors – that is, patients with stage II, stage III, or stage IV who were treated with curative intent and are NED (have no current evidence of metastatic disease). They also need to have received chemotherapy and/or radiation therapy within the previous year.

In one arm of the trial, patients exercise in a virtual group (via Zoom) for 60 minutes, twice a week. Also, throughout the trial, patients participate in five social-cognitive theory-based discussion sessions with the group and with the group exercise instructor. The goal of these sessions is to enhance long-term physical activity behavior change. The other arm of the trial is a control group, where the patients receive the usual informational handout from the American Cancer Society describing exercise recommendations and guidelines for cancer survivors. However, at the end of the study, these control group participants will be offered compensation for participation in a community-based cancer-specific exercise program.

Impact of Aerobic Exercise on Immune Response and Side Effects of Cancer Treatments (CANEX-2)

This Canadian trial, only for stage IV CRC patients who are about to receive chemotherapy, aims to determine if the already observed effects of aerobic exercise on suppressing tumor growth and reducing cancer-related fatigue (CRF) are dependent on the intensity of that exercise.

The study will compare the effects of Moderate Intensity Continuous Exercise (MICE) versus High Intensity Interval Exercise (HIIE) (less time, with some one-minute blocks of high intensity exercise) over the immune system of metastatic CRC patients. Based on results from the field of exercise immunology, the researchers are testing the hypothesis that prescription of aerobic exercise, especially HIIE, before a session of chemotherapy could potentially represent an interesting therapeutic modality, allowing both the reduction of the CRF associated with the chemo as well as a better response to the treatment.

Improving Nutrition and Physical Activity for Colorectal Cancer Survivors (Tools To Be Fit) (TTBF)

This trial is for patients who had stage I, stage II, or stage III colon or rectal cancer and have completed their treatments, and for one support person who will participate in the study, along with the patients.

Here, physical activity is just one of the areas of intervention: The other one is nutrition.

Studies indicate that people with CRC whose nutrition and physical activity habits are consistent with the American Cancer Society's Nutrition and Physical Activity Guidelines may have longer disease-free survival. All patients receive a personal report about their current nutrition and physical activity; after that, they are assigned to diverse combinations of four different intervention components, during one year, to help them adopt recommended health behaviors: 1. Patients receive text messages; 2. Patients use digital health tool kit; 3. Patients receive health coaching sessions; 4. Support persons receive four coaching sessions.

DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease

In this clinical trial at M.D. Anderson, exercise is one of the four interventions proposed to prevent recurrence in stage II, stage III, and stage IV CRC patients who don't present evidence of disease after definitive treatment but present detectable circulating tumor DNA (ctDNA) mutation that matches mutations found in tumor tissue. The trial combines aspirin, vitamin D, and counseling to follow a plant-based diet (low saturated fat foods), and to increase recreational physical activity, during three months. After that, researchers will evaluate the status of the ctDNA, to determine if the interventions have affected the likelihood of advanced CRC coming back (recurring).

Stay Tuned for More Clinical Trials Conversations!

Once a month, Maia and Manju will spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!

You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.

Be sure to check out these Fight CRC Clinical Trials resources:

More Clinical Trial Conversations:

Clinical trials are critical to finding a cure for colorectal cancer. As an advocacy organization dedicated to supporting and empowering a community of patients, caregivers and families, Fight CRC has partnered with COLONTOWN to deliver a monthly blog series highlighting everything patients need to know about clinical trials and the best treatment options available. 

In this series, we hope to cover promising trials that are enrolling, lessons learned from past research, logistics and resources to joining a clinical trial, and provide relevant and timely updates for our colon and rectal cancer community. 

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