Exercise for Colorectal Cancer Side Effects
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Disqualifiers: Other cancer, Metastatic malignancy, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to find the level of aerobic exercise (AT) that is practical, is safe, and has positive effects on the body that may reduce the side effects of therapy. The study will also look at the way the body responds to exercise and whether there are differences in treatment. This will include looking at the highest treatment dose participants receive, how many people stop, delay, or reduce the treatment, and whether additional medication is needed to treat side effects of therapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment Structured Treadmill Walking, Aerobic Exercise, Treadmill Exercise for colorectal cancer side effects?
Research shows that exercise, including aerobic activities like treadmill walking, can improve physical fitness and help manage treatment-related side effects in colorectal cancer patients. Exercise has been linked to better treatment completion rates and reduced toxicities, such as nausea and neurotoxicity, which are common side effects of cancer treatments.12345
Is treadmill walking safe for humans?
How does exercise differ from other treatments for colorectal cancer side effects?
Exercise is unique because it not only helps improve physical fitness and quality of life for colorectal cancer survivors, but it also potentially reduces cancer cell growth and recurrence risk through mechanisms like inflammatory pathways. Unlike traditional treatments, exercise offers a non-invasive way to manage side effects and improve overall health.1231112
Eligibility Criteria
This trial is for adults over 18 with locally advanced rectal cancer who do less than 90 minutes of moderate to strenuous exercise weekly. They must be scheduled for TNT (total neoadjuvant therapy) and cleared for exercise. People can't join if they're in another study, have distant metastatic cancer, are treated for another invasive cancer, or have mental impairments.Inclusion Criteria
Willingness to comply with all study-related procedures
Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire
Performing ≤90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
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Exclusion Criteria
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
My cancer has spread to distant parts of my body.
Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive aerobic training (AT) during neoadjuvant chemotherapy, with individualized walking sessions up to 7 times per week.
Duration of chemotherapy treatment
Supervised sessions monitored using TeleEx
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of side effects and treatment adherence.
5 years
Treatment Details
Interventions
- Structured Treadmill Walking (Behavioral Intervention)
Trial OverviewThe study tests the effects of structured treadmill walking as a form of aerobic exercise on reducing side effects from colorectal cancer treatment. It aims to determine a safe and practical level of activity that improves treatment responses and reduces the need for additional medication.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: 90 min/wkExperimental Treatment1 Intervention
AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx.
Group II: 300 mins/wkExperimental Treatment1 Intervention
AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx.
Group III: 150 mins/wkExperimental Treatment1 Intervention
AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, NJ
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Commack, NY
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, NJ
Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Acute high intensity interval exercise reduces colon cancer cell growth. [2020]Physical activity is associated with reduced mortality rates for survivors of colorectal cancer. Acute high intensity interval exercise (HIIE) reduced colon cancer cell number in vitro and promoted increases in inflammatory cytokines immediately following exercise. This acute suppression of colon cancer cell number was transient and not observed at 120 minutes post-acute HIIE. The acute effects of exercise may constitute an important mechanism by which exercise can influence colorectal cancer outcomes.
Factors Influencing Amount of Weekly Exercise Time in Colorectal Cancer Survivors. [2018]Performing regular exercise of at least 150 minutes weekly has benefits for colorectal cancer survivors. However, barriers inhibit these survivors from performing regular exercise.
A systematic review and meta-analysis of exercise interventions for colorectal cancer patients. [2022]The aim of this systematic review and meta-analysis was to investigate the effectiveness of exercise for colorectal cancer patients. PubMed/Medline, Scopus and the Cochrane Library were searched through December 2012 without language restrictions. Randomised controlled trials (RCTs) comparing exercise interventions to control conditions were analysed when they assessed health-related quality of life, fatigue, physical fitness, survival and/or tumour-associated biomarkers in colorectal cancer patients. Risk of bias was assessed using the risk of bias tool recommended by the Cochrane Back Review Group. Literature search identified 342 non-duplicate records of which five RCTs with a total of 238 patients were included; three RCTs had low risk of bias. No evidence was found for short-term effects on quality of life [standardised mean difference (SMD) = 0.18; 95% confidence interval (CI) -0.39, 0.76; P = 0.53] or fatigue (SMD = 0.18; 95% CI -0.22, 0.59; P = 0.38). There was strong evidence for short-term improvements of physical fitness after aerobic exercise compared with controls (SMD = 0.59; 95% CI 0.25, 0.93; P
The influence of high-intensity compared with moderate-intensity exercise training on cardiorespiratory fitness and body composition in colorectal cancer survivors: a randomised controlled trial. [2022]Following colorectal cancer diagnosis and anti-cancer therapy, declines in cardiorespiratory fitness and body composition lead to significant increases in morbidity and mortality. There is increasing interest within the field of exercise oncology surrounding potential strategies to remediate these adverse outcomes. This study compared 4 weeks of moderate-intensity exercise (MIE) and high-intensity exercise (HIE) training on peak oxygen consumption (V̇O2peak) and body composition in colorectal cancer survivors.
Exercise during adjuvant treatment for colorectal cancer: treatment completion, treatment-related toxicities, body composition, and serum level of adipokines. [2020]Objectives: The primary aim of this study was to investigate the beneficial effect of exercise on completion rates of adjuvant treatment, which is one of the major prognostic factors among patients with locally advanced colorectal cancer after undergoing curative resection followed by adjuvant treatment. Design: Prospective pilot study Methods: We assigned patients who were scheduled to undergo adjuvant treatment (N=39) to the exercise group or the control group in a 2:1 ratio in the order of enrollment. Patients completed questionnaires and underwent assessment of the outcome variables at the start of chemotherapy and upon completion of treatment. Results: A fivefold lower possibility of dose adjustment in the exercise group compared to the control group was demonstrated (OR, 0.188; p=0.023; 95% CI, 0.044-0.793). A significantly smaller proportion of the exercise group had grade 3 or 4 nausea (p=0.018) and neurotoxicity (P=0.024) symptoms. Muscle to fat ratios were significantly reduced in the control group (p=0.039), but not in the exercise group (p=0.742). Serum levels of leptin were significantly increased in the control group (p=0.038), but not in the exercise group (p=0.073). Serum levels of adiponectin were significantly increased in the exercise group (p=0.026) but tended to be decreased in the control group with no statistical significance (p=0.418). Conclusions: Exercise training among patients with colorectal cancer was found to have a beneficial impact on adjuvant treatment completion rates and treatment-associated toxicities. This program was also shown to be beneficial to patients' body compositions and serum levels of adipokines.
Efficacy of moderate-intensity walking provided feedback by ECE PEDO on abdominal fat in overweight and obese women: A randomized, exercise study. [2022]The aim of this study was to investigate the effectiveness of walking with Equipment for Clever Exercise (ECE PEDO) compared to supervised, moderate-intensity, aerobic, treadmill walking exercise in overweight and obese women.
The energetic and cardiovascular response to treadmill walking and cycle ergometer exercise in obese women. [2022]Physical activity is essential in obesity management, but exercise capacity is compromised in obese individuals due to the excessive body mass, impacting on body movement's energetics, and to the dysfunctions of regulatory mechanisms, affecting cardiovascular responses. This study aims to compare the energetics and cardiovascular responses of walking and cycling in obese women, and to formulate recommendations regarding the most suitable type of exercise for obesity. Fifteen obese (OB) and six normal weight (NW) women exercised on treadmill (TM) and cycle ergometer (CE). During both exercise modalities, metabolic rate was higher in OB than in NW and correlated with measures of body mass. Leg movement metabolic rate during cycling depended upon individual adiposity, and when accounted for, mechanical efficiency was similar in the two groups. When accounting for extra mass, differences in metabolic rate among groups are abolished for CE, indicating no obesity impairment of muscle efficiency, but not for TM, suggesting that differences in biomechanics may explain the higher net cost of transport of OB. In both groups, HR was higher during CE than TM at the same oxygen uptake (VO(2)), but in OB the HR increment over VO(2) was greater for CE than for TM. Therefore, due to different cardiovascular responses to TM and CE in OB, walking is more convenient, enabling OB to attain target energy expenditure at lower HR or in a shorter time.
Change in health-related quality of life and social cognitive outcomes in obese, older adults in a randomized controlled weight loss trial: Does physical activity behavior matter? [2022]This article compared the effect of dietary weight loss administered alone (WL) or in combination with aerobic training (WL + AT) or resistance training (WL + RT) on health related quality of life, walking self-efficacy, stair climb self-efficacy, and satisfaction with physical function in older adults with cardiovascular disease or the metabolic syndrome. Participants (N = 249; M age = 66.9) engaged in baseline assessments and were randomly assigned to one of three interventions, each including a 6-month intensive phase and a 12-month follow-up. Those in WL + AT and WL + RT engaged in 4 days of exercise training weekly. All participants engaged in weekly group behavioral weight loss sessions with a goal of 7-10% reduction in body weight. Participants in WL + AT and WL + RT reported better quality of life and satisfaction with physical function at 6- and 18-months relative to WL. At month 6, WL + AT reported greater walking self-efficacy relative to WL + RT and WL, and maintained higher scores compared to WL at month 18. WL + AT and WL + RT reported greater stair climbing efficacy at month 6, and WL + RT remained significantly greater than WL at month 18. The addition of either AT or RT to WL differentially improved HRQOL and key psychosocial outcomes associated with maintenance of physical activity and weight loss. This underscores the important role of exercise in WL for older adults, and suggests health care providers should give careful consideration to exercise mode when designing interventions.
The Effects of Exclusive Walking on Lipids and Lipoproteins in Women with Overweight and Obesity: A Systematic Review and Meta-Analysis. [2022]To evaluate the effects of walking, independent of diet and weight-loss, on lipids and lipoproteins in women with overweight and obesity.
Accumulating aerobic exercise for effective weight control. [2019]To compare the effects of different patterns of regular treadmill walking and cycle ergometry on body weight, body composition, waist and hip circumferences in overweight adult Singaporean females.
Colorectal cancer survivorship: movement matters. [2021]Colorectal cancer survivorship begins at diagnosis and continues throughout life. After diagnosis, survivors face the possibility of second cancers, long-term effects of cancer treatment, and comorbid conditions. Interventions that can provide primary, secondary, and tertiary prevention in this population are important. Physical activity has been shown to decrease colon cancer incidence and recurrence risk as well as improve quality of life and noncancer health outcomes including cardiovascular fitness in colon cancer survivors. The data are less robust for rectal cancer incidence and recurrence, although improvements in quality of life and health outcomes in rectal cancer survivors are also seen. Potential mechanisms for this benefit may occur through inflammatory or insulin-like growth factor pathways. The issues of colorectal cancer survivorship and the impact of physical activity on these issues are reviewed, with discussion of possible biologic mechanisms, barriers to physical activity intervention studies, and future research directions for physical activity in this burgeoning survivor population.
The effects of physical activity on survival in patients with colorectal cancer. [2018]Mortality from colorectal cancer has been declining over the past 20 years due to improvements in screening and treatment. Physical activity improves patient quality of life, slows functional decline, and reduces all-cause mortality. Although some patients may have difficulty participating in physical activity, clinicians should always try to incorporate exercise into a management plan for patients who have survived colorectal cancer.