Trial Summary
What is the purpose of this trial?skeletal muscle mass and function, is prevalent in up to 60% of colorectal cancer patients. This condition arises from a combination of factors such as aging, inactivity, treatment side effects, malnutrition, tumor burden, and inflammation. Given this complexity, singular interventions may not be sufficient to address sarcopenia in this group.
Creatine monohydrate, a compound vital for energy during exercise, has been extensively researched and proven safe and effective across various demographics, including older adults and clinical populations. Studies show that creatine enhances benefits from resistance training, indicating potential to counter muscle mass and function decline post-cancer treatment.
This study aims to assess the feasibilty of combining creatine supplementation with resistance training versus resistance training alone in sarcopenic colorectal cancer survivors. A randomized controlled pilot trial will compare a 10-week program of resistance exercise plus creatine (EXSUPP) with resistance exercise alone (EXPLA), each with 20 participants.
Is resistance exercise a promising treatment for colorectal cancer?Resistance exercise, also known as strength training, is a promising treatment because it can improve muscle strength, endurance, and overall physical performance. It has been shown to be safe and effective in various health conditions, enhancing quality of life and physical abilities.12346
What safety data exists for resistance exercise and creatine in cancer treatment?The studies indicate that creatine supplementation and resistance training have been explored in various cancer types, including breast, rectal, and prostate cancer. These studies suggest that creatine and resistance training can improve muscle mass and strength without significant safety concerns. Specifically, a trial in colorectal cancer patients showed creatine could help with muscle and strength, and a study in older men found no harmful metabolites from creatine and protein during resistance training.59101113
What data supports the idea that Resistance Exercise + Creatine for Colorectal Cancer is an effective treatment?The available research does not directly provide data on the effectiveness of Resistance Exercise + Creatine specifically for colorectal cancer. However, it does suggest that exercise, in general, can help improve physical fitness and muscle mass in cancer patients. For example, one study found that exercise during treatment helped maintain physical capacity and reduce fatigue in rectal cancer patients. Another study indicated that creatine might help improve muscle strength and weight in cancer patients experiencing weight loss. While these findings are promising, they do not specifically address the combination of Resistance Exercise + Creatine for colorectal cancer.7891012
Do I have to stop taking my current medications to join the trial?Yes, if you are taking medications that might alter body composition, like metformin or corticosteroids, you cannot participate in the trial.
Eligibility Criteria
This trial is for colorectal cancer survivors who have sarcopenia, a condition involving loss of muscle mass and function. Participants should be interested in a 10-week program that includes resistance exercise with or without creatine supplementation.Exclusion Criteria
I am currently undergoing treatment for my cancer.
Treatment Details
The study compares two groups: one doing resistance exercises while taking creatine (EXSUPP) and the other doing just the exercises (EXPLA). The goal is to see if adding creatine improves muscle health after cancer treatment.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Exercise + CreatineExperimental Treatment1 Intervention
3 days a week of resistance exercise for 10-weeks + 5g day of creatine monohydrate supplementation
Group II: Exercise + PlaceboPlacebo Group1 Intervention
3 days a week of resistance exercise for 10-weeks + 5g day of placebo (dextrose supplementation
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of South CarolinaColumbia, SC
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Who is running the clinical trial?
University of South CarolinaLead Sponsor
References
Effects of strength training on lactate threshold and endurance performance. [2022]To determine the effects of 12 wk of strength training on lactate threshold (LT) and endurance performance, 18 healthy untrained males between 25 and 34 yr of age were randomly assigned to either strength training (N = 10) or control (N = 8) groups. Despite no changes in treadmill VO2max or cycle peak VO2, a 33 +/- 5% increase (P less than 0.001) in cycling time to exhaustion at 75% of peak VO2 was observed following training. No significant changes in cycling time were observed in the control group. There were significant reductions in plasma lactate concentration at all relative exercise intensities ranging between 55 and 75% of peak VO2 training. The improved endurance performance was associated with a 12% increase in LT (r = 0.78, P less than 0.001). The strength training program resulted in significant improvements (P less than 0.001) of 31 +/- 5% and 35 +/- 7% in isokinetic peak torque values for leg extension and flexion, respectively, at a velocity of 30 degrees.s-1. There were also significant increases in 1-RM values of 30 +/- 4% (P less than 0.001) for leg extension, 52 +/- 6% (P less than 0.001) for leg flexion, and 20 +/- 4% (P less than 0.001) for the bench press. These findings indicate that strength training improves cycle endurance performance independently of changes in VO2max. This improved performance appears to be related to increases in LT and leg strength.
Cycling as a novel approach to resistance training increases muscle strength, power, and selected functional abilities in healthy older women. [2022]Cycling on a mechanically braked cycle ergometer was used as a novel approach to compare the effects of three different 16-wk resistance-training programs on isometric force, power output, and selected functional abilities in 31 healthy 65- to 74-yr-old women. Training was conducted three times per week. During each session, individuals of the speed group performed 8 sets of 16 pedal revolutions at 40% of the maximal resistance to complete two revolutions (2 RM); strength group performed 8 sets of 8 revolutions at 80% of 2 RM; and combination group performed 4 sets of 16 revolutions at 40% and 4 sets of 8 revolutions at 80% of 2 RM. During each set, all participants were required to pedal as fast as possible with a 2-min interval between sets. All training groups significantly increased force, power, and functional abilities (maximal treadmill walking speed, vertical jumping, and box stepping) at week 8 (in the range from 6.5 to 20.8%) with no further improvement at week 16 (except maximal treadmill walking speed), but no significant differences were observed between the three groups. The novel approach to performing both low- and high-resistance training, based on the use of a cycle ergometer, has been shown to be effective in improving strength, power, and functional abilities in a group of healthy women. Even fit older women can still improve in functional abilities. Interestingly, the "high-speed" and "low-speed" programs induced an increase in both power and strength of similar magnitude.
Recommendations for resistance exercise in cardiac rehabilitation. Recommendations of the German Federation for Cardiovascular Prevention and Rehabilitation. [2019]Aerobic endurance training has been an integral component of the international recommendations for cardiac rehabilitation for more than 30 years. Notwithstanding, only in recent years have recommendations for a dynamic resistance-training program been cautiously put forward. The perceived increased risk of cardiovascular complications related to blood pressure elevations are the primary concern with resistance training in cardiac patients; recent studies however have demonstrated that this need not be a contraindication in all cardiac patients. While blood pressure certainly may rise excessively during resistance training, the actual rise depends on a variety of controllable factors including magnitude of the isometric component, the load intensity, the amount of muscle mass involved as well as the number of repetitions and/or the load duration. Intra-arterial blood pressure measurements in cardiac patients have demonstrated that that during low-intensity resistance training [40-60% maximum voluntary contraction (MVC)] with 15-20 repetitions, only modest elevations in blood pressure are revealed, similar to those seen during moderate endurance training. When properly implemented by an experienced exercise therapist, in specific patient groups an individually tailored, medically supervised dynamic resistance training program carries no inherent higher risk for the patient than aerobic endurance training. As an adjunct to endurance training, in selected patients, resistance training can increase muscle strength and endurance, as well as positively influence cardiovascular risk factors, metabolism, cardiovascular function, psychosocial well-being and quality of life. According to present data, resistance training is however not recommended for all patient groups. The appropriate training method and correct performance are highly dependent on each patient's clinical status, cardiac stress tolerance and possible comorbidities. Most studies have used middle-aged men of average normal aerobic performance capacity and with good left-ventricular (LV) function. Data are lacking for high-risk groups, women and older patients. With the current knowledge it is reasonable to include resistance training without any restraints as part of cardiac rehabilitation programs for coronary artery disease (CAD) patients with good cardiac performance capacity (i.e., revascularised and with good myocardial function). As patients with myocardial ischaemia and/or poor left ventricular function may develop wall motion disturbances and/or severe ventricular arrhythmias during resistance exercise, the following criteria are suggested for resistance training: moderate-to-good LV function, good cardiac performance capacity [>5-6 metabolic equivalents of oxygen consumption (METS)=1.4 watt/kg body weight], no symptoms of angina pectoris or ST segment depression under continued maintenance of the medical therapy. Based on available data, this article presents recommendations for risk stratification in cardiac rehabilitation programs with respect to the implementation of dynamic resistance training. Additional recommendations for specific patient groups and detailed directions showing how to structure and implement such therapy programs are presented as well.
Resistance exercise in chronic heart failure--landmark studies and implications for practice. [2007]In patients with chronic congestive heart failure (CHF), there is a need for complementary strength training to maintain and/or increase muscle mass and strength. The challenge is how to stress peripheral muscles intensively without creating cardiovascular overload. Since the late 1990s, an increasing number of research and clinical experiments have been conducted on resistance exercise in CHF. As a result, data are now available for both acute responses during resistance exercise as well as muscular and cardiovascular adaptation to resistance training programs, based on different training methods. Study results demonstrated that dynamic resistance exercise is well tolerated in chronic stable CHF when: 1) initial contraction intensity is low, 2) small muscle groups are involved, 3) work phases are kept short, 4) a small number of repetitions per set is performed, and 5) work/rest ratio is > or = 1:2. With tolerance, contraction intensity can be increased. With resistance training programs lasting 12 weeks, maximal strength could be improved by 15 to 50%. Improvements in maximum exercise time and peak VO2 were between 10 and 18%, in relation to baseline values. In terms of these results, no differences were reported between combined resistance/ aerobic training and resistance training alone. Thus, resistance exercise can be assumed as safe as aerobic exercise in clinically stable CHF.
Low-dose creatine combined with protein during resistance training in older men. [2013]To determine whether low-dose creatine and protein supplementation during resistance training (RT; 3 d x wk(-1); 10 wk) in older men (59-77 yr) is effective for improving strength and muscle mass without producing potentially cytotoxic metabolites (formaldehyde).
Effect of short- and long-term strength exercise on cardiac oxidative stress and performance in rat. [2021]Increase in heart metabolism during severe exercise facilitates production of ROS and result in oxidative stress. Due to shortage of information, the effect of chronic strength exercise on oxidative stress and contractile function of the heart was assessed to explore the threshold for oxidative stress in this kind of exercise training. Male Wistar rats (80) were divided into two test groups exercised 1 and 3 months and two control groups without exercise. Strength exercise was carried by wearing a Canvas Jacket with weights and forced rats to lift the weights. Rats were exercised at 70% of maximum lifted weight 6 days/week, four times/day, and 12 repetitions each time. Finally, the hearts of ten rats/group were homogenized and MDA, SOD, GPX, and catalase (CAT) were determined by ELISA method. In other ten rats/group, left ventricle systolic and end diastolic pressures (LVSP and LVEDP) and contractility indices (LVDP and +dp/dt max) and relaxation velocity (-dp/dt max) were recorded. The coronary outflow was collected. Short- and long-term strength exercise increased heart weight and heart/BW ratio (P
Surgical resection of primary tumour improves aerobic performance in colorectal cancer. [2014]Colorectal cancer is the third most common cancer in the UK, with patients suffering declines in muscle mass and aerobic function. We hypothesised that tumour removal in non-metastatic colorectal cancer would lead to a restoration of lean muscle mass and increases in objective and subjective measures of aerobic performance.
The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients (The EMPOWER Trial): study protocol for a randomised controlled trial. [2023]The standard treatment pathway for locally advanced rectal cancer is neoadjuvant chemoradiotherapy (CRT) followed by surgery. Neoadjuvant CRT has been shown to decrease physical fitness, and this decrease is associated with increased post-operative morbidity. Exercise training can stimulate skeletal muscle adaptations such as increased mitochondrial content and improved oxygen uptake capacity, both of which are contributors to physical fitness. The aims of the EMPOWER trial are to assess the effects of neoadjuvant CRT and an in-hospital exercise training programme on physical fitness, health-related quality of life (HRQoL), and physical activity levels, as well as post-operative morbidity and cancer staging.
A double-blind, placebo-controlled randomized trial of creatine for the cancer anorexia/weight loss syndrome (N02C4): an Alliance trial. [2022]Multiple pilot studies, including one in colorectal cancer patients, suggest that creatine, an amino acid derivative, augments muscle, improves strength, and thereby could palliate the cancer anorexia/weight loss syndrome.
Feasibility and Preliminary Efficacy of a 10-Week Resistance and Aerobic Exercise Intervention During Neoadjuvant Chemoradiation Treatment in Rectal Cancer Patients. [2019]Neoadjuvant chemoradiation treatment (CRT) in rectal cancer patients is associated with a reduction in physical capacity, lean mass and increased fatigue. As a countermeasure to these treatment-related adverse effects, we examined the feasibility and preliminary efficacy of a 10-week exercise program during CRT.
Examining the effects of creatine supplementation in augmenting adaptations to resistance training in patients with prostate cancer undergoing androgen deprivation therapy: a randomised, double-blind, placebo-controlled trial. [2020]Creatine supplementation has consistently been demonstrated to augment adaptations in body composition, muscle strength and physical function in a variety of apparently healthy older adults and clinical populations. The effects of creatine supplementation and resistance training in individuals with cancer have yet to be investigated. This study aims to examine the effects of creatine supplementation in conjunction with resistance training on body composition, muscle strength and physical function in prostate cancer patients undergoing androgen deprivation therapy.
Does prehabilitation modify muscle mass in patients with rectal cancer undergoing neoadjuvant therapy? A subanalysis from the REx randomised controlled trial. [2023]Patients with rectal cancer who present with sarcopenia (low muscle mass) are at significantly greater risk of postoperative complications and reduction in disease-free survival. We performed a subanalysis of a randomised controlled study [the REx trial; www.isrctn.com ; 62859294] to assess the potential of prehabilitation to modify muscle mass in patients having neoadjuvant chemoradiotherapy (NACRT).
Creatine Supplementation and Resistance Training in Patients With Breast Cancer (CaRTiC Study): Protocol for a Randomized Controlled Trial. [2023]Creatine supplementation is an effective ergogenic nutrient for athletes, as well as for people starting a health or fitness program. Resistance training has previously been identified as an important method of increasing muscle mass and strength, especially in people with cancer to avoid sarcopenia. The potential of creatine supplementation for adaptations produced by resistance training in patients with cancer is still unknown. The primary aim of this study is to evaluate the effectiveness of a supervised resistance training program intervention with and without creatine supplementation in patients with breast cancer.