Oncology · Medical Literature
Examining the feasibility and preliminary effects of resistance exercise training and creatine supplementation in individuals treated for colorectal cancer.
Abstract
The purpose of this trial was to assess the feasibility, acceptability and safety of a 10-week hybrid (in-clinic and virtual) resistance exercise training RET program with or without CrM in individuals treated for colorectal cancer. Twenty-seven participants were randomized to RET plus 5 grams/day of CrM (EXSUPP; n = 13) or 5 grams/day corn-starch maltodextrin placebo (EXPLA; n = 14). RET was performed three times per week. Feasibility was assessed through recruitment, retention and fidelity (percentage of prescribed RET and supplementation completed). Acceptability was evaluated using a 5-point Likert scale, and safety was monitored through adverse event reporting. Secondary outcomes (body composition, muscular strength, physical function) were assessed pre- and post-intervention using baseline-adjusted ANCOVA models and focus group interviews. Registry-based recruitment identified 1378 potentially eligible individuals and 27 of 410 assessed (6.6%) enrolled, highlighting recruitment challenges. Retention was high (24/27; 88.9%). Adherence to RET and supplementation was strong (both > 85%) with no serious adverse events reported. Participants reported high acceptability for both in person and virtual components. No significant between group differences were observed for secondary outcomes; however, both groups demonstrated modest improvements in muscular strength and short physical performance battery (SPPB) scores. A hybrid RET program with CrM was feasible, acceptable and well tolerated in individuals with colorectal cancer who were previously treated with chemotherapy. Hybrid supervised RET is safe, acceptable, and associated with modest improvements in strength and physical function among individuals treated for colorectal cancer. While creatine supplementation did not demonstrate clear additive effects in this pilot trial, further adequately powered studies are warranted. Trial Registration: NCT06420726.
Clinical relevance
Is a 10-week hybrid (in-clinic and virtual) resistance exercise training (RET) program, with or without creatine monohydrate (CrM) supplementation, feasible, acceptable, and safe in individuals previously treated for colorectal cancer? __SNAPSHOT__ {"studyDesign":"Randomized controlled pilot/feasibility trial (parallel-group, placebo-controlled)","setting":"Not reported in abstract; hybrid in-clinic and virtual delivery model; registry-based recruitment","sampleSize":"n=27 (EXSUPP [RET + CrM]: n=13; EXPLA [RET + placebo]: n=14)","population":"Individuals previously treated for colorectal cancer (specifically identified as having received chemotherapy); recruited via registry from 1,378 potentially eligible individuals, with 410 assessed for eligibility","intervention":"Resistance exercise training (RET) 3 times per week for 10 weeks (hybrid in-clinic and virtual format) plus creatine monohydrate (CrM) 5 g/day","comparator":"RET 3 times per week for 10 weeks plus corn-starch maltodextrin placebo 5 g/day","primaryOutcome":"Feasibility: recruitment rate, retention, and fidelity (percentage of prescribed RET sessions and supplementation completed); acceptability via 5-point Likert scale; safety via adverse event reporting","followUp":"10 weeks (pre- and post-intervention assessment)","fundingSource":"Not reported"}
Key findings
Of 1,378 potentially eligible individuals identified via registry, 410 were assessed for eligibility and 27 enrolled, yielding an enrollment rate of 6.6% (27/410 assessed), highlighting a significant recruitment challenge. Retention was high at 88.9% (24/27). Adherence to both RET and supplementation exceeded 85% in both arms. No serious adverse events were reported. Participants reported high acceptability for both in-person and virtual components of the program. Regarding secondary outcomes (body composition, muscular strength, physical function), no statistically significant between-group differences were observed for either arm. However, both groups demonstrated modest within-group improvements in muscular strength and Short Physical Performance Battery (SPPB) scores. Specific effect sizes, confidence intervals, p-values, and absolute changes for secondary outcomes are not reported in the available abstract. NNT/NNH cannot be calculated from available data.
Practice implications
This pilot study established that a 10-week hybrid RET program, with or without CrM supplementation at 5 g/day, is feasible, acceptable, and safe in colorectal cancer survivors post-chemotherapy. The high retention (88.9%) and protocol adherence (>85% for both exercise and supplementation) are meaningful feasibility benchmarks for this population. However, the study was explicitly not powered to detect between-group differences in body composition, muscular strength, or physical function — these were secondary exploratory outcomes only, and the absence of significant between-group differences should not be interpreted as establishing equivalence. The 6.6% enrollment rate (27/410 assessed) underscores a critical barrier to scaling this intervention and raises concern about selection bias favoring highly motivated survivors in future trials. The modest within-group improvements in strength and SPPB scores are hypothesis-generating but cannot be attributed to either the exercise program or supplementation in isolation given the absence of a non-exercise control arm. Findings apply narrowly to colorectal cancer survivors treated with chemotherapy who are well enough to participate in supervised RET; patients with advanced disease, ongoing treatment, ostomy complications, or significant deconditioning were likely underrepresented. The study is drawn from an abstract only, which limits full appraisal of methods, randomization quality, blinding procedures, and complete secondary outcome data. __LIMITATIONS__ Very small sample size (n=27) with unequal group allocation; the trial was explicitly a feasibility study and not powered for efficacy conclusions.,Abstract-only availability precludes full assessment of randomization, allocation concealment, blinding integrity, and complete secondary outcome reporting.,Critically low enrollment rate (6.6%) from the assessed pool introduces selection bias; enrolled participants likely represent a highly motivated, functionally capable subset of colorectal cancer survivors.,No non-exercise control arm, precluding estimation of the independent effect of RET alone versus natural recovery or usual care.,Secondary outcomes (body composition, muscular strength, SPPB) were assessed using baseline-adjusted ANCOVA but specific effect sizes, confidence intervals, and p-values are not reported in the abstract.,Ten-week follow-up is short; durability of any musculoskeletal benefits and longer-term safety of CrM in this oncologic context are unknown.,Funding source not reported; potential conflicts of interest cannot be assessed.,Generalizability is limited to post-chemotherapy colorectal cancer survivors; patients with active treatment, metastatic disease, ostomy, or significant functional impairment are likely underrepresented.,Preclinical data raise unresolved biosafety concerns: creatine has been reported to promote colorectal and breast cancer metastasis in murine models, a signal that warrants consideration when extrapolating to clinical use. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ This pilot trial demonstrates that a 10-week hybrid resistance exercise training program, with or without 5 g/day creatine monohydrate, is feasible and well-tolerated in colorectal cancer survivors post-chemotherapy, with high retention and protocol adherence and no serious adverse events. No between-group differences in body composition, strength, or physical function were detected, though both groups showed modest within-group improvements in strength and SPPB scores. Confirmation in adequately powered RCTs is needed before CrM can be recommended as an adjunct to RET in this population, and the preclinical signal of creatine-promoted colorectal cancer metastasis warrants formal safety monitoring in any future definitive trial.