- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07523919
Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes
The Impact of Functional Status and Respiratory Parameters on Long-Term Outcomes in Colorectal Cancer
Colorectal cancer is one of the most commonly diagnosed malignancies worldwide and a leading cause of cancer-related morbidity and mortality. Its global incidence continues to increase, with a substantial proportion of cases diagnosed at advanced stages, which adversely affects prognosis. Patients diagnosed at an early stage and treated with surgery have significantly better long-term survival outcomes. Five-year survival rates are approximately 90% for stage I disease, decreasing to around 70% in stage II and 60% in stage III, and dropping to as low as 8% in stage IV disease.
Advanced age, family history, and environmental exposures are well-established risk factors for colorectal cancer. In addition, modifiable lifestyle factors-including smoking, physical inactivity, unhealthy dietary patterns, and obesity-have been shown to significantly increase the risk of disease.
Although surgical resection remains the cornerstone of curative treatment in colorectal cancer, long-term outcomes are influenced not only by tumor stage but also by various patient-related factors, including comorbidities, functional capacity, and respiratory reserve. Functional status, which reflects a patient's ability to perform activities of daily living, is a key determinant of postoperative recovery and long-term outcomes. Reduced functional capacity has been associated with poorer long-term survival, diminished quality of life, and increased late morbidity. Therefore, objective preoperative assessment of functional status is considered essential for predicting long-term prognosis.
Respiratory function also plays a critical role, particularly in patients undergoing abdominal surgery. Impaired pulmonary capacity increases the risk of postoperative pulmonary complications, prolongs hospital stay, and may indirectly affect long-term survival. However, studies evaluating the impact of preoperative respiratory parameters on long-term outcomes in patients with colorectal cancer remain limited. Furthermore, comprehensive analyses integrating both functional capacity and respiratory function are scarce in the current literature. Therefore, further investigation in this area is warranted.
The aim of this study is to evaluate the impact of functional status and respiratory parameters on long-term clinical outcomes in patients with colorectal cancer.
H0: There is no statistically significant association between functional status, respiratory parameters, and long-term clinical outcomes in patients with colorectal cancer.
H1: There is a statistically significant association between functional status, respiratory parameters, and long-term clinical outcomes in patients with colorectal cancer.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Müşerref Ebru YALÇIN, PhD
- Phone Number: +905557136666
- Email: M.ebrusen@gmail.com
Study Locations
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Gümüşhane Province
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Merkez, Gümüşhane Province, Turkey (Türkiye), 29000
- Recruiting
- İnönü University Turgut Özal Medical Center General Surgery Polyclinic
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Contact:
- MÜŞERREF EBRU YALÇIN
- Phone Number: +905557136666
- Email: M.ebrusen@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 and 80 years
- Voluntary participation in the study
Exclusion Criteria:
- Presence of musculoskeletal disorders that may prevent completion of the required tests
- Presence of cognitive impairment
- History of psychiatric disease
- History of major surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Colorectal Cancer Patients
This cohort consists of patients with colorectal cancer undergoing surgical treatment.
Functional status and respiratory parameters are assessed preoperatively, and patients are followed to evaluate long-term clinical outcomes.
No additional intervention beyond standard care is performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Six-Minute Walk Test (6MWT)
Time Frame: 2 years
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2 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 9. Mima, K., Kosumi, K., Miyanari, N., Tajiri, T., Kanemitsu, K., Takematsu, T., … Baba, H. (2021). Impairment of activities of daily living is an independent risk factor for recurrence and mortality following curative resection of stage I-III colorectal cancer. Journal of Gastrointestinal Surgery, 25(10), 2628-2636. 10. Overcash, J. (2015). Assessing the functional status of older cancer patients in an ambulatory care visit. Healthcare, 3(3), 846-859. 11. Takahashi, K., Chiba, K., Honda, A., Iizuka, Y., Yoshinaga, K., Deo, A. S., & Uchida, T. (2025). Pre-operative subjective functional capacity and postoperative outcomes in adult non-cardiac surgery: A systematic review and meta-analysis. Anaesthesia, 80(5), 561-571. 12. Wilson, I. B., & Cleary, P. D. (1995). Linking clinical variables with health-related quality of life: A conceptual model of patient outcomes. JAMA, 273(1), 59-65. 13. Minnella, E. M., Liberman, A. S., Charlebois, P., Stein, B., Scheede-Bergdahl, C., Awasthi, R., … Carli, F. (2019). The impact of improved functional capacity before surgery on postoperative complications: A study in colorectal cancer. Acta Oncologica, 58(5), 573-578. 14. Sánchez-Torralvo, F. J., González-Poveda, I., García-Olivares, M., Porras, N., Gonzalo-Marín, M., Tapia, M. J., … Olveira, G. (2022). Poor physical performance is associated with postoperative complications and mortality in preoperative patients with colorectal cancer. Nutrients, 14(7), 1484.
- 1. Mao, J. X., Gao, R., Wang, Y., Yan, X. B., & Wang, H. H. (2025). Surgical treatment of colorectal cancer: A multidimensional review. World Journal of Gastrointestinal Surgery, 17(8), 107785. 2. Pickhardt, P. J., Kim, D. H., Pooler, B. D., Hinshaw, J. L., Barlow, D., & Mccoy, A. (2011). Colorectal cancer: CT colonography and colonoscopy for detection-Systematic review and meta-analysis. Radiology, 259(2), 393-405. 3. Toma, M., Beluşică, L., Stavarachi, M., Apostol, P., Spandole, S., Radu, I., & Cimponeriu, D. (2012). Rating the environmental and genetic risk factors for colorectal cancer. Journal of Medicine and Life, 5(Special Issue), 152-159. 4. Carr, P. R., Weigl, K., Jansen, L., Walter, V., Erben, V., Chang-Claude, J., Brenner, H., & Hoffmeister, M. (2018). Healthy lifestyle factors associated with lower risk of colorectal cancer irrespective of genetic risk. Gastroenterology, 155(6), 1805-1815.e5. 5. de Nes, L. C. F. (2025). Assessment and improvement of quality of care in colorectal cancer surgery (Doctoral dissertation). 6. Tomruk, M., Karadibak, D., Yavuzşen, T., & Akman, T. (2015). Predictors of functional capacity in colorectal cancer patients. Supportive Care in Cancer, 23(9), 2747-2754. 7. van Rooijen, S., Carli, F., Dalton, S., Thomas, G., Bojesen, R., Le Guen, M., … Slooter, G. (2019). Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: The first international randomized controlled trial for multimodal prehabilitation. BMC Cancer, 19(1), 98. 8. Whelan, M., van Aswegen, H., Roos, R., Fabian, J., & Bebington, B. (2021). Preoperative physical activity and functional performance levels are predictors of acute postoperative outcomes in a private South African colorectal cancer cohort. South African Journal of Physiotherapy, 77(1), 1526.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Respiratory Tract Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Respiration Disorders
- Colonic Diseases
- Pathological Conditions, Signs and Symptoms
- Colorectal Neoplasms
- Respiratory Aspiration
Other Study ID Numbers
- 2026/9561
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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