Impact of daily step count on treatment response in rectal cancer
Prospective Observational Study of the Association Between Daily Step Count and Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Total Neoadjuvant Therapy: STEP-R Trial
This study is testing if walking more each day can help people with locally advanced rectal cancer have better treatment results and fewer side effects during their therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Gazi University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Ankara, Yenimahalle and 1 other locations) |
| Trial ID | NCT06668402 on ClinicalTrials.gov |
What this trial studies
This study examines how daily physical activity, specifically step count, affects treatment outcomes and side effects in patients with locally advanced rectal cancer undergoing total neoadjuvant therapy. Participants will wear Huawei Watch Fit 2 smartwatches to track their daily step counts, heart rate, and sleep quality throughout their treatment. The study aims to determine if higher physical activity levels correlate with better pathological response rates at surgery and fewer treatment-related side effects. Participants will also complete quality of life and sleep quality questionnaires at the beginning and end of treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with locally advanced rectal cancer who are eligible for total neoadjuvant therapy.
Not a fit: Patients with stage I or metastatic rectal cancer, or those with severe health conditions that limit mobility, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how increasing physical activity may improve treatment outcomes and quality of life for rectal cancer patients.
How similar studies have performed: While studies have shown general health benefits of physical activity in cancer patients, this specific approach using wearable technology for real-time data collection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years and older. * Diagnosed with locally advanced rectal cancer (stage II or III) and eligible for total neoadjuvant therapy (TNT). * Planned to undergo chemotherapy and radiotherapy as part of neoadjuvant treatment before surgery. * Capable of providing informed consent. * Able to wear and operate the Huawei Watch Fit 2 smartwatch throughout the treatment period. * Sufficient mobility to engage in physical activity, including walking, as per study requirements. * Willing to complete weekly monitoring visits and complete the EORTC QLQ-C30 and Pittsburgh Sleep Quality Index questionnaires at baseline and study end Exclusion Criteria: * Stage I or metastatic (stage IV) rectal cancer. * Contraindications to physical activity, including but not limited to severe cardiovascular or respiratory conditions that limit mobility. * Prior treatment for rectal cancer with chemotherapy or radiotherapy. * Use of a pacemaker or other implanted medical devices that might interfere with smartwatch functionality. * Known allergic reaction to materials in the Huawei Watch Fit 2 smartwatch. * Severe cognitive or psychological disorders that would hinder participation in the study or completion of questionnaires. * Any medical or psychiatric condition that, in the opinion of the investigator, may compromise patient safety or interfere with study adherence.
Where this trial is running
Ankara, Yenimahalle and 1 other locations
- Etlik City Hospital — Ankara, Yenimahalle, Turkey (Recruiting)
- Gazi University — Ankara, Yenimahalle, Turkey (Recruiting)
Study contacts
- Principal investigator: Orhun Akdogan, MD — Gazi University
- Study coordinator: Ozan Yazici, Prof. Dr.
- Email: drozanyazici@gmail.com
- Phone: +905055873568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.