Clinical trial · Interventional
A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery
A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery: A Randomized Trial
NCT03115398CI-TRIAL-00108062completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
By utilizing fitness trackers, this study aims to demonstrate that a simple walking program improves patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pedometer-based Walking Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Activity Monitoring with Routine Care
- description
- Subjects randomized to the control arm will wear activity trackers but will have no specific instructions to increase their activity levels.
- type
- EXPERIMENTAL
- label
- Pedometer-based Walking Program
- description
- Subjects randomized to the experimental arm will be instructed to meet the customized daily step count goals that are displayed on their fitness trackers. Patients who fail to meet their step count goal for three consecutive days will be contacted by a study coordinator and reminded to try to meet the activity goals. If the patient reports that his or her activity is limited by treatment-related toxicities, the patient's treating physicians will be notified to ensure that supportive care needs are being met.
- interventionNames
- Behavioral: Pedometer-based Walking Program
Primary outcomes (1)
- measure
- Number of Missed Scheduled Radiotherapy Treatments
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 * ECOG performance status 0-2 * Able to ambulate independently (without the assistance of a cane or walker) * Diagnosis of invasive malignancy of the brain, head and neck region, lung, gastrointestinal tract, or uterine cervix * Planned treatment with fractionated (≥15 treatments) external beam radiotherapy with concurrent chemotherapy (or cetuximab) with curative intent (including preoperative or postoperative treatment) * Women of childbearing potential must: * Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy * Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed * Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy. * All patients must sign study specific informed consent prior to study entry.
References
Publications (0)
Data not yet available
No reference posted for this study.