Clinical trial · Interventional
Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI chose not to continue with this unfunded study
Summary
Brief summary (as posted)
Generally, patients who have undergone treatments for Head Neck Cancer have a decreased quality of life and experience depression and fatigue. Regular physical activity improves emotional well-being, increases immunological response, improves wound healing, lessens fatigue and improves general functionality and quality of life. This study will determine effectiveness of the 12-week exercise intervention program, determine if physically active patients differ in quality of life, depression and fatigue during the course of the study, and determine if the change in physical activity levels is related to changes in immune responses.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Attention Control
- description
- 5ml of blood will be collected from each blood draw at baseline and post-intervention to assay for Interleukin-6 level. Patient will be taught how to keep the Activity diary to record walking and physical activities. Structured Interview will be conducted at baseline and post-intervention. All patients will receive 3 reminder phone calls during the first week of study and 10 minutes social visits in the following weeks by study coordinator on a weekly basis
- interventionNames
- Behavioral: Intervention group
Primary outcomes (1)
- measure
- Self-report of physical activity behavior (duration, intensity and frequency)
- timeFrame
- Baseline and Post Intervention
- description
- Participants will be taught how to keep the Activity diary to record walking and physical activities.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients 19 years of age or above (Nebraska legal age). 2. Patients diagnosed with HNC who are seen at the University of Nebraska Medical Center. 3. Patients who have undergone chemotherapy, radiation and/or surgery for their cancer. 4. Patients who have completed their cancer treatment at least 3 months prior. 5. Patients who have consented to participate in this study with approval by their physicians. 6. Patients who have no significant mental impairment. Exclusion Criteria: 1. Patients who are on enteral feeding. 2. Patients who are not able to walk or whose surgeons report that walking is not advisable. 3. Patients diagnosed with Lymphoma, Thyroid cancer or Melanoma. 4. Patients who are on antidepressant medications. 5. Patients who are unwilling to return to the clinic at the end of the study - after 12 weeks of intervention. 6. Patients participating in another research study involving a therapeutic intervention. 7. Patients with chronic medical and orthopedic conditions that would preclude physical activity (e.g., congestive heart failure, recent knee or hip replacements). 8. Patients who are at 18 months or more after the start of cancer treatment.
References
Publications (0)
Data not yet available