Clinical trial · Interventional
Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment
A Pilot Study to Assess Feasibility of a Clinically Significant Increase in Physical Activity in Patients With Head and Neck Cancer Undergoing Active Treatment
NCT04788264CI-TRIAL-00090043completedN/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)
This clinical trial evaluates the tolerability of a physical activity program in head and neck cancer patients who are undergoing cancer treatment. The goal of this trial is to give patients exercises prescribed by a physical therapist that they are able to complete regularly at home. Increasing physical activity may help patients reduce fatigue, improve mood, increase physical performance, and decrease joint pain.
Conditions
Conditions (16)
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 Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hypopharyngeal Carcinoma | Hypopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Laryngeal Carcinoma | Laryngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Maxillary Sinus Carcinoma | Maxillary Sinus Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oral Cavity Carcinoma | Oral Cavity Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oropharyngeal Carcinoma | Oropharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Paranasal Sinus Carcinoma | Paranasal Sinus Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Sinonasal Carcinoma | Sinonasal Carcinoma |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Intervention | Behavioral | — | UNRESOLVED |
| Consultation | Other | — | UNRESOLVED |
| Exercise Intervention | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Other | — | UNRESOLVED |
| Quality of Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (exercise training, behavior modification)
- description
- Beginning 1 week prior to start of intervention, patients receive a Fitbit to monitor physical activity for 13 weeks. Patients receive consultation and personalized exercise prescription from a physical therapist at baseline, and attend exercise training sessions with a physical therapist during weeks 1, 3, 6, 9, and 12. Patients also attend behavior modification sessions with a behavioral therapist that focus on goal setting and healthy behavior changes during weeks 2, 4, 5, 7, 8, 10, and 11.
- interventionNames
- Other: Medical Device Usage and Evaluation
- Other: Consultation
- Other: Exercise Intervention
- Behavioral: Behavioral Intervention
- Other: Questionnaire Administration
- Other: Quality of Life Assessment
- type
- ACTIVE_COMPARATOR
- label
- Arm II (Fitbit, consultation)
- description
- Patients receive a Fitbit to monitor physical activity for 12 weeks. Patients also receive consultation from a physical therapist to assess physical performance at weeks 1, 6, and 12.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with head and neck cancer including cancers of the sinuses, oral cavity, oropharynx, hypopharynx, or larynx (all stages); therapeutically eligible to receive at least three months of immunotherapy * Medically cleared by oncologist to engage in aerobic and resistance exercise intervention * 18 years of age or older * Access to a smartphone and have an active wi-fi connection at home * Able to read and/or to speak English * Able to comprehend and sign a written informed consent (no cognitive decline) * Women of reproductive potential must have a negative serum or urine pregnancy test within the week prior to starting therapy Exclusion Criteria: * Severe or unstable cardiopulmonary, metabolic, or renal disease as determined by the referring oncologist * Unable to walk safely without physical assistance of another person * Any condition that may limit the ability to comply with behavioral recommendations of the program * Pregnant or planning a pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.