Clinical trial · Interventional
Prehabilitation Protocol for Head and Neck Cancer Patients
Optimizing Cancer Support Services Usage in Patients With Head and Neck Cancer During the Prehabilitation Period
NCT07318220CI-TRIAL-00125148recruitingN/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)
The purpose of this research is to help researchers understand the barriers, supports, and preferences for prehabilitation. Prehabilitation in this study means head and neck cancer patients will receive nutritional counseling sessions and attend exercise programs before and during radiotherapy/chemoradiotherapy treatment.
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 |
|---|---|---|---|
| Referral to Oncology Nutritional Counseling and Exercise Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aim 2: Prehabilitation Prescription Protocol Group
- description
- Participants in this group will be referred to a prehabilitation prescription protocol of nutritional counseling and exercise for HNC patients. Participants will attend for nutritional counseling and exercise sessions for the duration of their radiation therapy (RT) or chemoradiation therapy (CRT) for HNC. The duration of these sessions depends on the participant's treatment plan and the timing of enrollment. Participants will also have three in-person assessments during the study period during the following timepoints (T), to assess feasibility and acceptability of the prehabilitation prescription protocol: Baseline (T1), at the completion of RT/CRT (T2), and 8 weeks after the completion of RT/CRT and the exit survey (T3). Total participation duration is up to 18 weeks.
- interventionNames
- Behavioral: Referral to Oncology Nutritional Counseling and Exercise Program
Primary outcomes (3)
- measure
- Aim 2: Feasibility of Participant Engagement in Prehabilitation Prescription Program
- timeFrame
- Up to 18 Weeks
- description
- Feasibility will be measured as the percentage of participants that agree to participate in the prehabilitation prescription protocol. Criterion for success: At least (≥) 50% of all eligible participants agree to participate in the prehabilitation prescription protocol.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Aim 2 Inclusion Criteria: Implement prehabilitation prescription protocol and evaluate the feasibility and acceptability of the prehabilitation prescription protocol in a sample of HNC patients. 1. Age 18 to 80 years old 2. Patients with a diagnosis of squamous cell carcinoma originating in the head and neck (oral cavity, oropharynx, hypopharynx, larynx, and nasopharynx). 3. Stage I-III or de novo Stage IV 4. Patients with a plan for radiation therapy (RT) / chemoradiation therapy (CRT) at SCCC\* - \*Patients who underwent surgery for the HNC are still eligible. 5. If this is a second primary squamous cell carcinoma originating in the head and neck, a patient is eligible if the last RT or CRT was completed more than 6 months ago. 6. Clearance for exercise by the medical team. 7. Patients who do not have their first treatment scheduled within 7 days at the time of recruitment. 8. An English or Spanish speaker. Aim 2 Exclusion Criteria: 1. A patient who cannot complete the baseline assessment and/or start prehabilitation by the initiation of RT/CRT. 2. Any contraindication for diet change or exercising as determined by a physician. 3. A patient who is not an English or Spanish speaker. 4. History of dementia or major psychiatric disease which would interfere with study. 5. History of recent (≤1 yr) stroke, myocardial infarction, or congestive heart failure 6. Eastern Cooperative Oncology Group (ECOG) equal to or higher than 2.
References
Publications (0)
Data not yet available
No reference posted for this study.