Resistance Training and Creatine Supplementation for Head and Neck Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
The study will examine a 10-week resistance training program, with or without creatine monohydrate supplementation, in adult survivors of head and neck cancer. Participants will undergo screening and complete study assessments before and after the training period and at a follow-up evaluation. The study will evaluate feasibility, safety, body composition, physical function, cancer-related fatigue, quality of life, and symptom burden in this population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Diagnosis of head and neck cancer (AJCC stages I-IV).
Completed curative-intent primary treatment, including surgery, radiation, chemotherapy, or combination treatment, within the past 1 to 3 months.
Clearance to engage in moderate-intensity exercise based on the American College of Sports Medicine (ACSM) Preparticipation Screening Guidelines.
Disqualifiers
Current participation in structured resistance training 2 or more days per week within the past 6 months.
Cognitive, psychiatric, or neurologic conditions that would impair ability to consent or adhere to study procedures.
Pre-existing renal impairment.
Current use of creatine supplements, defined as consistently taking creatine more than 2 days per week for the past 6 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Creatine Supplementation
Dietary supplementCreatine monohydrate: 0.3g/kg x 7 days as loading dose followed by 0.1g/kg for the remainder of the study
Resistance Training
Other interventionResistance training: 3 sessions per week (30 sessions total), hybrid format (in-person and telehealth), 45-60 minutes, followed progressive resistance training protocol, 1:1, supervised. Each session has three components (warm up, primary workout, cool-down phase)
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Resistance Training and CreatineExperimental treatment 2 interventions
Group B: Resistance Training and PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Proportion of the target sample enrolled within the planned recruitment period.
Time frame
Up to 12 months2
Participant Retention Rate
Proportion of enrolled participants completing the Week 18 follow-up assessment.
Time frame
Through Week 18 (2-Month Follow-Up)3
Intervention Adherence Rate
Proportion of participants completing at least 75% of prescribed resistance training sessions and at least 75% of prescribed creatine supplementation doses.
Time frame
Through Week 10 Intervention Period4
Outcome Assessment Completion Rate
Proportion of participants with evaluable physical function, body composition, and patient-reported outcome data at all scheduled assessment time points.
Time frame
Baseline through Week 18 (2-Month Follow-Up)Secondary outcomes
1
400-Meter Walk Test Completion Time
The 400-Meter Walk Test evaluated physical function, mobility, and walking endurance. It measures the time it takes a participant to walk the 400-meter distance. The total time is recorded in seconds using a stopwatch.
Time frame
Baseline, Week 11 (Post-Intervention), and Week 18 (2-Month Follow-Up)2
Body Composition Assessed by Bioelectrical Impedance Analysis (Percent Body Fat and Total Lean Mass)
Body composition will be assessed using bioelectrical impedance analysis (BIA), including percent body fat and total lean mass. The protocol identifies these as the body composition outcomes of interest.
Time frame
Baseline, Week 11 (Post-Intervention), and Week 18 (2-Month Follow-Up)3
Fatigue as assessed by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
The FACIT-Fatigue is a 13-item self-report questionnaire that assesses the severity and impact of fatigue on daily activities over the past 7 days. Each item is scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total scores range from 0 to 52. Higher scores indicate less fatigue, while lower scores indicate more severe fatigue.
Time frame
Baseline, Week 11 (Post-Intervention), and Week 18 (2-Month Follow-Up)4
Five Times Sit-to-Stand Test Completion Time
This test evaluated functional lower-body muscle strength, balance, and transitional mobility. The total time to complete 5 full repetitions of sitting and standing with a standard, armless chair placed against a wall, is recorded in seconds.
Time frame
Baseline, 11 weeks (Post-Intervention), 18 weeks (2-month Follow-Up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
University of South Carolina
Collaborator
Source ClinicalTrials.gov
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