An interventional study of Creatine Supplementation and Resistance Training in Head and Neck Cancer, Cancer Survivorship and Treatment-related Muscle Loss, sponsored by Medical University of South Carolina. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
Among 17 studies in Head and Neck Neoplasms by Medical University of South Carolina — 5 open to participants now, 5 under way, none of them phase 3. Head and Neck Neoplasms · Medical University of South Carolina.
Among the 17 studies in Head and Neck Neoplasms by Medical University of South Carolina, this one is the 7th largest by planned enrollment of the 15 interventional ones, is one of 3 that started in 2026, is one of 12 with no phase, and was the 17th registered.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 30 is below the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →5 of the 17 studies in Head and Neck Neoplasms by Medical University of South Carolina are open now, in 1 country. Each count lists the studies.
Of the 453 Head and Neck Neoplasms studies recruiting now, 345 (76%) set no upper age limit and 51 (11%) stop at 75 or younger; 21 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2026.
Median enrollment 30 across the 15 interventional studies, 65 across the 2 observational. Of the 11 that completed or were terminated, 6 (55%) have results posted.
Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
1 of the studies in Head and Neck Neoplasms by Medical University of South Carolina that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05442957Medical University of South CarolinaBuilding a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT | 2027-01-30 |
Among the 17 studies in Head and Neck Neoplasms by Medical University of South Carolina, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
This pilot randomized controlled trial is designed to evaluate the feasibility, acceptability, and safety of a 10-week hybrid resistance training program combined with daily creatine monohydrate supplementation in adult survivors of head and neck cancer. The study population includes individuals with AJCC stage I-IV head and neck cancer who have completed curative-intent primary treatment within the past 1 to 3 months.
Participants will be recruited from MUSC and the greater Charleston area. Study procedures include screening, informed consent, baseline assessments, randomization, completion of a 10-week resistance training program delivered using an in-person and telehealth hybrid model, daily study supplementation as assigned by the study team, post-intervention assessment, and follow-up assessment. The intervention includes supervised resistance training sessions targeting major muscle groups, with initial in-person instruction and subsequent remotely supervised sessions supported by study staff. Study activities will be conducted at the Medical University of South Carolina College of Health Professions Research Building and/or the Neurological Exercise \& Training (NExT) Wellness Center, with virtual delivery support from the University of South Carolina Exercise Oncology Lab.
The purpose of this pilot study is to determine whether the study procedures and intervention components are feasible and acceptable for a future larger trial and to collect preliminary data related to physical recovery and survivorship outcomes after head and neck cancer treatment. Arms, interventions, and outcome measure records are intentionally left blank in this XML skeleton for study-team completion in PRS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Resistance training plus creatine monohydrate (load 0.3g/kg x 7 days, then 0.1g/kg/day)
Dietary Supplement: Creatine Supplementation · Other: Resistance Training
resistance training plus matched placebo
Other: Resistance Training
Creatine monohydrate: 0.3g/kg x 7 days as loading dose followed by 0.1g/kg for the remainder of the study
Resistance 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)
Recruitment rate
Proportion of the target sample enrolled within the planned recruitment period.
Time frame: Up to 12 months
Participant Retention Rate
Proportion of enrolled participants completing the Week 18 follow-up assessment.
Time frame: Through Week 18 (2-Month Follow-Up)
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 Period
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)
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)
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)
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)
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)
Short Physical Performance Battery Summary Score
Tool used to evaluate lower-extremity physical function, mobility, and balance. It includes balance tests, gait speed test, and chair stand test, each scored 0 to 4. The subtest scores are summed to calculate a total categorical summary score ranging from 0 to 12. higher scores indicate better physical function than lower scores.
Time frame: Baseline, 11 weeks (Post-Intervention), 18 weeks (2-month Follow-Up)
Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) Questionnaire
The FACT-H\&N is a 39-item instrument to evaluate health-related quality of life over the past 7 days specifically in patients with head and neck cancer. Each item is scores on a 5-point Likert scale from 0 (not at all) to 4 (very much). Total scores range from 0 to 156. Higher scores indicate better quality of life.
Time frame: Baseline, 11 weeks (Post-Intervention), 18 weeks (2-Month Follow-Up)
Symptom burden as assessed by the MD Anderson Symptom Inventory- Head and Neck Module (MDASI-HN)
The MDASI-HN is a 18-item questionnaire to assess the severity of multiple symptoms and their impact on daily functioning in patients treated for head and neck cancer. It consists of 3 subscales: 13 core cancer symptoms, 9 head and neck cancer-specific symptoms, and 6 interference items evaluating how much symptoms affect daily activities over a 24-hour recall period. Each item is scores on an 11-point numerical scale ranging from 0 (not present/did not interfere) to 10 (as bad as you can imagine/interfered completely). Scores can be evaluated as individual subscale means or as an overall total score ranging from 0 to 280. Higher scores indicate greater symptom severity and worse functional interference.
Time frame: Baseline, 11 weeks (Post-Intervention), 18 weeks (2-Month Follow-Up)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Sep 2028, 22 months later.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 22 months is below that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Oct 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina →