Head and Neck CancerNCT07838090
Resistance Training and Creatine Supplementation for Head and Neck Cancer
A study testing Creatine Supplementation and Resistance Training in people with Head and Neck Cancer and Cancer Survivorship, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Cancer Survivorship, Treatment-related Muscle Loss
- What is being tested?
- Creatine Supplementation and Resistance Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 15 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Willingness and ability to participate in both in-person and/or virtual supervised exercise sessions.
- Willingness to adhere to the supplementation regimen throughout the study.
Show all 9Show fewer
- English-speaking and able to understand study instructions and complete questionnaires.
- Access to internet for remotely supervised exercise sessions.
- Availability for the full 10-week intervention and post-intervention assessments.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
Brian Cence, 843-792-2668, cence@musc.edu
About this study
Official title: Pilot Randomized Trial Evaluating Resistance Exercise Training and Creatine Supplementation in Individuals Treated for Head and Neck Cancer
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.
Read the detailed description
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.
- Conditions
- Head and Neck Cancer, Cancer Survivorship, Treatment-related Muscle Loss, Physical Function
- Being tested
- Creatine Supplementation, Resistance Training
- Keywords
- Cancer, Exercise, Rehabilitation Studies, Head and Neck Cancer, Resistance Training, Creatine Monohydrate, Cancer Survivorship
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine SupplementationDietary supplement
Creatine monohydrate: 0.3g/kg x 7 days as loading dose followed by 0.1g/kg for the remainder of the study
Resistance TrainingOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training and Creatine | Experimental | Resistance training plus creatine monohydrate (load 0.3g/kg x 7 days, then 0.1g/kg/day) Receives: Dietary Supplement: Creatine Supplementation; Other: Resistance Training |
| Resistance Training and Placebo | Placebo comparator | resistance training plus matched placebo Receives: Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of the target sample enrolled within the planned recruitment period.
Measured: Up to 12 months
Participant Retention Rate
Proportion of enrolled participants completing the Week 18 follow-up assessment.
Measured: 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.
Measured: 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.
Measured: Baseline through Week 18 (2-Month Follow-Up)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 11 weeks (Post-Intervention), 18 weeks (2-Month Follow-Up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized controlled trial evaluating a 10-week hybrid resistance training and supplementation program in adult survivors of head and neck cancer. Study team to complete final arm/intervention structure in PRS.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Chris Gregory, PhD, PT, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838090
- Sponsor's protocol ID
- Pro00148118
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial Evaluating Resistance Exercise Training and Creatine Supplementation in Individuals Treated for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT07838090
- Acronym / sponsor ID
- Pro00148118
- Conditions
- Head and Neck Cancer, Cancer Survivorship, Treatment-related Muscle Loss, Physical Function
- Keywords
- Cancer, Exercise, Rehabilitation Studies, Head and Neck Cancer, Resistance Training, Creatine Monohydrate, Cancer Survivorship
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- University of South Carolina
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized controlled trial evaluating a 10-week hybrid resistance training and supplementation program in adult survivors of head and neck cancer. Study team to complete final arm/intervention structure in PRS.
| Arm | Type | Receives |
|---|---|---|
| Resistance Training and Creatine | Experimental | Dietary Supplement: Creatine Supplementation, Other: Resistance TrainingResistance training plus creatine monohydrate (load 0.3g/kg x 7 days, then 0.1g/kg/day) |
| Resistance Training and Placebo | Placebo comparator | Other: Resistance Trainingresistance training plus matched placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Willingness and ability to participate in both in-person and/or virtual supervised exercise sessions.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine SupplementationCreatine monohydrate: 0.3g/kg x 7 days as loading dose followed by 0.1g/kg for the remainder of the study | Dietary supplement | Resistance Training and Creatine |
| Resistance TrainingResistance 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) | Other | Resistance Training and Creatine, Resistance Training and Placebo |
Primary outcome
Recruitment rate
Time frame: Up to 12 months
Proportion of the target sample enrolled within the planned recruitment period.
Participant Retention Rate
Time frame: Through Week 18 (2-Month Follow-Up)
Proportion of enrolled participants completing the Week 18 follow-up assessment.
Intervention Adherence Rate
Time frame: Through Week 10 Intervention Period
Proportion of participants completing at least 75% of prescribed resistance training sessions and at least 75% of prescribed creatine supplementation doses.
Outcome Assessment Completion Rate
Time frame: Baseline through Week 18 (2-Month Follow-Up)
Proportion of participants with evaluable physical function, body composition, and patient-reported outcome data at all scheduled assessment time points.
7 secondary outcomes
400-Meter Walk Test Completion Time
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)
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
Time frame: Baseline, Week 11 (Post-Intervention), and Week 18 (2-Month Follow-Up)
Five Times Sit-to-Stand Test Completion Time
Time frame: Baseline, 11 weeks (Post-Intervention), 18 weeks (2-month Follow-Up)
Short Physical Performance Battery Summary Score
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
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)
Time frame: Baseline, 11 weeks (Post-Intervention), 18 weeks (2-Month Follow-Up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Gregory, PhD, PT principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Supplementation and Resistance Training in people with Head and Neck Cancer and Cancer Survivorship, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Cence (8437922668, cence@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.