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NCT Number: NCT07838090

Resistance Training and Creatine Supplementation 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.

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Key information

Conditions

Head and Neck Cancer Behavior Cancer Survivorship Head and Neck Neoplasms Motor Activity Neoplasms Neoplasms by Site Physical Function Treatment-related Muscle Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

creatine supplementation

Dietary Supplement

Creatine monohydrate: 0.3g/kg x 7 days as loading dose followed by 0.1g/kg for the remainder of the study

Resistance training

Other

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)

Primary outcomes

  1. Recruitment rate

    Time frame: Up to 12 months

    Proportion of the target sample enrolled within the planned recruitment period.

  2. Participant Retention Rate

    Time frame: Through Week 18 (2-Month Follow-Up)

    Proportion of enrolled participants completing the Week 18 follow-up assessment.

  3. 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.

  4. 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.

Secondary outcomes

  1. 400-Meter Walk Test Completion Time

    Time frame: Baseline, Week 11 (Post-Intervention), and Week 18 (2-Month Follow-Up)

    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.

  2. 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)

    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.

  3. 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)

    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.

  4. Five Times Sit-to-Stand Test Completion Time

    Time frame: Baseline, 11 weeks (Post-Intervention), 18 weeks (2-month Follow-Up)

    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.

  5. Short Physical Performance Battery Summary Score

    Time frame: Baseline, 11 weeks (Post-Intervention), 18 weeks (2-month Follow-Up)

    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.

  6. 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)

    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.

  7. 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)

    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.

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Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • University of South Carolina

Registry information

Official study title

Pilot Randomized Trial Evaluating Resistance Exercise Training and Creatine Supplementation in Individuals Treated for Head and Neck Cancer

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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