Pilot Randomized Trial Evaluating Resistance Exercise Training and Creatine Supplementation in Individuals Treated for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Resistance Training and Creatine
Resistance training plus creatine monohydrate (load 0.3g/kg x 7 days, then 0.1g/kg/day)
干预措施: Resistance Training (Other)
Resistance Training and Placebo
resistance training plus matched placebo
干预措施: Resistance Training (Other)
Resistance Training and Creatine
Resistance training plus creatine monohydrate (load 0.3g/kg x 7 days, then 0.1g/kg/day)
干预措施: Creatine Supplementation (Dietary Supplement)
结局指标
主要结局
Recruitment rate
时间窗: Up to 12 months
Proportion of the target sample enrolled within the planned recruitment period.
Participant Retention Rate
时间窗: Through Week 18 (2-Month Follow-Up)
Proportion of enrolled participants completing the Week 18 follow-up assessment.
Intervention Adherence Rate
时间窗: 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
时间窗: 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.
次要结局
- 400-Meter Walk Test Completion Time(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)(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(Baseline, Week 11 (Post-Intervention), and Week 18 (2-Month Follow-Up))
- Five Times Sit-to-Stand Test Completion Time(Baseline, 11 weeks (Post-Intervention), 18 weeks (2-month Follow-Up))
- Short Physical Performance Battery Summary Score(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(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)(Baseline, 11 weeks (Post-Intervention), 18 weeks (2-Month Follow-Up))