Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy - The DAHANCA 31 Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in LBM (lean body mass)
研究概览
简要总结
72 patients with head and neck cancer, undergoing primary treatment with radiation therapy and concomitant weekly cisplatin, will be recruited to this multicentre trial.
Randomized 1:1 to either 12-week progressive resistance training (PRT) program or control arm, starting together with concomitant chemoradiotherapy (CCRT) Stratified by centre, gender, p16-status and body mass index (BMI) below or above 30.
Primary endpoint is difference in change in lean body mass (LBM) between the groups and the endpoint is reduction of LBM loss in intervention arm by 25% compared to control.
Secondary endpoints include side-effects to treatment, change in body composition, physical function and strength, and compliance to PRT. Questionnaires on QoL, diet, voluntary exercise and work affiliation will also be registered.
Blood samples for explorative analyses will be drawn and optional muscle biopsies drawn for proteomics analyses and histological analyses.
详细描述
The PRT program will start about the onset of radiotherapy. The program consists of 7 exercises in training machines and involves the major muscle groups of the body.
The program has previously been found to successfully restore the loss of lean body mass (LBM) in head and neck cancer patients post-treatment. A group based approach will be used to facilitate a social and motivating training environment for the patients. A pilot study (NCT02068950) showed feasibility of PRT during CCRT.
In addition to baseline data (height, tumor stage, performance status, etc), the following parameters will be registered: Weight, patient reported side effects, as well as a questionnaire on amount of physical activity and food intake.
Physical function and strength will be tested at baseline, after the course of chemoradiotherapy and at the end of the 12-week PRT programme, and at 6 and 12 months follow-up. DXA scans for body composition will be performed using a Lunar iDXA (GE Healthcare).
Blood samples will be drawn at regular intervals during the 12 weeks and at follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 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
- •Patients with biopsy verified head and neck squamous cell carcinoma referred for primary curatively intended treatment.
- •Candidates for concomitant chemoradiotherapy (2Gyx33-34; 6F/W; weekly cisplatin 40mg/m2, max. 70 mg/weekly) according to Danish Head and Neck Cancer Group (DAHANCA) guidelines (T1-4, N1-3, M0)
- •Performance status 0-1
- •At least 18 years of age.
排除标准
- •BMI below 20.5
- •corticosteroid treatment for other diseases
- •Tonsillectomy within the last week before inclusion.
- •hemoglobin below 6 mmol/l
- •leucocytes below 2.5 x 10^9 /l
- •thrombocytes below 50 x 10^9 /l
- •comorbidities, social, familial or geographical conditions, that could compromise attendance or results
结局指标
主要结局
Change in LBM (lean body mass)
时间窗: at 12-weeks post PRT
change in kilograms
次要结局
- Fat mass(at 6 and 12 weeks, and 6 and 12 months post RT)
- Change in LBM (lean body mass)(at 6 weeks, and 6 and 12 months post RT)
- Weight loss(at 6 and 12 weeks, and 6 and 12 months post RT)
- Patient reported pain(at 6 and 12 weeks, and 6 and 12 months post RT)
- Patient reported Quality of Life(at 6 and 12 weeks, and 6 and 12 months post RT)
- Muscle strength(at 6 and 12 weeks, and 6 and 12 months post RT)
- Chair rise(at 6 and 12 weeks, and 6 and 12 months post RT)
- arm curls(at 6 and 12 weeks, and 6 and 12 months post RT)
- Stair climb(at 6 and 12 weeks, 6 and 12 months)
- Compliance to PRT program(at 12 weeks post PRT)
- Physical activity(at 6 and 12 weeks, and 6 and 12 months post RT)
- Percent of patients with feeding tubes(at 6 and 12 weeks, and 6 and 12 months post RT)
- Resumption of work(At 12 months follow-up)
- Percent relapses(at 12 months follow-up)
- Cytokines(at 3, 6, 8, 10, and 12 weeks)
- Muscle biopsies(at 6 and 12 weeks, and at 12 months follow-up)
- Patient satisfaction(at 12 weeks)
- NK-cells(at 3 and 12 weeks)
研究者
Julie Gehl
M.D., Dr. Med. Sci.
Herlev Hospital