NCT00077090Unknown2 期
Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
Institute of Cancer Research, United Kingdom10 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 63
- 试验地点
- 10
- 主要终点
- Volume of the affected limb, expressed as a percentage of the contralateral limb Volume on the day of measurement, as measured by perometer 12 months after baseline assessment
研究概览
简要总结
RATIONALE: Hyperbaric oxygen therapy may be effective in repairing damaged tissue and reducing lymphedema caused by radiation therapy for cancer.
PURPOSE: This randomized phase II trial is studying hyperbaric oxygen to see how well it works compared to standard therapy in treating chronic arm lymphedema in patients who have undergone radiation therapy for cancer.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of hyperbaric oxygen (HBO) therapy vs standard management, in terms of reduction of lymphedema, in patients with chronic arm lymphedema after radiotherapy for cancer.
Secondary
- Determine the mechanisms of tissue reperfusion and healing in patients treated with HBO therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
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
- •DISEASE CHARACTERISTICS:
- •History of early breast cancer (T1-3, N0-1, M0)
- •Prior breast surgery with or without axillary dissection
- •Prior breast/chest wall radiotherapy with or without radiotherapy to the supraclavicular fossa and/or axilla, completed at least 2 years ago
- •Arm lymphedema
- •At least 15% increase in arm volume
- •No evidence of cancer recurrence
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Female or male
- •Menopausal status
- •Not specified
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •No chronic obstructive airway disease
- •No bullous lung disease
- •No acute or chronic pulmonary infection
- •No uncontrolled asthma
- •No untreated pneumothorax
- •Physically and psychologically fit for HBO therapy
- •No claustrophobia
- •No epilepsy
- •No eustachian tube dysfunction
- •No recurrent attacks of vertigo
- •No contraindication to MRI (e.g., intracranial ferrous material)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •See Disease Characteristics
- •No prior ear operations
- •No prior hyperbaric oxygen (HBO) therapy, except as treatment for decompression illness
排除标准
- 未提供
结局指标
主要结局
Volume of the affected limb, expressed as a percentage of the contralateral limb Volume on the day of measurement, as measured by perometer 12 months after baseline assessment
次要结局
- Patient self-assessments, using specific quality of life scale in upper limb lymphoedema and the UK SF-36 Health Survey Questionnaire, at 3, 6, 9 and 12 months after baseline assessment
- 99Tc-nanocolloid clearance rate as measured by quantitative lymphoscintigraphy 12 months after baseline assessment
- Extracellular water content as measured by EdemaMeter (bioimpedance measurements) 12 months after baseline assessment
研究者
研究点 (10)
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