Improving Chemotherapy-induced Peripheral Neuropathy in Cancer Patients Using a Combined Qigong Baduanjin and Self-administered Acupressure Intervention: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in self-reported CIPN severity post-intervention
研究概览
简要总结
The objective of the study is to investigate the effects of a 16-week combined qigong and acupressure intervention on reducing self-reported chemotherapy-induced peripheral neuropathy (CIPN) severity, objective measures of CIPN severity, lower-extremity functioning, handgrip strength, fall incidence, and health-related quality of life post-intervention among post-chemotherapy adult cancer patients. This will be a 2-arm assessor-blinded randomized controlled trial that will follow the CONSORT guidelines. A total of 104 cancer patients aged ≥18 who have completed neurotoxic chemotherapy at least 1 month prior to enrolment and experiencing CIPN will be recruited and randomized into combined qigong and self-administered acupressure intervention and wait-list control groups. The intervention group comprises of twice-weekly supervised group sessions and three times-weekly self-practice prescription (30 min each time) on days without group sessions. The control group will be offered a free modality of their choice after the last follow-up. The participants will receive usual care alone during the study period.
详细描述
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common side effects of chemotherapy experiencing by cancer patients. CIPN can lead to significant distress, diminished health-related quality of life, functional decline, and an increased risk of falls in cancer patients, as they may experience altered proprioception. CIPN may continue to progress for several months post-treatment or even persist for years following chemotherapy.
Current pharmacological approaches are limited not only by side effects (e.g., fatigue, dizziness, insomnia, or nausea) but also by patients' unwillingness to further medicate a drug-related side effect. Also, the drugs may treat pain but not non-painful CIPN symptoms, and cannot induce neuro-protection or neuro-regeneration. Non-pharmacological interventions may be more appealing to patients, as they usually have no side effects and may result in clinical benefits for CIPN sufferers.
Acupressure is a non-invasive variant of acupuncture both adopting the meridian theory of traditional Chinese medicine (TCM) that stimulate acupoints across meridians and facilitate the flow of qi (energy) and blood, thereby restoring health and treating disease. Qigong is a mind-body exercise also rooted in the meridian theory of TCM. Through a combination of movement, breath control, and meditation, meridians can be opened, and the flow of qi and blood stimulated, to restore health. The combination approach is likely to elicit complementary physiologic adaptations on mechanisms involving both the peripheral and central nervous systems, thereby inducing a larger and potentially clinically meaningful improvement on CIPN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
An independent randomizer will prepare a computer-generated list of random assignments in sealed, sequentially numbered opaque envelopes. To aid allocation concealment, permuted blocks of varying sizes with an allocation weight of 1:1 will be used. The randomizer will keep a secure copy of the randomization list, which will be concealed from all research personnel and participants. The statistician performing data analysis will be blinded. Although it is not feasible to blind the participants or intervention personnel to the group assignments, the outcome assessors will be blinded.
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
- •≥18 years
- •diagnosis of cancer
- •completed neurotoxic chemotherapy at least 1 month prior to enrolment
- •experiencing CIPN (defined as tingling, numbness, or pain in the extremities in the past week, on the basis of a score ≥4 on an 11-point numerical rating scale due to receiving neurotoxic chemotherapy)
- •Eastern Cooperative Oncology Group performance status between 0 and 2
- •able to communicate in Cantonese or Mandarin
排除标准
- •they have psychiatric disorders or conditions that preclude practicing qigong or acupressure (e.g., recent myocardial infarction, breathing difficulties requiring oxygen use or hospitalization, cannot walk independently)
- •have regularly engaged in qigong or acupressure (>once per week) in the previous 6 months
- •are receiving acupuncture
- •are pregnant or lactating
- •have any infection/injury/ulcers around the acupoints, or had peripheral neuropathy before chemotherapy
结局指标
主要结局
Change in self-reported CIPN severity post-intervention
时间窗: Change from baseline (week 0) to post-intervention (week 16)
The 11-item version of Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG Ntx) subscale will be used. It covers four domains: sensory, motor, hearing, and dysfunction. Items are rated on a scale of 0 (not at all) to 4 (very much), with higher scores indicating more severe CIPN. The Chinese version of FACT/GOG-Ntx has demonstrated satisfactory reliability and validity.
次要结局
- Handgrip strength(Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28))
- Fall incidence(post-intervention (week 16), 12 weeks after the intervention ends (week 28))
- Global health-related quality of life (HRQoL)(Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28))
- Change in self-reported CIPN severity at follow-up(Change from baseline to 12 weeks after the intervention ends (week 28))
- Lower-extremity physical functioning(Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28))
- Objective CIPN severity(Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28))
研究者
Cheung Shuk-Ting
Assistant Professor
The University of Hong Kong