Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Consent Rate
研究概览
简要总结
The objective of the proposed pilot is to test the feasibility, acceptability, and preliminary efficacy of a 16-week sequential, multiple assessment randomized trial (SMART), which includes virtual Tai Chi/Qi Gong or α- Lipoic acid (ALA) supplements as an initial treatment, and acupuncture as the additional treatment, that examines a stepped-care intervention to address CIPN.
详细描述
This study explores the combined effects of Tai Chi/Qi Gong and Alpha-Lipoic Acid (ALA) on participants over time, with adjustments to treatment based on individual responses. Participants begin the study at baseline and are assessed for their response to either Tai Chi/Qi Gong or ALA at multiple time points-week 8 and week 16, which is the study's conclusion.
At each evaluation point, participants are categorized as having either a sufficient response (≥2-point reduction on the CIPN scale) or an insufficient response (<2-point reduction on the CIPN scale) to the intervention they are receiving (Tai Chi/Qi Gong or ALA). For those who demonstrate a sufficient response to their assigned treatment, they continue with their original intervention throughout the study. However, participants showing insufficient response undergo adjustments in their treatment regimen.
If a participant's response is deemed insufficient, they are assigned to combination treatments aimed at improving outcomes. The possible combinations include:
- Tai Chi/Qi Gong combined with acupuncture
- Tai Chi/Qi Gong and ALA
- ALA combined with acupuncture This dynamic approach allows the study to test not only the individual effects of Tai Chi/Qi Gong and ALA but also their combined impact with acupuncture when participants do not respond adequately to the primary interventions.
The study follows this response-adjusted intervention protocol over the course of 16 weeks, with final assessments made at the end of the study to evaluate the overall efficacy of each treatment pathway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:
- •Age 18 years or older,
- •Self-reported moderate (≥ 2/4) numbness and tingling on the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Numbness and Tingling Severity Item in the previous week,
- •At least three months since the last receipt of neurotoxic chemotherapy,
- •Prior receipt of paclitaxel, docetaxel, cisplatin, oxaliplatin, nab-paclitaxel, or carboplatin for the treatment of stage I-III Gastrointestinal (GI) cancers,
- •Speaking/reading English.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Prognosis of ≤ 3 months,
- •Documented neuropathy attributed to other causes (e.g., diabetic neuropathy),
- •Intention to initiate a new prescription of duloxetine or other pain medications (i.e., first-line treatment for CIPN pain) during the study period; however, participants may continue on duloxetine or other pain medications if initiated at least 8 weeks before study enrollment, with no change in dose, and reporting unmanaged CIPN (i.e., ≥ 2/4) PRO-CTCAE numbness/tingling severity in the last week,
- •Currently using alcohol (ethyl), which means regular alcohol consumption (defined as ≥7 drinks/week for women, ≥14 drinks/week for men, or binge drinking >3 drinks per occasion at least weekly) within the past 3 months, or current alcohol use disorder or inability/unwillingness to abstain from alcohol during the study intervention period,
- •Currently using calcium salts, iron preparations or magnesium salts orally,
- •With thyroid disorders, particularly those with hypo- or hyperthyroidism,
- •With thiamine deficiency, as assessed and verified by the physician.
研究组 & 干预措施
Arm 1: Tai Chi/Qi Gong Alone
This arm includes participants who respond to Tai Chi/Qi Gong in Stage 1. In Stage 2, participants attended Tai Chi/Qi Gong sessions twice weekly for 8 weeks. Using a manualized approach, each class will provide objectives and learning activities related to sequentially learning a specific set of Tai Chi/Qi Gong movements weekly.
干预措施: Tai Chi/Qi Gong (Behavioral)
Arm 2: Tai Chi/Qi Gong plus α- Lipoic acid (ALA)
This arm includes participants who do no respond to Tai Chi/Qi Gong in Stage 1. In Stage 1, participants attend Tai Chi/Qi Gong sessions twice weekly for 8 weeks. In Stage 2, nonresponders to Tai Chi/Qi Gong continue Tai Chi/Qi Gong and are randomized to receive daily alpha-lipoic acid (ALA) supplementation for 8 weeks.
干预措施: α- Lipoic acid (Dietary Supplement)
Arm 6: α- Lipoic acid (ALA) plus Acupuncture
This arm includes participants who do no respond to alpha-lipoic acid (ALA) in Stage 1. In Stage 1, participants receive oral alpha-lipoic acid (ALA) supplementation for 8 weeks. In Stage 2, nonresponders to ALA continue ALA supplementation and are randomized to receive acupuncture treatments for 8 weeks.
干预措施: Acupuncture (Procedure)
Arm 2: Tai Chi/Qi Gong plus α- Lipoic acid (ALA)
This arm includes participants who do no respond to Tai Chi/Qi Gong in Stage 1. In Stage 1, participants attend Tai Chi/Qi Gong sessions twice weekly for 8 weeks. In Stage 2, nonresponders to Tai Chi/Qi Gong continue Tai Chi/Qi Gong and are randomized to receive daily alpha-lipoic acid (ALA) supplementation for 8 weeks.
干预措施: Tai Chi/Qi Gong (Behavioral)
Arm 3: Tai Chi/Qi Gong plus Acupuncture
This arm includes participants who do no respond to Tai Chi/Qi Gong in Stage 1. In Stage 1, participants attend Tai Chi/Qi Gong sessions twice weekly for 8 weeks. In Stage 2, nonresponders to Tai Chi/Qi Gong continue Tai Chi/Qi Gong and are randomized to receive acupuncture treatments for 8 weeks.
干预措施: Tai Chi/Qi Gong (Behavioral)
Arm 3: Tai Chi/Qi Gong plus Acupuncture
This arm includes participants who do no respond to Tai Chi/Qi Gong in Stage 1. In Stage 1, participants attend Tai Chi/Qi Gong sessions twice weekly for 8 weeks. In Stage 2, nonresponders to Tai Chi/Qi Gong continue Tai Chi/Qi Gong and are randomized to receive acupuncture treatments for 8 weeks.
干预措施: Acupuncture (Procedure)
Arm 4: α- Lipoic acid (ALA) Alone
This arm includes participants who respond to alpha-lipoic acid (ALA) in Stage 1. In Stage 1, participants receive oral alpha-lipoic acid (ALA) supplementation daily for 8 weeks. In Stage 2, responders to ALA continue daily ALA supplementation for an additional 8 weeks.
干预措施: α- Lipoic acid (Dietary Supplement)
Arm 5: α- Lipoic acid (ALA) plus Tai Chi/Qi Gong
This arm includes participants who do no respond to alpha-lipoic acid (ALA) in Stage 1. In Stage 1, participants receive oral alpha-lipoic acid (ALA) supplementation for 8 weeks. In Stage 2, nonresponders to ALA continue ALA supplementation and are randomized to receive Tai Chi/Qi Gong sessions twice weekly for 8 weeks.
干预措施: Tai Chi/Qi Gong (Behavioral)
Arm 5: α- Lipoic acid (ALA) plus Tai Chi/Qi Gong
This arm includes participants who do no respond to alpha-lipoic acid (ALA) in Stage 1. In Stage 1, participants receive oral alpha-lipoic acid (ALA) supplementation for 8 weeks. In Stage 2, nonresponders to ALA continue ALA supplementation and are randomized to receive Tai Chi/Qi Gong sessions twice weekly for 8 weeks.
干预措施: α- Lipoic acid (Dietary Supplement)
Arm 6: α- Lipoic acid (ALA) plus Acupuncture
This arm includes participants who do no respond to alpha-lipoic acid (ALA) in Stage 1. In Stage 1, participants receive oral alpha-lipoic acid (ALA) supplementation for 8 weeks. In Stage 2, nonresponders to ALA continue ALA supplementation and are randomized to receive acupuncture treatments for 8 weeks.
干预措施: α- Lipoic acid (Dietary Supplement)
结局指标
主要结局
Consent Rate
时间窗: Up to 2 years
Proportion of eligible participants who provide informed consent.
Treatment Adherence
时间窗: 16 weeks
Proportion of prescribed intervention activities completed, including attendance at Tai Chi/Qi Gong or acupuncture sessions and adherence to alpha-lipoic acid (ALA) supplementation.
Retention Rate
时间窗: 16 weeks
Proportion of enrolled participants who complete the final follow-up assessment at the end of the study
Progression to Stage II
时间窗: 8 weeks
Proportion of participants who do not respond to Stage I treatment and undergo re-randomization to Stage II treatment within the SMART design.
次要结局
- Participant Satisfaction(16 weeks)