Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study

Обзор

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.

Подробное описание

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.

Tai Chi/Qi Gong arm: Participants will undertake an 8-week virtual Tai Chi/Qi Gong program consisting of online classes for 1 hour, twice a week. 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, with weekly verification of skills attainment. Six key elements will be emphasized: 1) Mindfulness; 2) Postural alignment; 3) Natural breathing; 4) Active relaxation, 5) Slow movement, and 6) Integrated movement.

ALA arm: Participants will have daily intake of 600 mg of ALA supplement, with instructions with food.

Acupuncture arm: Participants will receive acupuncture treatments for 8 weeks. After disinfecting the skin with an alcohol swab, acupuncturists will insert filiform 0.16 mm × 15 mm (or 30 mm) sterilized, disposable acupuncture needles in the ear and Ba Feng points. Additionally, 0.20 mm × 30 mm (or 40 mm) sterilized, disposable acupuncture needles will be inserted at body points. Needles for body points will be inserted 0.5 inches into the skin and left for 30 minutes after achieving de qi, a sensation of achiness, soreness, and heaviness.

Вмешательства

• Поведенческое Tai Chi/Qi Gong
  Participants will be asked to attend Tai Chi/Qi Gong classes for one hour twice a week for 8 weeks over Zoom video conferencing or in person. 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 with verification of skills attainment weekly24. Six key elements will be emphasized: 1) Mindfulness; 2) Postural alignment; 3) Natural breathing; 4) Active relaxation, 5) Slow movement, and 6)
• Пищевая добавка α- Lipoic acid
  Participants will be provided with Lipoic Acid Supplement (300 mg) bottles, with instructions to take two tablets daily, 30 minutes before breakfast.
• Процедура Acupuncture
  participants will receive acupuncture treatments for 8 weeks. After disinfecting the skin with an alcohol swab, acupuncturists inserted filiform 0.16 mm × 15 mm (or 30 mm) sterilized, disposable acupuncture needles in the ear and Ba Feng points; 0.20 mm × 30 mm (or 40 mm) sterilized, disposable acupuncture needles will be inserted at body points. Needles for body points will be inserted 0.5 inches into the skin and left for 30 min after achieving de qi, a sensation of achiness, soreness and heav

Первичные конечные точки

• Consent Rate [Срок оценки: Up to 2 years]
• Treatment Adherence [Срок оценки: 16 weeks]
• Retention Rate [Срок оценки: 16 weeks]
• Progression to Stage II [Срок оценки: 8 weeks]

Вторичные конечные точки (1)

• Participant Satisfaction [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia

Идентификаторы

NCT: NCT07501663 · iRISID-2025-0254 · JT 44722

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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