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.
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,
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,
Sequential
Tai Chi/Qi Gong
BehavioralParticipants 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) Integrated movement.
α- Lipoic acid
Dietary supplementParticipants will be provided with Lipoic Acid Supplement (300 mg) bottles, with instructions to take two tablets daily, 30 minutes before breakfast.
Acupuncture
Procedure/Surgeryparticipants 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 heaviness.
6
Treatment groupsSee each treatment group below.
Consent Rate
Proportion of eligible participants who provide informed consent.
Treatment Adherence
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
Proportion of enrolled participants who complete the final follow-up assessment at the end of the study
Progression to Stage II
Proportion of participants who do not respond to Stage I treatment and undergo re-randomization to Stage II treatment within the SMART design.
Participant Satisfaction
The Client Satisfaction Questionnaire - 8 item version (CSQ-8) is an 8-item standardized measure of global satisfaction with services. Each item is rated on a 4-point Likert scale, and the responses are summed to produce a total score ranging from 8 to 32, where 8 represents the lowest possible satisfaction and 32 represents the highest. Higher CSQ-8 scores indicate greater (better) satisfaction with services received.
Change in Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Change in numbness and tingling severity assessed using the relevant items from the European Organization for Research and Treatment of Cancer Quality of Life - CIPN20 (QLQ-CIPN20) sensory subscale. The QLQ-CIPN20 sensory subscale uses a 1-4 response scale (1 = Not at all, 4 = Very much) for each item, which is then converted to a 0-100 score, where higher values indicate worse sensory neuropathy symptoms. The total sensory score is calculated by averaging the sensory-item responses and applying the standard EORTC symptom-scale transformation, resulting in a score where lower = better outcomes and higher = worse outcomes. A 2.5-5.9-point increase represents a clinically meaningful worsening (MCID) in sensory symptoms.
Change in Falls Efficacy
Short Falls Efficacy Scale-International consists of 7 items covering indoor and outdoor activities. Respondents indicate their level of concern about falling during each activity on a 4-point scale. The Short Falls Efficacy Scale-International is a 7-item self-report measure assessing an individual's concern about falling while performing everyday activities. Each item is rated on a 4-point scale, and responses are summed to produce a total score ranging from 7 to 28, where 7 indicates no concern about falling and 28 indicates severe concern about falling. Higher scores represent a worse outcome, reflecting greater fear of falling and lower falls-related self-efficacy.
Upper Body Physical Function
Upper-body physical function will be assessed using the Grip Strength Test measured with a Jamar Hand Dynamometer, a standardized and widely accepted measure of maximal isometric hand-grip force. Grip strength is recorded in kilograms (kg) or pounds (lb), with a minimum value of 0 (no measurable force) and a maximum measurable value of approximately 90 kg (200 lb) based on the device's calibrated range. Higher grip-strength values indicate a better outcome, reflecting greater upper-extremity muscle strength and functional capacity.
Lower Body Physical Function
physical function will be measured by Chair to Stand (CTS). The Chair-to-Stand (CTS) test is a functional performance measure of lower-body strength and mobility, most commonly administered as the 30-Second Chair Stand Test or the Five-Times Sit-to-Stand Test. In the 30-second version, the score is the number of complete stands performed in 30 seconds, with a minimum value of 0 (unable to rise without arm support) and no fixed maximum, although higher counts reflect better function; higher scores indicate a better outcome, representing greater lower-extremity strength and functional capacity.
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