An interventional study of Tai Chi/Qi Gong and α- Lipoic acid in Peripheral Neuropathy, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Not applicable, Interventional, and Supportive care
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.
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:
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.
476 studies on the registry are indexed under Peripheral Nervous System Diseases; 103 are open to participants now.
This study's planned enrollment of 60 is close to the median of 57 across 359 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University is the lead sponsor of 41 studies on the registry; 3 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 14 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Tai Chi/Qi Gong
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.
Behavioral: Tai Chi/Qi Gong · Dietary Supplement: α- Lipoic acid
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.
Behavioral: Tai Chi/Qi Gong · Procedure: Acupuncture
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.
Dietary Supplement: α- Lipoic acid
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.
Behavioral: Tai Chi/Qi Gong · Dietary Supplement: α- Lipoic acid
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.
Dietary Supplement: α- Lipoic acid · Procedure: Acupuncture
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) Integrated movement.
Participants will be provided with Lipoic Acid Supplement (300 mg) bottles, with instructions to take two tablets daily, 30 minutes before breakfast.
Also known as: ALA
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 heaviness.
Consent Rate
Proportion of eligible participants who provide informed consent.
Time frame: Up to 2 years
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.
Time frame: 16 weeks
Retention Rate
Proportion of enrolled participants who complete the final follow-up assessment at the end of the study
Time frame: 16 weeks
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.
Time frame: 8 weeks
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.
Time frame: 16 weeks
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.
Time frame: From Baseline to Week 16 (about 4 months)
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.
Time frame: Baseline to Week 16
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.
Time frame: Baseline to Week 17
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.
Time frame: Baseline to Week 18
Started Jan 2026 (actual). Primary completion is estimated for Apr 2027, 15 months after the start.
Of 122 non-industry interventional studies with no phase under Peripheral Nervous System Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 15 months is below that.
Counting every sponsor, half of 132 studies reached it within 25 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University