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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Neuropathy
• Intervention / Treatment: Behavioral: Tai Chi/Qi Gong; Dietary supplement: α- Lipoic acid; Procedure: Acupuncture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kuang-Yi Wen, PhD; Phone Number: 215-503-4623; Email: Kuang-Yi.Wen@Jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Sidney Kimmel Cancer Center at Thomas Jefferson University
      • Contact: Kuang-Yi Wen, MD; Phone Number: 2155034623; Email: Kuang-Yi.Wen@Jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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) Integrated movement.
Experimental: 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.	Behavioral: 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) Integrated movement.; Dietary supplement: 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.; Other Names: ALA
Experimental: 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.	Behavioral: 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) Integrated movement.; Procedure: 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 heaviness.
Experimental: 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.	Dietary supplement: 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.; Other Names: ALA
Experimental: 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.	Behavioral: 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) Integrated movement.; Dietary supplement: 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.; Other Names: ALA
Experimental: 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.	Dietary supplement: 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.; Other Names: ALA; Procedure: 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 heaviness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consent Rate	Proportion of eligible participants who provide informed consent.	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.	16 weeks
Retention Rate	Proportion of enrolled participants who complete the final follow-up assessment at the end of the study	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline to Week 18

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Kuang-Yi Wen, PhD, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Acupuncture; Tai Chi; Gastrointestinal; SMART; CIPN; ALA; Qi Gong; Chemotherapy-induced Peripheral Neuropathy; Peripheral Neuropathy in Gastrointestinal
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Sulfur Compounds; Organic Chemicals; Therapeutics; Fatty Acids; Lipids; Complementary Therapies; Carboxylic Acids; Enzymes and Coenzymes; Coenzymes; Thiophenes; Thioctic Acid; Acupuncture Therapy
• Other Study ID Numbers: iRISID-2025-0254; JT 44722 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No