Tai Chi, alpha-lipoic acid, and acupuncture to reduce chemotherapy-related peripheral neuropathy in people treated for gastrointestinal cancers.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot uses a sequential, multiple-assignment randomized (SMART) design over 16 weeks to test initial treatments of virtual Tai Chi/Qi Gong versus alpha-lipoic acid (ALA). Participants are assessed at baseline, week 8, and week 16 and are classified as responders or non-responders based on a ≥2-point change on a CIPN scale. Responders continue their initial intervention, while non-responders are re-randomized to combination approaches that add acupuncture or combine the two initial therapies. The study measures feasibility, acceptability, and preliminary symptom change to inform larger trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sidney Kimmel Cancer Center at Thomas Jefferson University
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Kuang-Yi Wen, PhD — Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
• Study coordinator: Kuang-Yi Wen, PhD
• Email: Kuang-Yi.Wen@Jefferson.edu
• Phone: 215-503-4623

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.