Tai Chi, alpha-lipoic acid, and acupuncture to reduce chemotherapy-related peripheral neuropathy in people treated for gastrointestinal cancers.
Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study
NA · Thomas Jefferson University · NCT07501663
This 16-week pilot will try virtual Tai Chi/Qi Gong or alpha-lipoic acid, adding acupuncture for those who don't improve, to see if these approaches reduce chemo-related nerve numbness and tingling in people treated for GI cancers.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07501663 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) who speak/read English, have moderate (≥2/4) recent numbness and tingling, completed neurotoxic chemotherapy at least three months prior for stage I–III GI cancers (e.g., taxanes, platinum agents), and can join virtual sessions and site visits.
Not a fit: Patients with neuropathy attributed to other causes (such as diabetic neuropathy), those with prognosis ≤3 months, those within three months of neurotoxic chemotherapy, or those unable to participate in virtual movement sessions or onsite acupuncture are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce numbness and tingling and improve daily function using non-drug and supplement options.
How similar studies have performed: Prior studies have shown some benefit of Tai Chi, acupuncture, and ALA for neuropathy or related symptoms, but using a response-adaptive SMART design to combine these options is novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Neuropathy, Gastrointestinal, Peripheral Neuropathy in Gastrointestinal, Chemotherapy-induced Peripheral Neuropathy, CIPN, Tai Chi, ALA, Qi Gong