NCT07501663 Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study
| NCT ID | NCT07501663 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
| Condition | Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-01-20 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Kuang-Yi Wen, PhD
PRINCIPAL INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Frequently Asked Questions
Who can join the NCT07501663 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07501663 currently recruiting?
Yes, NCT07501663 is actively recruiting participants. Contact the research team at Kuang-Yi.Wen@Jefferson.edu for enrollment information.
Where is the NCT07501663 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07501663 clinical trial?
NCT07501663 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The principal investigator is Kuang-Yi Wen, PhD at Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The trial plans to enroll 60 participants.