Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study
United States60 participantsStarted 2026-01-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) …
What they're measuring
1
Consent Rate
Timeframe: Up to 2 years
2
Treatment Adherence
Timeframe: 16 weeks
3
Retention Rate
Timeframe: 16 weeks
4
Progression to Stage II
Timeframe: 8 weeks
Trial details
NCT IDNCT07501663
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University