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Clinical Trial NCT07501663 for Peripheral Neuropathy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study 60 Randomized Virtual
Clinical Trial NCT07501663 is an interventional study for Peripheral Neuropathy that is recruiting. It started on January 20, 2026 with plans to enroll 60 participants. Led by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, it is expected to complete by April 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
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.
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 a...
Show MoreOfficial Title
Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study
Conditions
Peripheral NeuropathyOther Study IDs
- iRISID-2025-0254
- JT 44722 (Other Identifier) (JeffTrial Number)
NCT ID Number
Start Date (Actual)
2026-01-20
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-04
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Gastrointestinal
Peripheral Neuropathy in Gastrointestinal
Chemotherapy-induced Peripheral Neuropathy
CIPN
Tai Chi
ALA
Qi Gong
Acupuncture
SMART
Peripheral Neuropathy in Gastrointestinal
Chemotherapy-induced Peripheral Neuropathy
CIPN
Tai Chi
ALA
Qi Gong
Acupuncture
SMART
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalArm 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. | 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...Show More |
ExperimentalArm 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. | 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...Show More 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. |
ExperimentalArm 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. | 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...Show More 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 l...Show More |
ExperimentalArm 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. | 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. |
ExperimentalArm 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. | 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...Show More 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. |
ExperimentalArm 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. | 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. 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 l...Show More |
Primary Outcome Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
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.
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.
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityStudy Central Contact
Contact: Kuang-Yi Wen, PhD, 215-503-4623, [email protected]
1 Study Locations in 1 Countries
Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States
Kuang-Yi Wen, MD, Contact, 2155034623, [email protected]
Recruiting