Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study

NCT07501663 | Recruiting

• 2 other identifiers: iRISID-2025-0254JT 44722
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy

Keywords

Gastrointestinal; Peripheral Neuropathy in Gastrointestinal; Chemotherapy-induced Peripheral Neuropathy; CIPN; Tai Chi; ALA; Qi Gong; Acupuncture; SMART

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Participant Satisfaction

  16 weeks

Other Outcomes (4)

• Change in Chemotherapy-Induced Peripheral Neuropathy (CIPN)

  From Baseline to Week 16 (about 4 months)

• Change in Falls Efficacy

  Baseline to Week 16

• Upper Body Physical Function

  Baseline to Week 17

Study Arms (6)

Arm 1: Tai Chi/Qi Gong Alone

EXPERIMENTAL

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.

Behavioral: Tai Chi/Qi Gong

Arm 2: Tai Chi/Qi Gong plus α- Lipoic acid (ALA)

EXPERIMENTAL

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.

Behavioral: Tai Chi/Qi Gong; Dietary Supplement: α- Lipoic acid

Arm 3: Tai Chi/Qi Gong plus Acupuncture

EXPERIMENTAL

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.

Behavioral: Tai Chi/Qi Gong; Procedure: Acupuncture

Arm 4: α- Lipoic acid (ALA) Alone

EXPERIMENTAL

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.

Dietary Supplement: α- Lipoic acid

Arm 5: α- Lipoic acid (ALA) plus Tai Chi/Qi Gong

EXPERIMENTAL

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.

Behavioral: Tai Chi/Qi Gong; Dietary Supplement: α- Lipoic acid

Arm 6: α- Lipoic acid (ALA) plus Acupuncture

EXPERIMENTAL

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.

Dietary Supplement: α- Lipoic acid; Procedure: Acupuncture

Interventions

Tai Chi/Qi Gong BEHAVIORAL

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 alignment; 3) Natural breathing; 4) Active relaxation, 5) Slow movement, and 6) Integrated movement.

Arm 1: Tai Chi/Qi Gong Alone; Arm 2: Tai Chi/Qi Gong plus α- Lipoic acid (ALA); Arm 3: Tai Chi/Qi Gong plus Acupuncture; Arm 5: α- Lipoic acid (ALA) plus Tai Chi/Qi Gong

α- Lipoic acid DIETARY_SUPPLEMENT

Participants will be provided with Lipoic Acid Supplement (300 mg) bottles, with instructions to take two tablets daily, 30 minutes before breakfast.

Also known as: ALA

Arm 2: Tai Chi/Qi Gong plus α- Lipoic acid (ALA); Arm 4: α- Lipoic acid (ALA) Alone; Arm 5: α- Lipoic acid (ALA) plus Tai Chi/Qi Gong; Arm 6: α- Lipoic acid (ALA) plus Acupuncture

Acupuncture PROCEDURE

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 left for 30 min after achieving de qi, a sensation of achiness, soreness and heaviness.

Arm 3: Tai Chi/Qi Gong plus Acupuncture; Arm 6: α- Lipoic acid (ALA) plus Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Thioctic Acid; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Complementary Therapies; Therapeutics

Study Officials

• Kuang-Yi Wen, PhD

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuang-Yi Wen, PhD

CONTACT

215-503-4623; Kuang-Yi.Wen@Jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)