Recruiting

Tai Chi/Qi Gong, ALA, Acupuncture

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Code:

NCT07501663

Conditions

Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tai Chi/Qi Gong

α- Lipoic acid

Acupuncture

Study Details

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

Study ID

NCT07501663

Start date

Jan 20, 2026

Status verified date

Apr, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm 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.

experimental: Arm 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.

experimental: Arm 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.

experimental: Arm 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.

experimental: Arm 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.

experimental: Arm 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.

Interventions

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

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

Primary outcome measure

  • Consent Rate [ Time Frame: Up to 2 years ]
  • Treatment Adherence [ Time Frame: 16 weeks ]
  • Retention Rate [ Time Frame: 16 weeks ]
  • Progression to Stage II [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Kuang-Yi Wen, PhD

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

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Kuang-Yi Wen, MD

2155034623Kuang-Yi.Wen@Jefferson.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University on 2026-04-14.