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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT07501663
Status
Recruiting
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Conditions

  • Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 20, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Consent Rate [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Kuang-Yi Wen, MD
[email protected]
2155034623

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