Peripheral NeuropathyNCT07501663
Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study
A study testing Tai Chi/Qi Gong, α- Lipoic acid and Acupuncture in people with Peripheral Neuropathy, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Tai Chi/Qi Gong, α- Lipoic acid and Acupuncture
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Kuang-Yi Wen, MD, 2155034623, Kuang-Yi.Wen@Jefferson.edu
About this study
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.
Read the 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 as having either a sufficient response (≥2-point reduction on the CIPN scale) or an insufficient response (<2-point reduction on the CIPN scale) to the intervention they are receiving (Tai Chi/Qi Gong or ALA). For those who demonstrate a sufficient response to their assigned treatment, they continue with their original intervention throughout the study. However, participants showing insufficient response undergo adjustments in their treatment regimen.
If a participant's response is deemed insufficient, they are assigned to combination treatments aimed at improving outcomes. The possible combinations include:
- Tai Chi/Qi Gong combined with acupuncture
- Tai Chi/Qi Gong and ALA
- ALA combined with acupuncture This dynamic approach allows the study to test not only the individual effects of Tai Chi/Qi Gong and ALA but also their combined impact with acupuncture when participants do not respond adequately to the primary interventions.
The study follows this response-adjusted intervention protocol over the course of 16 weeks, with final assessments made at the end of the study to evaluate the overall efficacy of each treatment pathway.
Tai Chi/Qi Gong arm: Participants will undertake an 8-week virtual Tai Chi/Qi Gong program consisting of online classes for 1 hour, twice a week. 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 weekly verification of skills attainment. Six key elements will be emphasized: 1) Mindfulness; 2) Postural alignment; 3) Natural breathing; 4) Active relaxation, 5) Slow movement, and 6) Integrated movement.
ALA arm: Participants will have daily intake of 600 mg of ALA supplement, with instructions with food.
Acupuncture arm: Participants will receive acupuncture treatments for 8 weeks. After disinfecting the skin with an alcohol swab, acupuncturists will insert filiform 0.16 mm × 15 mm (or 30 mm) sterilized, disposable acupuncture needles in the ear and Ba Feng points. Additionally, 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 minutes after achieving de qi, a sensation of achiness, soreness, and heaviness.
- Conditions
- Peripheral Neuropathy
- Being tested
- Tai Chi/Qi Gong, α- Lipoic acid, Acupuncture
- Keywords
- Gastrointestinal, Peripheral Neuropathy in Gastrointestinal, Chemotherapy-induced Peripheral Neuropathy, CIPN, Tai Chi, ALA, Qi Gong, Acupuncture, SMART
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi/Qi GongBehavioural
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 acidDietary supplement
Also called ALA
Participants will be provided with Lipoic Acid Supplement (300 mg) bottles, with instructions to take two tablets daily, 30 minutes before breakfast.
AcupunctureProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: α- Lipoic acid; Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent Rate
Proportion of eligible participants who provide informed consent.
Measured: 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.
Measured: 16 weeks
Retention Rate
Proportion of enrolled participants who complete the final follow-up assessment at the end of the study
Measured: 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.
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start20 Jan 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang-Yi Wen, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501663
- Sponsor's protocol ID
- iRISID-2025-0254
- Other IDs
- JT 44722
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study
- ClinicalTrials.gov ID
- NCT07501663
- Acronym / sponsor ID
- iRISID-2025-0254
- Conditions
- Peripheral Neuropathy
- Keywords
- Gastrointestinal, Peripheral Neuropathy in Gastrointestinal, Chemotherapy-induced Peripheral Neuropathy, CIPN, Tai Chi, ALA, Qi Gong, Acupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 as having either a sufficient response (≥2-point reduction on the CIPN scale) or an insufficient response (<2-point reduction on the CIPN scale) to the intervention they are receiving (Tai Chi/Qi Gong or ALA). For those who demonstrate a sufficient response to their assigned treatment, they continue with their original intervention throughout the study. However, participants showing insufficient response undergo adjustments in their treatment regimen.
If a participant's response is deemed insufficient, they are assigned to combination treatments aimed at improving outcomes. The possible combinations include:
- Tai Chi/Qi Gong combined with acupuncture
- Tai Chi/Qi Gong and ALA
- ALA combined with acupuncture This dynamic approach allows the study to test not only the individual effects of Tai Chi/Qi Gong and ALA but also their combined impact with acupuncture when participants do not respond adequately to the primary interventions.
The study follows this response-adjusted intervention protocol over the course of 16 weeks, with final assessments made at the end of the study to evaluate the overall efficacy of each treatment pathway.
Tai Chi/Qi Gong arm: Participants will undertake an 8-week virtual Tai Chi/Qi Gong program consisting of online classes for 1 hour, twice a week. 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 weekly verification of skills attainment. Six key elements will be emphasized: 1) Mindfulness; 2) Postural alignment; 3) Natural breathing; 4) Active relaxation, 5) Slow movement, and 6) Integrated movement.
ALA arm: Participants will have daily intake of 600 mg of ALA supplement, with instructions with food.
Acupuncture arm: Participants will receive acupuncture treatments for 8 weeks. After disinfecting the skin with an alcohol swab, acupuncturists will insert filiform 0.16 mm × 15 mm (or 30 mm) sterilized, disposable acupuncture needles in the ear and Ba Feng points. Additionally, 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 minutes after achieving de qi, a sensation of achiness, soreness, and heaviness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Tai Chi/Qi Gong Alone | Experimental | Behavioral: Tai Chi/Qi GongThis 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. |
| Arm 2: Tai Chi/Qi Gong plus α- Lipoic acid (ALA) | Experimental | Behavioral: Tai Chi/Qi Gong, Dietary Supplement: α- Lipoic acidThis 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. |
| Arm 3: Tai Chi/Qi Gong plus Acupuncture | Experimental | Behavioral: Tai Chi/Qi Gong, Procedure: AcupunctureThis 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. |
| Arm 4: α- Lipoic acid (ALA) Alone | Experimental | Dietary Supplement: α- Lipoic acidThis 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. |
| Arm 5: α- Lipoic acid (ALA) plus Tai Chi/Qi Gong | Experimental | Behavioral: Tai Chi/Qi Gong, Dietary Supplement: α- Lipoic acidThis 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. |
| Arm 6: α- Lipoic acid (ALA) plus Acupuncture | Experimental | Dietary Supplement: α- Lipoic acid, Procedure: AcupunctureThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:
Key exclusion criteria (8 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi/Qi GongParticipants 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. | Behavioural | 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 acidAlso: ALAParticipants will be provided with Lipoic Acid Supplement (300 mg) bottles, with instructions to take two tablets daily, 30 minutes before breakfast. | Dietary supplement | 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 |
| Acupunctureparticipants 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. | Procedure or surgery | Arm 3: Tai Chi/Qi Gong plus Acupuncture, Arm 6: α- Lipoic acid (ALA) plus Acupuncture |
Primary outcome
Consent Rate
Time frame: Up to 2 years
Proportion of eligible participants who provide informed consent.
Treatment Adherence
Time frame: 16 weeks
Proportion of prescribed intervention activities completed, including attendance at Tai Chi/Qi Gong or acupuncture sessions and adherence to alpha-lipoic acid (ALA) supplementation.
Retention Rate
Time frame: 16 weeks
Proportion of enrolled participants who complete the final follow-up assessment at the end of the study
Progression to Stage II
Time frame: 8 weeks
Proportion of participants who do not respond to Stage I treatment and undergo re-randomization to Stage II treatment within the SMART design.
1 secondary outcome
Participant Satisfaction
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kuang-Yi Wen, PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi/Qi Gong, α- Lipoic acid and Acupuncture in people with Peripheral Neuropathy, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kuang-Yi Wen, PhD (215-503-4623, Kuang-Yi.Wen@Jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent Rate (time frame: Up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.