Integrative Oncology Approaches for Nerve Damage from Chemotherapy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new methods to help individuals with nerve damage from chemotherapy, focusing on Tai Chi/Qi Gong exercises, α-Lipoic acid (a nutritional supplement), and acupuncture. The researchers aim to determine which treatments or combinations most effectively relieve symptoms like numbness and tingling. Participants will begin with either Tai Chi/Qi Gong or α-Lipoic acid and may try additional treatments like acupuncture if needed. Individuals who have undergone chemotherapy for certain gastrointestinal cancers and experience moderate numbness or tingling might be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for symptom relief.
Do I have to stop taking my current medications for the trial?
The trial does not require you to stop taking your current medications, as long as you have been on them for at least 8 weeks before joining the study and your dose hasn't changed. However, you cannot start new pain medications during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Tai Chi and Qi Gong are generally safe for individuals experiencing nerve problems caused by chemotherapy. These practices are manageable and can improve balance and nerve function in cancer survivors. No major side effects have been reported for patients engaging in these activities.
For α-Lipoic acid (ALA), studies suggest it is also safe to use. Research indicates that ALA can reduce symptoms of nerve problems from chemotherapy without causing major side effects. It acts as an antioxidant, which might help protect nerves during treatment.
Acupuncture, another treatment in this study, has shown safety with no major side effects reported. Research supports its use for relieving symptoms of nerve problems in cancer patients.
Overall, these treatments have been studied and found to be safe, with few reported side effects. Participants can feel reassured about the safety of these options based on existing research.12345Why are researchers excited about this trial's treatments?
Unlike conventional treatments for chemotherapy-induced nerve damage, which often involve medications like gabapentin or duloxetine, these investigational approaches integrate Tai Chi/Qi Gong and α-Lipoic acid (ALA) to potentially alleviate symptoms. Tai Chi/Qi Gong offers a non-pharmaceutical, mind-body approach that promotes relaxation and physical balance, which may reduce nerve pain and improve quality of life. α-Lipoic acid is an antioxidant that could help reduce oxidative stress contributing to nerve damage. The combination of these treatments, along with acupuncture, targets nerve damage from multiple angles, offering a holistic alternative that might improve outcomes without the side effects typical of standard medications. Researchers are excited because these approaches could provide a more natural, multi-faceted way to manage nerve damage, enhancing patient wellness beyond symptom relief.
What evidence suggests that this trial's treatments could be effective for nerve damage from chemotherapy?
This trial will explore integrative oncology approaches for chemotherapy-induced peripheral neuropathy (CIPN). Participants may be assigned to different treatment arms. Research has shown that Tai Chi and Qi Gong, included in some trial arms, can help with CIPN by improving balance, posture, and reducing pain in cancer patients, potentially aiding nerve function. Alpha-lipoic acid (ALA), another treatment option in this trial, was tested and found to lessen the severity of neuropathy symptoms in patients receiving chemotherapy by protecting nerves from damage. Acupuncture, also part of some trial arms, has shown effectiveness in alleviating CIPN symptoms, reducing pain, and improving patients' quality of life. Evidence supports the potential effectiveness of these treatments in managing nerve damage from chemotherapy.34678
Who Is on the Research Team?
Kuang-Yi Wen, PhD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Are You a Good Fit for This Trial?
This trial is for adults with stage I-III gastrointestinal cancer who finished certain chemotherapy drugs at least three months ago and are experiencing moderate numbness or tingling in their hands or feet. Participants must speak English.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Stage 1
Participants receive either Tai Chi/Qi Gong or α-Lipoic acid (ALA) for 8 weeks. Response is assessed at week 8.
Treatment Stage 2
Nonresponders to initial treatment are randomized to combination treatments including Tai Chi/Qi Gong, ALA, and/or acupuncture for an additional 8 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Acupuncture
- Tai Chi/Qi Gong
- α-Lipoic acid
Trial Overview
The study tests if Tai Chi/Qi Gong (done virtually) or alpha-lipoic acid supplements, followed by acupuncture if needed, can help reduce nerve damage symptoms from chemotherapy. Treatments are assigned randomly over a 16-week period.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
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.
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.
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Lead Sponsor
Citations
A Narrative Review of the Efficacy of Acupuncture in ... - PMC
Studies show that twice-weekly sessions for eight weeks improve pain and quality of life in CIPN patients, while a 12-week weekly electro- ...
Effects of acupuncture-related intervention on ...
One study indicated significant improvement in CIPN symptoms after 6 weeks of TEAS, with the most notable enhancements seen in neuropathic, intermittent, and ...
The effectiveness and safety of acupuncture for ...
Two studies revealed that, compared with placebo acupuncture, acupuncture does not reduce chemotherapy-induced neurotoxicity and functional disability (22, 23).
Effectiveness of Acupuncture Treatment on Chemotherapy ...
Our study revealed that acupuncture, as a kind of traditional Chinese therapeutic method, is significantly effective and safe in the treatment of CIPN.
Acupuncture Therapy For The Treatment Of Chemotherapy ...
This case report describes a patient using acupuncture to manage chemotherapy-induced neuropathic pain (CIPN).
The effectiveness and safety of acupuncture for chemotherapy ...
Two studies revealed that, compared with placebo acupuncture, acupuncture does not reduce chemotherapy-induced neurotoxicity and functional disability (22, 23).
Efficacy and safety of acupuncture in the treatment ...
Acupuncture, as a traditional Chinese medical therapy, has demonstrated significant efficacy in improving peripheral neuropathy with no apparent side effects ...
8.
fredhutch.org
fredhutch.org/en/news/center-news/2023/03/chemotherapy-peripheral-neuropathy-cancer.htmlPeripheral neuropathy: When having no pain is a big ...
Fred Hutch doctors are testing acupuncture as a way to ease symptoms of chemotherapy-induced peripheral neuropathy.
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