Green Tea Extract for Cancer-Related Nerve Pain

(GTE Trial)

MD
Overseen ByMichael Daniel, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Alabama at Birmingham

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether green tea extract can reduce nerve pain in cancer survivors receiving supportive care. Researchers aim to determine if daily green tea extract can lessen this pain compared to a placebo (a substance with no active treatment). The trial targets individuals with cancer-related nerve pain whose pain management has remained stable recently. Those who do not regularly consume large amounts of green tea and are not allergic to rice may qualify. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must have a stable pain management regimen with no more than a 10% change in dosage in the 14 days before joining.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that green tea extract (GTE) might protect the brain and nerves. Some studies suggest it can aid in healing nerve injuries. However, reports have noted mild to moderate side effects, such as stomach issues, headaches, and heart-related problems. These side effects were usually mild and resolved after stopping the treatment. It's important to note that this treatment remains in the early stages of testing. While some evidence indicates it is safe, more research is needed to fully understand its effects.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cancer-related nerve pain, which often include medications like opioids or anticonvulsants, the green tea extract being studied is derived from a natural source: the decaffeinated green tea leaf. Researchers are excited because this extract may offer pain relief without the side effects commonly associated with current medications, such as drowsiness or addiction potential. Additionally, green tea is known for its antioxidant properties, which could provide added benefits in managing nerve pain associated with cancer.

What evidence suggests that green tea extract might be an effective treatment for cancer-related nerve pain?

Research has shown that green tea extract (GTE) might help reduce nerve pain in cancer patients. One study found that GTE improved pain symptoms after eight weeks. Another small study suggested it could help with nerve pain caused by cancer treatments. In this trial, participants will receive either GTE or a placebo to evaluate its effectiveness. Although more research is needed, these early results are promising for using GTE as a natural way to ease nerve pain.14678

Who Is on the Research Team?

MD

Michael Daniel, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults who are cancer survivors experiencing nerve pain (neuropathic pain) related to their cancer or its treatment, and who are receiving supportive palliative care. People with certain medical conditions or on conflicting medications may not be eligible.

Inclusion Criteria

No known allergy to rice or rice flour (basis of placebo)
I have nerve pain caused by my cancer.
I have a DN4 neuropathic pain score of 4 or higher.
See 2 more

Exclusion Criteria

Self-describe as consuming more than 3 cups of green tea or matcha beverages on a daily basis
High probability of completing the study and all study-related measures/activities required by the protocol
I am currently receiving treatment for cancer.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily, oral, encapsulated green tea extract (GTE) or placebo to mitigate neuropathic pain

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Green Tea Leaf Extract Decaffeinated

Trial Overview

The study tests whether taking a daily capsule of decaffeinated green tea extract can help reduce nerve pain in cancer survivors compared to a placebo (inactive pill). Participants are randomly assigned to either the green tea extract or placebo group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Green Tea ExtractExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

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