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Acupuncture for Lung Cancer (POISE Trial)

Phase 3

Recruiting

Led By Dugald Seely, ND, MSc

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults eligible for complete resection of lung, gastric or esophageal cancer

Be older than 18 years old

Must not have

Any wedge resections of lung cancer

Small cell, carcinoid, or gastrointestinal stromal (GIST) tumours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying the effect of acupuncture on quality of life for patients with thoracic cancer who are undergoing surgery.

Who is the study for?

This trial is for adults ready to undergo complete removal of lung, gastric, or esophageal cancer. It's not for those who've had minor lung surgery, seen a naturopathic doctor recently, are pregnant/breastfeeding, used experimental drugs lately, have certain tumor types or recent active cancer treatment.

What is being tested?

The trial tests an integrative approach combining nutrition and physical activity guidance with psychological support and supplements like Green Tea Extract and Vitamin D3. The goal is to improve quality of life after thoracic surgery by reducing complications and the risk of cancer returning.

What are the potential side effects?

Potential side effects from the supplements may include digestive issues, allergic reactions, changes in energy levels or mood disturbances. However, these interventions aim to be gentle and supportive alongside conventional care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung, stomach, or esophagus cancer can be completely removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a part of my lung removed due to cancer.

Select...

My cancer is not small cell, carcinoid, or GIST.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cross-over and contamination in the control arm - Mediterranean Diet Scores

Cross-over and contamination in the control arm - Physical Activity levels

Cross-over and contamination in the control arm - Psychological Health Activities

+3 more

Secondary study objectives

Communication

Inflammatory Response

Natural Killer Cell Function

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Integrative Care (Treatment)Experimental Treatment10 Interventions

Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation

Group II: Standard Care (Control)Active Control1 Intervention

Participants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Green Tea Extract

2019

N/A

~40

0 / 3Eligibility criteria met