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Smoking Cessation Treatment for Head & Neck Cancer Patients

Q: How many participants are being admitted to this trial?

Unfortunately, the trial is no longer open for new participants. It was originally posted on March 24th 2010 and last updated on June 29th 2022. If you are seeking alternative studies to join, there are currently 621 medical trials searching for persons with head and neck cancers as well as 26 experiments involving Varenicline that seek volunteers.

Q: Have any other experiments been conducted to evaluate the efficacy of Varenicline?

Currently, 26 medical trials are in progress related to the drug Varenicline with 4 of those studies at Phase 3. Most are concentrated near Charleston, <a href="https://www.withpower.com/clinical-trials/south-carolina">South carolina</a> but there is a total 69 sites conducting clinical research on this medication.

Q: Are any positions still open for participation in this trial?

Unfortunately, no new patients can be accepted for this clinical trial. It initially appeared on the 24th of March 2010 and was last edited on 29th June 2022. However, if you are searching for more studies, 621 investigations recruiting <a href="https://www.withpower.com/clinical-trials/head-and-neck-cancer">head and neck cancer</a> sufferers actively exist alongside 26 trials using Varenicline which look to enrol participants.

Phase < 1

Waitlist Available

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Current or history of head and neck, lung, breast, gastrointestinal, or genitourinary cancer

Age 18 or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 6 weeks

Awards & highlights

Study Summary

This trial is designed to study and compare the effectiveness of two types of counseling for cancer patients who want to quit smoking: Acceptance and Commitment Therapy (ACT) and Motivational and Behavioral Counseling (MBC).

Who is the study for?

This trial is for English-speaking adults over 18 with a current or past diagnosis of head and neck, lung, breast, gastrointestinal, or genitourinary cancer who smoke. They must be recommended for varenicline treatment and able to consent to study procedures. Exclusions include planned long hospital stays, certain surgeries, use of specific smoking cessation drugs or treatments, severe depression or psychiatric risk factors.Check my eligibility

What is being tested?

The study compares two types of counseling: Acceptance and Commitment Therapy (investigational) versus Motivational and Behavioral Counseling (standard). It aims to determine which is more effective in helping patients quit smoking alongside their prescribed varenicline treatment.See study design

What are the potential side effects?

Potential side effects from the counseling sessions are minimal but may include emotional discomfort due to discussing personal issues related to smoking habits. Varenicline can cause nausea, sleep disturbances, mood changes, headaches, and increased appetite.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have or had cancer in my head, neck, lung, breast, stomach area, or reproductive organs.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Smoking Abstinence Rate

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280

50%

Dysgeusia

50%

Anxiety

36%

Sleep Disturbances

29%

Nausea

21%

Depression

21%

Agitation

21%

Headache

14%

Allergies

14%

Heartburn

14%

Cold

14%

Back Pain

Cellulitis

Sinusitis

Stomach Pain

Panic

Angina

Aggression

Palpitations

Rash

Confusion

Dizziness

Fatigue

Leg Spasms

Increased Blood Pressure

Malaise

Weight Gain

Gum Disease

Pharyngitis

Leg Cramps

Muscle Pain

100%

80%

60%

40%

20%

Study treatment Arm

Low Dose Varenicline

Standard Dose Varenicline

Trial Design

2Treatment groups

Experimental Treatment

Group I: MBC Group 2Experimental Treatment2 Interventions

Motivational and Behavioral Counseling (MBC). Varenicline 2 mg daily for 12 weeks.

Group II: ACT Group 1Experimental Treatment2 Interventions

Acceptance and Commitment Therapy (ACT). Varenicline 2 mg daily for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acceptance and Commitment Therapy

2010

Completed Phase 1

~1490

Varenicline

2011

Completed Phase 4

~4170

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,102 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,730 Total Patients Enrolled

Jan Blalock, PhDStudy ChairM.D. Anderson Cancer Center

1 Previous Clinical Trials

91 Total Patients Enrolled

Media Library

Acceptance and Commitment Therapy Clinical Trial Eligibility Overview. Trial Name: NCT01098955 — Phase < 1

Head and Neck Cancers Research Study Groups: ACT Group 1, MBC Group 2

Head and Neck Cancers Clinical Trial 2023: Acceptance and Commitment Therapy Highlights & Side Effects. Trial Name: NCT01098955 — Phase < 1

Acceptance and Commitment Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01098955 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being admitted to this trial?

"Unfortunately, the trial is no longer open for new participants. It was originally posted on March 24th 2010 and last updated on June 29th 2022. If you are seeking alternative studies to join, there are currently 621 medical trials searching for persons with head and neck cancers as well as 26 experiments involving Varenicline that seek volunteers."

Answered by AI

Have any other experiments been conducted to evaluate the efficacy of Varenicline?

"Currently, 26 medical trials are in progress related to the drug Varenicline with 4 of those studies at Phase 3. Most are concentrated near Charleston, South carolina but there is a total 69 sites conducting clinical research on this medication."

Answered by AI

Are any positions still open for participation in this trial?

"Unfortunately, no new patients can be accepted for this clinical trial. It initially appeared on the 24th of March 2010 and was last edited on 29th June 2022. However, if you are searching for more studies, 621 investigations recruiting head and neck cancer sufferers actively exist alongside 26 trials using Varenicline which look to enrol participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Smoking Cessation Treatment for Head & Neck Cancer Patients

2010. "Smoking Cessation Treatment for Head & Neck Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01098955.

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