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Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Primary Purpose

Breast Cancer, Colorectal Cancer, Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
memantine hydrochloride
placebo
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring cancer survivor, stage I non-small cell lung cancer, stage II non-small cell lung cancer, tobacco use disorder, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage I prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer, stage III prostate cancer, stage I colon cancer, stage IIA colon cancer, stage IIB colon cancer, stage IIC colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer, stage I rectal cancer, stage IIA rectal cancer, stage IIB rectal cancer, stage IIC rectal cancer, stage IIIA rectal cancer, stage IIIB rectal cancer, stage IIIC rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:

  • Survivors of non-metastatic breast, prostate, or colorectal cancer, or stage I/II non-small cell lung cancer
  • Age ≥ 18
  • Smoked 100 tobacco cigarettes over lifetime at time of first interview, have smoked 10 or more cigarettes per day on most days over the past month
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky ≥ 70%)
  • Ability to understand and the willingness to sign a written informed consent document
  • Agrees to adhere to the study protocol and attend the required clinic visits
  • Negative serum pregnancy test within 10 days prior to registration in women with child-bearing potential; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
  • Women who are currently breast-feeding are not eligible for this study

Exclusion Criteria:

  • Use of chewing tobacco, pipe tobacco, snuff, or any other non-cigarette tobacco product is not allowed
  • No patients with clinically significant uncontrolled medical conditions (e.g., unstable angina, myocardial infarction, transient ischemic attack [TIA], or cerebral vascular accident [CVA]) within past 3 months
  • Creatinine ≥ 2 times upper limit of normal (ULN) in last six months
  • Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate transaminase (SGPT) ≥ 3 times ULN in last six months
  • Current uncontrolled hypertension ≥ 160/90 mm Hg
  • Excessive alcohol abuse defined as more than 5 drinks per day for men and 4 drinks per day for women
  • Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up
  • History of allergic reactions attributed to memantine

PRIOR CONCURRENT THERAPY:

  • Six months post definitive treatment (except for ongoing hormonal or targeted therapies)
  • Patients currently must not be taking Nicotine Replacement Therapy (NRT) and agree to not start NRT for the duration of the study
  • Patients currently taking antidepressant or antianxiety medications must have been on a stable dose for 4 weeks prior to registration
  • Patients currently receiving the following medications are not eligible: anticonvulsant agents (e.g., phenytoin, carbamazepine, gabapentin, etc.); antiparkinsonian agents (e.g., Levo Dopa, ropinirole); neuroleptic agents (e.g., risperidone, quetiapine); carbonic anhydrase inhibitors (e.g., Diamox® and Sequels®)
  • Memantine should not be combined with other N-methyl d-aspartate (NMDA) antagonists (amantadine, ketamine, and dextromethorphan)
  • Participants may not be receiving any other investigational agents
  • No current use of illegal drugs or use of prescription medications for non-medical reasons

Sites / Locations

  • Wake Forest Cancer Center CCOP Research Base

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm I - Memantine

Arm II - Placebo

Arm Description

Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.

Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.

Outcomes

Primary Outcome Measures

Retention
Retention is defined as the percentage of participants who complete the 12 week visit
Adherence
Adherence is the percentage of prescribed pills taken while on therapy.

Secondary Outcome Measures

Nicotine Dependence
The Fagerstrom tolerance scale consists of 8 questions, each of which is scored on a 0 to 1 or 0 to 2 scale. The total score ranges from 0 to 11, with higher scores representing greater dependence.
Smoking Withdrawal
The Wisconsin Smoking Withdrawal Scale is a 28 item questionnaire that assesses nicotine withdrawal. It consists of seven subscales, each consisting of 3-5 questions all answered on a 0-4 scale. Subscale scores are the mean of the items comprising the scale. Some items are reverse scored. Higher scores indicate greater withdrawal symptoms. Subscales were scored if more than half the items were answered. A total score was calculated as the mean of the individual subscales (if more than half the subscales had scores).

Full Information

First Posted
February 14, 2012
Last Updated
September 7, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01535040
Brief Title
Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
Official Title
Randomized Placebo-Controlled Phase 2 Pilot Study of Memantine (Namenda) for Smoking Cessation Among Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2012 (Actual)
Primary Completion Date
February 1, 2014 (Actual)
Study Completion Date
February 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Memantine hydrochloride may help people stop smoking by decreasing the symptoms of nicotine withdrawal. PURPOSE: This randomized, pilot phase II trial studies how effective memantine hydrochloride works compared to placebo in helping cancer survivors stop smoking.
Detailed Description
OBJECTIVES: Primary Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (memantine hydrochloride) (10 mg twice daily) or a matching placebo for 12 weeks. Estimate the self-reported abstinence rates of patients who are randomized to memantine or a matching placebo for 12 weeks and obtain a preliminary estimate of the treatment effect (difference in abstinence rates between the two groups). Secondary Nicotine addiction will be assessed using the Wisconsin Inventory of Smoking Dependent Motives. Nicotine withdrawal will be measured by the Wisconsin Smoking Withdrawal Scale. Quality of life will be measured by the SF12 questionnaire. Toxicities will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4. OUTLINE: This is a randomized, placebo-controlled, pilot study. Participants are stratified according to gender (male vs female). Participants are randomized to 1 of 2 treatment arms. Arm I: Participants receive memantine hydrochloride orally (PO) twice daily (BID) on days 1-81 in the absence of unacceptable toxicity. Arm II: Participants receive placebo PO BID on days 1-81 in the absence of unacceptable toxicity. Participants complete the Behavioral Risk Factor Surveillance Survey (BRFSS), the Self-reported Tobacco Abstinence, the Wisconsin Inventory of Smoking Dependent Motives, the Wisconsin Smoking Withdrawal Scale, SF-12 quality-of-life questionnaire, and the Fagerstrom Nicotine Tolerance Scale at baseline and every 2 weeks for 12 weeks during study. Participants also undergo urine sample collection at weeks 4, 8, and 12 for cotinine test using the NicAlert test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer, Tobacco Use Disorder
Keywords
cancer survivor, stage I non-small cell lung cancer, stage II non-small cell lung cancer, tobacco use disorder, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage I prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer, stage III prostate cancer, stage I colon cancer, stage IIA colon cancer, stage IIB colon cancer, stage IIC colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer, stage I rectal cancer, stage IIA rectal cancer, stage IIB rectal cancer, stage IIC rectal cancer, stage IIIA rectal cancer, stage IIIB rectal cancer, stage IIIC rectal cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I - Memantine
Arm Type
Active Comparator
Arm Description
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
Arm Title
Arm II - Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
memantine hydrochloride
Other Intervention Name(s)
Memantine
Intervention Description
Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo by mouth through completion of 12 weeks.
Primary Outcome Measure Information:
Title
Retention
Description
Retention is defined as the percentage of participants who complete the 12 week visit
Time Frame
12 weeks
Title
Adherence
Description
Adherence is the percentage of prescribed pills taken while on therapy.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Nicotine Dependence
Description
The Fagerstrom tolerance scale consists of 8 questions, each of which is scored on a 0 to 1 or 0 to 2 scale. The total score ranges from 0 to 11, with higher scores representing greater dependence.
Time Frame
12 weeks
Title
Smoking Withdrawal
Description
The Wisconsin Smoking Withdrawal Scale is a 28 item questionnaire that assesses nicotine withdrawal. It consists of seven subscales, each consisting of 3-5 questions all answered on a 0-4 scale. Subscale scores are the mean of the items comprising the scale. Some items are reverse scored. Higher scores indicate greater withdrawal symptoms. Subscales were scored if more than half the items were answered. A total score was calculated as the mean of the individual subscales (if more than half the subscales had scores).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Survivors of non-metastatic breast, prostate, or colorectal cancer, or stage I/II non-small cell lung cancer Age ≥ 18 Smoked 100 tobacco cigarettes over lifetime at time of first interview, have smoked 10 or more cigarettes per day on most days over the past month Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky ≥ 70%) Ability to understand and the willingness to sign a written informed consent document Agrees to adhere to the study protocol and attend the required clinic visits Negative serum pregnancy test within 10 days prior to registration in women with child-bearing potential; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation Women who are currently breast-feeding are not eligible for this study Exclusion Criteria: Use of chewing tobacco, pipe tobacco, snuff, or any other non-cigarette tobacco product is not allowed No patients with clinically significant uncontrolled medical conditions (e.g., unstable angina, myocardial infarction, transient ischemic attack [TIA], or cerebral vascular accident [CVA]) within past 3 months Creatinine ≥ 2 times upper limit of normal (ULN) in last six months Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate transaminase (SGPT) ≥ 3 times ULN in last six months Current uncontrolled hypertension ≥ 160/90 mm Hg Excessive alcohol abuse defined as more than 5 drinks per day for men and 4 drinks per day for women Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up History of allergic reactions attributed to memantine PRIOR CONCURRENT THERAPY: Six months post definitive treatment (except for ongoing hormonal or targeted therapies) Patients currently must not be taking Nicotine Replacement Therapy (NRT) and agree to not start NRT for the duration of the study Patients currently taking antidepressant or antianxiety medications must have been on a stable dose for 4 weeks prior to registration Patients currently receiving the following medications are not eligible: anticonvulsant agents (e.g., phenytoin, carbamazepine, gabapentin, etc.); antiparkinsonian agents (e.g., Levo Dopa, ropinirole); neuroleptic agents (e.g., risperidone, quetiapine); carbonic anhydrase inhibitors (e.g., Diamox® and Sequels®) Memantine should not be combined with other N-methyl d-aspartate (NMDA) antagonists (amantadine, ketamine, and dextromethorphan) Participants may not be receiving any other investigational agents No current use of illegal drugs or use of prescription medications for non-medical reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Spangler, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Cancer Center CCOP Research Base
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

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