Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
Breast Cancer, Colorectal Cancer, Lung Cancer
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
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
Active Comparator
Placebo Comparator
Arm I - Memantine
Arm II - Placebo
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.