Research & Trial Information

SCHEMA NRG-CC004

Protocol #: NRG -CC004

Cancer Type: Cancer Control Gynecology

Eligibility Criteria:

1. Diagnosis of breast or gynecologic cancer (DCIS, ovarian, endometrial, vulvar, cervical and vaginal)

2. Completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy)

3. Post menopausal as defined by at least ONE of the following:

4. Age ≥ 18

5. History, Physical and Performance Status of 2 or less within 180 days prior to registration.

6. For breast cancer patients only, endocrine therapies are allowed (such as aromatase inhibitors, but tamoxifen is not allowed).

7. Vaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring (<7.5 mcg) and it has been used for at least 30 days with no plans to stop or alter use during the course of the study.

8. Antidepressants for mood and hot flashes, including SSRI’s will be allowed if patients have been on a stable dose for the last 60 days and the dose is not expected to change during the course of the study. Only subthreshold or low dose antidepressants will be allowed (i.e. Effexor 37.5 -75 mg or Lexapro 5-10 mg or Celexa 10 – 20 mg).

9. Women who report that their motivation/desire for sexual intimacy has decreased since her cancer diagnosis.

10. Able to swallow whole capsules.

Research & Trial Information

SCHEMA WF 97116

Protocol #: Wake Forest – WF97116

Cancer Type: Cancer Control Breast

Inclusion Criteria:

1. Women ≥18 years old with history of invasive breast cancer
2. Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to enrollment (Ongoing herceptin or other chronic HER 2 directed therapies are allowed).
3. Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study enrollment and plan to continue for the duration of the study (9 months).
4. Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted (patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet) if dose is stable over previous 12 weeks.
5. Self-reported cognitive problem plus a measured memory deficit (score <7 on single trial of Eligibility Pre-screen HVLT-R Form C).
6. ECOG performance status 0-2
7. Must be able to speak English

Exclusion Criteria:

1. Evidence or suspected recurrent or metastatic disease. Prior brain irradiation is not allowed.
2. Patients may not currently be taking Quinidine, Certinib, Highest Risk QTc-Prolonging Agents, MiFEPRIStone, or Succinylcholine.
3. History of dementia, Alzheimer’s disease, multi-infarct dementia or CVA (history of transient ischemic attack (TIA is allowed)
4. Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drugs are not allowed. For patients who have used these medications they must not have used them within 4 weeks prior to enrollment.
5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to donepezil. Hypersensitivity to donepezil.
6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia.
7. Traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia.
8. Psychiatric illness/social situations that would limit compliance with study requirements including but not limited to a history of schizophrenia, psychosis or substance abuse.
9. Untreated current severe depression. Currently treated depression is permitted if treatment is stable.
10. Patients with bradycardia, seizure disorder or peptic ulcer disease (PUD)

Research & Trial Information

SCHEMA MPR-1

Protocol#: NSABP – MPR-1 Registry

Cancer Type: Cancer Control/Prevention

Eligibility:

Research & Trial Information

SCHEMA GOG 0225

Protocol#: GOG – 0225

Cancer Type: Cancer Control/Prevention

Research & Trial Information

SCHEMA S1417CD

Protocol#: SWOG – S1417CD

Cancer Type: Cancer Control/Prevention 

ELIGIBILITY CRITERIA

When calculating time frame for date of diagnosis, the date that the pathological diagnosis was made is considered Day 0. If Day 30 or 120 falls on a weekend or holiday, the limit may be extended to the next working day.

1. Patients must have newly diagnosed metastatic colon or rectal cancer (mCRC) (de novo metastatic diagnosis) or metastatic recurrence after prior treatment for Stage I-III disease and be ≤ 120 days after diagnosis at time of registration.
2. Systemic chemotherapy and/or systemic biologic therapy must be planned to be administered ≤ 30 days after registration OR must have been initiated ≤ 60 days prior to registration. Patients who are planning palliative or hospice care only (no chemotherapy or biologic therapy) are not eligible.
3. Patients must be at least 18 years of age.
4. Patients must plan to receive treatment at the registering site. Registering site must be an NCORP site.
5. Patients must be able to complete questionnaires in English.
6. Patients must provide their full name, primary address in the U.S., birth date and social security number at registration for the purposes of accessing credit report data.

Research & Trial Information

SCHEMA S0820

Protocol#: SWOG – S0820

Cancer Type: Cancer Control/Prevention

Eligibility:

Research & Trial Information

SCHEMA GAP URCC 13059

Protocol#: URCC – 13059  GAP 70+

Cancer Type: Cancer Control/Prevention

Eligibility:

Research & Trial Information

Schema A011104

Protocol#: Alliance – A011104

Cancer Type:  Cancer Control Breast

Eligibility Criteria