Protocol: Alliance – A212102

Schema – A212102

Please Note: Below is partial eligibility, for full eligibility requirements, please contact the Genesys Hurley Cancer Institute, Research Department at (810)762-8181, (810)762-8079 and/or (810)762-8038. Thank you!

Eligibility:

Criteria for Participants with a Cancer Diagnosis

1. Histologically confirmed diagnosis of invasive cancer.
2. Stage I-IV.
3. One of the following tumor types: Head and Neck, Hepatobiliary, Lung, Lymphoma, Leukemia, Ovary*. Pancreas*, Multiple Myeloma, Gastric, esophageal or gastroesophageal, Breast, Thyroid, Kidney*, Endometrium, Prostate, Melanoma*, Sarcoma.
4. No prior definitive systemic or local anti-cancer intervention.
5. Age ≥ 40 and ≤ 75.
6. No known or prior history of in situ or invasive malignancy (excluding in situ nonmelanoma skin cancers) other than the current cancer diagnosis.
7. No history of organ transplantation.

Criteria for Participants with a High Suspicion of Cancer

1. High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw.
2. Age ≥ 40 and ≤ 75.
3. No known or prior history of in situ or invasive malignancy (excluding in situ nonmelanoma skin cancers).
4. No history of organ transplantation.
5. Ability to read and comprehend English or Spanish.

Protocol: WF-1901

Schema – WF-1901

Please Note: Below is partial eligibility, for full eligibility requirements, please contact the Genesys Hurley Cancer Institute, Research Department at (810)762-8181, (810)762-8079 and/or (810)762-8038. Thank you!

Eligibility:

1. Must have a documented diagnosis of invasive cancer that has been treated with either single modality therapy or any combination of surgery, radiation, and chemotherapy/drug therapy (e.g. cytotoxic therapy, targeted therapy, immunotherapy, hormonal therapy, etc.). Patients with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.

2. May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer that is felt to be stable and/or controlled and not rapidly progressive as per treating clinician judgement at the time of screening.

3. Patients who are actively receiving anticancer therapy at the time of screening should not have plans in place to change to another therapy for the duration of the delivered intervention period.

4. Patients who are actively receiving anticancer therapy at the time of screening must have been on that therapy for a minimum of four weeks prior to enrollment (i.e., no change in anticancer therapy in the previous month).

5. A minimum of four weeks must have elapsed since the completion of the most recent course of radiation therapy.

6. A minimum of four weeks must have elapsed since the most recent MAJOR surgical intervention.

7. A minimum of two weeks must have elapsed since the most recent MINOR surgical procedure (e.g., port placement).

8. Patients who are no longer receiving anticancer therapy must be ≤ 5 years since the completion of their anticancer therapy (e.g., time since the last day of chemotherapy administration, time since last day of radiotherapy, etc.).

9. Must have pain indicated by a score of ≥ 4 on PROMIS Pain Intensity (1a) scale, using the Pain Eligibility Interview within the Screening Interview.

10. Patients do not have to be on analgesic medications of any kind in order to participate. If they are taking analgesics, they must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14 days prior to enrollment. Eligible patients should not have planned upward dose titration of their analgesics during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluationtimepoint 2 (T2)). Patients may elect to decrease their analgesic use during the study as per discussions with their provider.

11. Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment.

12. Must be expected to be able to complete all study activities including the 22- and 34-week followup assessments according to the treating/referring clinician.

13. ECOG performance status of 0, 1, or 2.

14. Age ≥18 years at the time of study entry.

Ineligibility:

1. Has a disability that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive impairment, diagnosis or clinical evidence of severe psychiatric disorder, or diagnosed drug or alcohol abuse disorder), as per patient report or documented in the medical record.
2. Reports only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).
3. Has a known or suspected diagnosable substance use disorder or opioid overuse disorder (according to DSM-5 criteria), or is actively receiving treatment for a substance use disorder, as per patient report or documented in the medical record.
4. Currently being prescribed buprenorphine or suboxone.
5. Patients enrolled on hospice care or end-of-life palliative care are not eligible for enrollment. Patients whose local care network provides an opportunity for palliative (symptom management) or supportive care concurrent with active treatment following diagnosis (i.e. not solely as a palliative or end-of-life measure) are considered eligible for this study.
6. Does not have reliable access to Internet or sufficient personal data plan, and is not willing to participate in the Tablet Lending Program provided for this study.
7. Does not have a working email address.

Protocol: ECOG – EA8184

Schema – EA8184

Please Note: Below is partial eligibility, for full eligibility requirements, please contact Genesys Hurley Cancer Institute Research Department at (810) 762-8181, (810) 762-8079, and/or (810) 762-8038. Thank you!

Eligibility:

(Step 0: Screening):

1. Patient must be ≥ 21 years of age.

2. Patient must speak English or Spanish.

3. Patient must have biopsy-proven (consisting of ≥ 12 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core in the most recent biopsy using mpMRI-Prostate or TP Biopsy or TRUS Biopsy.

4. Patient must be on active surveillance.

5. Patient’s baseline biopsy must have occurred at least 6 months but not more than 18 months prior to preregistration to Step 0. NOTE: Patient is to be scheduled for a follow-up prostate biopsy 6
months after the initiation of treatment on this study.

6. Patient must have a serum PSA < 10 ng/mL or PSAD <0.15 ng/mL/ g obtained within 30 days of preregistration.

7. Patient must have an ECOG performance status 0−1.

8. Patient must be willing to abstain from consumption of any supplements containing green tea catechins.

9. Patient must be willing to restrict tea consumption to less than three (3) servings of hot tea or three (3) servings of iced tea per week (serving size of 8 oz).

10. Patient must be willing to discontinue current vitamin/mineral supplement use if it contains green tea products and use one provided by study.

11. Patient must be willing to take study agent or placebo at the dose specified with meals.

12. Patient must not have had prior treatment for prostate cancer, including focal therapy, with surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgendeprivation therapy.

13. Patient must not have prostate cancer with distant metastases.

14. Patient must not have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

(Step 1):

1. Patient must have Gleason Score (3+3) or predominant Gleason pattern 3 (3+4), ≤ 33% of biopsy cores, and ≤ 50% involvement of any biopsy core confirmed via central review.
2. Patient must have % Ki-67 Expression of 3% or more in at least 1 core positive for tumor confirmed via central review.

Protocol: SWOG – S1912CD

Schema – S1912CD

Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

1. Patients must have a diagnosis of a metastatic solid tumor or a hematologic malignancy and must receive anti-cancer treatment per the timing described in Section 5.2a (i.e. chemotherapy, hormonal therapy, targeted therapy, biologic therapy, immune therapy, bone marrow transplant). Patients with indolent hematologic diseases undergoing observation alone are not eligible.
2. Patients with recurrent solid tumors will be allowed as long as 1) this is the first presentation of metastatic disease and 2) the diagnosis of the metastasis is at least
   180 days (6 months) after the diagnosis date of the previous earlier stage cancer.
3. Patients with a history of secondary malignancy are allowed as long as they were not diagnosed within the previous 24 months, are not on active therapy, and are
   disease-free. Patients with adequately treated basal cell or squamous cell skin cancer, and in situ cervical cancer at any point prior to enrollment are eligible.
4. Patients who have started anti-cancer treatment for the current diagnosis must have started within 60 days prior to registration.
5. Patients who are planning to start anti-cancer treatment for the current diagnosis must start within (≤) 30 days after registration.
6. Patients may not be enrolled in hospice care at the time of registration.
7. Patients must be at least 18 years of age.
8. Patients must have a Zubrod performance status of 0-2.
9. 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. (This may be obtained directly from the patient, study questionnaires, or the medical record.)
10. Spouse caregivers must be willing to participate in the trial.
11. Spouse caregivers must be legally married, or file their tax returns as married filing jointly.*
12. Spouse caregivers must be living in the same household with the eligible patient enrolling in this trial.

Protocol: Alliance – A222001

Schema – A222001

Please Note: Below is partial eligibility, please contact GHCI Research Department for full eligibility requirements at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

1. Men who are currently receiving androgen deprivation therapy for the treatment of prostate cancer.
2. Patients must be on a stable dose of all hormone directed therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration.  Patients receiving radiation therapy during the study period are eligible.
3. Patients must have bothersome hot flashes for greater to or equal to 14 days prior to registration, defined by an occurrence of greater to or equal to 28 times per week and of sufficient severity to cause the patient to seek therapeutic intervention.
4. No current or prior use of oxybutynin.
5. Must be 18 years of age.
6. Patients with urinary retention requiring indwelling or intermittent self-catheterization within the prior 6 months are not eligible.
7. Life expectancy of greater than 6 months.
8. ECOG Performance Status 0-2

Protocol: Alliance – A222004

Schema – A222004

Please Note: Below is partial eligibility, for full eligibility requirements, please contact GHCI Research Department at (810)762-8181, (810)762-8079 and/or (810)762-8038. Thank you!

Eligibility:

1. Diagnosis of advanced cancer.
2. Patient report 2 month weight loss of at least 5 pounds (2.3 kilograms) and/or physician estimated caloric intake of less than 20 calories/kilogram of body weight per day.
3. The patient must perceive loss of appetite and/or weight as a problem, and have an appetite score of 4 or worse on the “Please rate your specific appetite” question that requires a patient response on a 0-10 numeric rating scale.
4. Not receiving ongoing tube feedings or parenteral nutrition at the time of registration.
5. Not currently using systemic adrenal steroids (with the exception of short term dexamethasone within 3 days of chemotherapy for control of chemotherapy side effects).
6. No use of androgens, progesterone analogs, or other appetite stimulants withint he past month.
7. No Covid-19 infection in the past hat, in the opinion of the treating physician, had left patients with compromised taste, which has not resolved at the time of registration.
8. At least 18 years of age.
9. Estimated life expectancy of 3 months or longer.
10. No treatment with another antipsychotic agent, such as risperidone, quetiapine, clozapine, butyrophenone within 30 days of enrollment.

Protocol: Wake Forest WF-1806

Schema – WF-1806

Please Note: Below is partial eligibility, for full eligibility requirements, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

1. Older adults (age ≥ 60y) with either: 1. Newly diagnosed metastatic CRC or 2. Newly recognized metastatic recurrence or CRC greater than 1 year from completion of treatment for non-metastatic CRC.
2. Planning to undergo immunotherapy and/or 5/FU based chemotherapy as first line of treatment.  5-FU chemotherapy can be 5-FU alone or in combination with oxaliplatin and/or irinotecan; +/- immunmotherapy. Capecitabine is also acceptable.
3. Life expectancy greater than or equal to 6 months.
4. Patient eligibility is not dependent on BMI or weight.  Patients with a significant (+- > 10%) body weight change in the previous 12 months are eligible for this study.

Ineligibility:

1. Patients enrolled in hospice.
2. Prior systemic chemotherapy for metastatic colorectal cancer (acceptable if adjuvant chemotherapy completed greater to or equal to 12 months prior disease recurrence).
3. Patients may not be receiving any other investigational agents.
4. No untreated brain metastases. Patients with treated brain metastases are eligible.
5. Patients on or planned to undergo radiation therapy in the near future.

Protocol: Alliance – A221805

Schema – A221805

Please Note: Below is partial eligibility, for full eligibility requirements, please contact GHCI Research Department at (810)762-8181, (810)762-8079 and or (810)762-8038. Thank you!

Eligibility:

1. Stage II-III colorectal cancer patients scheduled to receive treatment.
2. No prior neurotoxic chemotherapy.
3. No pre-existing clinical or pre-clinical peripheral neuropathy from any cause.
4. At least 25 years of age.
5. ECOG Performance Status 0-2

PROTOCOL: SWOG-S0820

Schema – S0820

Please Note: Below is partial eligibility, for full eligibility requirements, please contact GHCI research Department at (810)762-8181, (810)762-8079 and/or (810)762-8038. Thank you!

ELIGIBILITY:

1. Patients must have a history of Stage 0-III colon or rectal adenocarcinoma that has been treated per standard care with resection alone or in combination with radiation or chemotherapy. Adjuvant chemotherapy and RT treatment must have been completed at least 30 days prior to registration.
2. Patient with history of segmental resections are eligible (i.e. right colectomy, extended right colectomy, transverse colectomy, left colectomy, extended left colectomy, sigmoid colectomy, low anterior resection, abdominoperineal resection).  The definition of resection does not include endomucosal resection.  Patients that have received total proctocolectomy are ineligible. In addition to segmental resections, the following types of procedures are allowed:                        Polypectomy: For Tis (Stage 0) or pT1 patients only, resection may consist entirely of polypectomy (without completion of partial colectomy) if ALL of the following criteria are met: • Single specimen, completely removed. • Negative margins of resection • Grade 1 or 2 • No angiolymphatic invasion        Transanal local excision is allowed for pT1 rectal cancer patients with well or moderately differentiated tumors if NCCN criteria for transanal excision are met,
   as stipulated here:  NCCN Criteria for Transanal excision:    • <3 cm in size  • T1  • Grade 1 or 2  • No lymphatic or venous invasion • Negative margin  • Sm3 depth of tumor invasion is not allowed    When the lesion can be adequately identified in the rectum, transanal endoscopic microsurgery (TEM) may be used. TEM for more proximal lesions may be technically feasible.
3. Patients must be registered between 120 days and 456 days (inclusive) of primary resection. Patients must show no evidence of colorectal cancer based on post-operative colonoscopy (performed at least 120 days after the colon or rectal resection date and prior to registration). Patients with adenomas detected at the one-year post-operative colonoscopy are eligible if all adenomas have been completely removed.
4. Patients must be at least 18 years of age.
5. Patients must not have a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, inflammatory bowel disease, biallelic mismatch repair deficiency syndrome, or constitutional mismatch repair deficiency syndrome.
6. Patients must have a pure tone audiometry evaluation to document air conduction within 30 days prior to registration.  Note: No order for audiometry evaluation should be scheduled until the potential participant has met all other eligibility criteria required for this study.
7. Zubrod Performance Status 0-1.
8. Patients must not be expecting to receive radiation or additional chemotherapy.
9. Patients must not be receiving or plan to receive concomitant oral or intravenous corticosteroids on a regular basis, nonsteroidal anti-inflammatory drugs (NSAIDS), nor anticoagulants on a regular basis.
10. Patients must have the ability to swallow pills.
11. Patients with prior malignancy or concurrent malignancy that is currently not being treated, whose natural history or treatment (in the opinion of the physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

PROTOCOL: URCC-18007

Schema – URCC-18007

Please Note: Below partial eligibility, for full eligibility requirements, please contact GHCI Research Department at (810)762-8181, (810)762-8079 and/or (810)762-8038. Thank you!

ELIGIBILITY:

1. Be female at least 18 years of age.
2. Been diagnosed with Stage I-III breast cancer.
3. Be currently breast cancer-free.
4. Report moderate to severe fatigue in the past week.
5. Attribute their fatigue to cancer and/or its treatment.
6. Have completed surgery, radiation, standard dose chemotherapy, and/or targeted therapy 12-60 months previously (participants can be receiving hormonal therapy – i.e., tamoxifen, anastrozole, letrozole, exemestane).
7. No other medical condition in which fatigue is a prominent symptom as documented in the medical chart (e.g., anemia, autoimmune disease, sleep apnea).
8.  Not be currently taking Bupropion, Wellbutrin, Forfivo, Aplenzin, or Zyban (i.e., bupropion prescribed
   for other indications); an anti-depressant including but not limited to an MAOI inhibitor, antipsychotic, a systemic anti-TNF agent, linezolid, methylene blue, or a systemic corticosteroid (patients who have previously completed treatment with these agents at least one week prior and meet all other eligibility criteria are eligible to participate). Participants should be off an MAOI for at least 2 weeks prior to study entry.

PROTOCOL: URCC-16070

Schema – URCC-16070

Please Note: Below partial eligibility, for full eligibility requirements, please contact GHCI Research Department at (810)762-8181, (810)762-8079 and/or (810)762-8038. Thank you!

ELIGIBILITY:

1. Patients must have a diagnosis of breast cancer and be chemotherapy naive. Note: Prior methotrexate for non-cancerous conditions is allowed.
2. Be scheduled to receive a single day chemotherapy regimen that contains doxorubicin, and/or cyclophosphamide, and/or carboplatin. Herceptin (trastuzumab) and other chemotherapy agents will be allowed with any of these regimens.
3. Be scheduled to receive an antiemetic regimen that does not contain Akynzeo.  For chemotherapy regimens with a high emetic risk, the antiemetic regimen must include an NK-1 antagonist receptor, a 5HT3 receptor antagonist and dexamethasone. Other antiemetics, including additional dexamethasone and olanzapine, ma also be included at cycle one.  For chemotherapy regimens with a moderate emetic risk, the antiemetic regimen must include a 5HT3 receptro antagonist and dexamethasone. Other antiemetics, including additional dexamethasone and olanzapine, may also be included at cycle one.
4. Must be at least 18 years of age.
5. ECOG Performance Status 0-2.