Protocol: SWOG – S1912CD

SCHEMA SWOG 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 Alliance 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 – A191901

SCHEMA Alliance A191901

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. Women with an initial pathologically confirmed diagnosis of stage I-III, hormone receptor positive, HER2-neu negative, invasive breast cancer within 18 months prior to enrollment. Women who have undergone neo-adjuvant chemotherapy who have no residual invasive disease post-surgery are eligible based on an initial pathologically confirmed diagnosis. Hormone receptor positive is defined as estrogen receptor (ER) and/or progesterone receptor (PR) of >1%.  HER2-neu negative is defined as 0-1+ by ImmunoHistoChemical (IHC) analysis, or nonamplified by Fluorescence in situ Hybridization (FISH) analysis.
2. Patients must not have received cancer directed surgery, and/or completed all other adjuvant therapy, except reconstruction.
3. Patients must have initiated an endocrine therapy drug within the 6 months prior to registration, or have received a prescription with stated intent to initiate within 6 weeks after registration.
4. No history of previous cancers, invasive or non-invasive breast cancer at any time and non-breast cancer within the past 5 years, excluding non-melanoma skin cancer.
5. Patients must be willing to use a smart phone, but is not deemed ineligible if they do not have a smart phone.  If the patient does not own a smart phone or has limited data or texting capabilities or their smart phone cannot support the study app, a smart phone and service can be provided at no cost to the patient.
6. Patient must be 18 years of age.

Protocol: Alliance – A222004

SCHEMA Alliance 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 Wake Forest 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 Alliance 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 SWOG 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.