Supportive Care

Key Eligibility Criteria:

Inclusion:
1. < 40 years of age at the time of enrollment
2. Patient must be a post-menarchal female and report that their initial menstrual period occurred > 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.)
3. Newly diagnosed with first cancer, exclusive of breast cancer.
4. Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard.
5. For patients < 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m^2 cumulative cyclophosphamide equivalent dose (CED). For patients ≥ 20 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators that contribute to CED.

Exclusion:
1. Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).
2. Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).
3. Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.
4. Prior receipt of systemic chemotherapy. However, steroids and intrathecal chemotherapy are permitted prior to study enrollment.
5. Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).

For pre-screening, please contact: Please reach out to the Disease specific research teams.

Key Eligibility Criteria:

Inclusion Criteria:
1. Planned intravenous treatment with a minimum of 12 weeks of neurotoxic chemotherapy treatment and with no planned treatment pause for surgery during neurotoxic chemotherapy treatment.
a. With one of the following treatments:
i. Chemotherapy regimens based on Oxaliplatin
1. FOLFOX every 2 weeks
2. FOLFIRINOX every 2 weeks
ii. Chemotherapy regimens based on single-agent Paclitaxel
1. Paclitaxel weekly
2. Paclitaxel every 3 weeks
iii. Chemotherapy regimens based on Paclitaxel + Carboplatin
1. Paclitaxel weekly with Carboplatin weekly/every 3 weeks
2. Paclitaxel every 3 weeks with Carboplatin every 3 weeks
b. Concurrent administration of the chemotherapies listed in the inclusion criteria with or without targeted agents/immunotherapy at standard doses is allowed (such as trastuzumab, pertuzumab, bevacizumab, pembrolizumab or other immune checkpoint inhibitors).
2. Planned taxane or platinum containing portion of chemotherapy regimen prescribed to last at least 12 weeks in duration and less than or equal to 12 months in duration. Note: The regimen is prescribed as per physician discretion in accordance with standard of care guidelines.

Exclusion Criteria:
1. Baseline peripheral neuropathy of any kind as defined by NCI CTCAE v5.0 grade > 0.
2. Any open wounds, sores, cysts or injury on the participant's hand or on part of the upper arm where the device will be applied or on the participant's feet or part of the lower leg where the device will be applied, which in the opinion of the investigator will not be healed prior to infusion commencing or who in the opinion of the investigator will be inappropriate for inclusion in this study.
3. Weight greater than 140 kg at the time of enrollment.
4. Participants who are receiving neuropathy directed systemic therapies at the time of enrollment, namely, Pregabalin, Gabapentin, Amitriptyline, Nortriptyline, Venlafaxine, Duloxetine.

For pre-screening, please contact: Reach out to the disease specific research team.

Key Eligibility Criteria:

Inclusion Criteria:
1. Must meet the following:
a) Newly diagnosed metastatic or unresectable locally advanced (i.e., surgery with curative intent is not an option) colorectal adenocarcinoma and about to start first line chemotherapy. Patients must not have relapsed within 6 months after completing prior treatment for early-stage disease.
b) Determined by the Investigator to be ready to receive their second dose of chemotherapy.
c) If currently participating in the clinical trial under the original protocol and the patient is willing to continue the study drug for a maximum total of 12-weeks of study drug treatment once Amendment #1 is IRB / IEC approved, the updated consent has been signed during the patient’s participation, and the patient is still receiving study drug treatment as part of the 28-day study.
2. Starting chemotherapy routines allowed are: FOLFOX, FOLFIRI, or FOLFIRINOX with or without bevacizumab, or other monoclonals or other FDA approved agents to be dosed every 2 weeks. The primary cancer therapy (dose, schedule, or drugs) may be changed as medically indicated.
3. Must have a BMI ≤ 33 kg/m2.
4. Must be able and willing to safely self-inject daily or be injected by a caregiver.
5. Able to eat and digest food normally. Patients with colostomies are allowed.

Exclusion Criteria:
1. Patients receiving second line or later systemic treatment .
2. History of weight loss surgery including gastric stapling, or bypass surgery.
3. Unintentional weight loss ≥ 10% of usual body weight in 4 months prior to Screening or other weight loss considered significant by the Investigator.
4. Currently using any new agent designed to increase appetite or otherwise affect weight (increase or decrease). Antiemetics to control nausea are acceptable.
5. History of bulimia or anorexia.

For internal pre-screening, please contact:
Epic message basket- Reach out to the disease specific research team.

Key Eligibility Criteria:
Inclusion Criteria:
1. Documented histologic or cytologic active diagnosis of mPDAC (locally advanced disease is not eligible)
2. Completed 1 × 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 × 14-day cycles of FOLFIRINOX chemotherapy and must be prior to receiving the next cycle of nab-paclitaxel plus gemcitabine chemotherapy or FOLFIRINOX chemotherapy
3. Cachexia as defined by Fearon criteria

Exclusion Criteria:
1. Current active reversible causes of decreased food intake, as determined by the investigator.
2. Receiving tube feedings or parenteral nutrition (either total or partial) at the time of screening or randomization.
3. Cachexia caused by reasons other than mPDAC

For internal pre-screening, please contact: Epic message basket- VICC RESEARCH GI