Please select the eligibility criteria that correspond to the clinical trial below.
Title: Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study
Brief Summary: Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is important for the generation of ATP, supply of anabolic substrates and defense against reactive oxygen species in tumor cells. In preclinical models, restricting glucose availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor growth.

Therefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic diet and transient fasting can enhance the efficacy of reirradiation in patients with recurrent glioblastoma.


Options:
A: Inclusion Criteria:

* Women
* Completed chemotherapy within past 2 years

  * completed for at least 3 months
* Self report cognitive dysfunction following chemotherapy
* Stage I-IIIA breast cancer
* Physically able to undertake moderate to vigorous physical activity program

Exclusion Criteria:

* Self report \> 90min/week of moderate physical activity (last 6 months)
* Mini-mental status exam score \< 23
* Co-morbid conditions that may alter cognitive testing results (i.e., a clinically diagnosed major depression, anxiety disorder, or other psychiatric condition, meeting DSM IV criteria)
* History of substance abuse
* Other neurological disorder (i.e., head injury, epilepsy, tumour, neurodegenerative disease)
* Ruled ineligible for MRI scanning (i.e., metal implants)
B: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed diagnosis of a solid tumor malignancy within the past 5 years

  * If the original histologic proof of malignancy is \> 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)
* Brain metastases must be visible on contrast-enhanced MRI or a contrast enhanced CT scan (for patients unable to undergo MRI within the past 28 days)

  * Patients unable to undergo MRI imaging because of non-compatible devices are eligible, provided the contrast-enhanced CT scans are obtained and are of sufficient quality
  * Patients who had undergone radiosurgery or surgical resection and are planning adjuvant whole-brain radiotherapy do not have to have visible disease but do need a baseline MRI
* Must have stable systemic disease (i.e. no evidence of systemic disease progression within the past 3 months)
* Patients with brain metastases at initial presentation are eligible and do not need to demonstrate 3 months of stable scans

PATIENT CHARACTERISTICS:

Inclusion

* Karnofsky performance status 70-100%
* Serum creatinine ≤ 3 mg/dL and creatinine clearance ≥ 30 mL/min
* Total bilirubin ≤ 2.5 mg/dL
* Blood urea nitrogen (BUN) \< 20 mg/dL
* Mini-mental status exam score ≥ 18
* Negative serum pregnancy test
* Fertile patients must practice adequate contraception

Exclusion

* Severe, active co-morbidity, defined as follows:

  * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  * Transmural myocardial infarction within the last 6 months
  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* Pregnant or lactating women
* Prior allergic reaction to memantine hydrochloride
* Current alcohol or drug abuse
* Intractable seizures while on adequate anticonvulsant therapy (i.e., more than one seizure per month for the past 2 months)

PRIOR CONCURRENT THERAPY:

Inclusion

* At least 14 days but no more than 56 days since prior therapy for brain metastasis, including radiosurgery and surgical resection
* No systemic chemotherapy for 14 days prior, during, or for 14 days after completion of whole-brain radiotherapy (WBRT)

Exclusion

* Prior cranial radiotherapy

  * Patients may have received up to 3 prior WBRT treatments and still be registered and randomized on the protocol provided WBRT parameters meet protocol requirements
* Chronic short-acting benzodiazepine use
C: Inclusion Criteria:

* age \>= 18 years
* recurrence of a histologically confirmed glioblastoma or gliosarcoma
* at least 6 months after first surgery
* at least 6 months after first radiotherapy
* interdisciplinary recommendation for reirradiation
* karnofsky performance status \>= 60, ECOG \<= 2
* creatinine \<= 2,0 mg/dl, urea \<= 100 mg/dl
* ALAT, ASAT \<= 7x upper normal limit

Exclusion Criteria:

* bowel obstruction, subileus
* insulin-dependent diabetes
* decompensated heart failure (NYHA \> 2)
* myocardial infarction within the last 6 months, symptomatic atrial fibrillation
* severe acute infection
* malnutrition, cachexia
* other medical conditions that might increase the risk of the dietary intervention
* pregnancy
* uncontrolled thyroid function
* pancreatic insufficiency
* dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study
D: Inclusion Criteria:

1)age 18 and older at time of registration. 2) recursive partitioning class (RPA) I or II. 3) 1 to 3 newly diagnosed brain metastases 4) must be eligible to have all lesions treated by SRS as determined by the radiation oncologist on the basis of location and size. 5)MRI with contrast must be performed with 1 month of registration. 6)Signed informed consent form approved by the IRB agreeing to randomization .

Exclusion Criteria:

1) prior WBRT 2) prior resection of brain metastasis, SRS or Gamma knife. 3) \> 3 brain metastases present on MRI 4) lymphoma, small cell lung cancer, leukemia, germ cell tumors. 5) leptomeningeal disease. 6) unknown primary.7) RPA Class III (i.e. KPS \< 70) 8) pregnancy.

Post-entry exclusion: No post-entry exclusions will be allowed after registration has occurred. All randomized patients will be included in the analysis and those lost to follow-up will be assigned the least favorable outcome (recurrence, death).

Answer: C