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A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy


Phase 2
19 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer

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Trial Information

A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy


PRIMARY OBJECTIVES:

I. To obtain preliminary estimates of the impact of a restricted diet on toxicity and
efficacy of chemotherapy for breast and prostate cancer.

II. To evaluate the compliance with a controlled diet intervention.

III. To investigate changes in plasma insulin, glucose, insulin-like growth factor 1 (IGF1)
and IGF binding protein (IGFBP) levels in subjects who consume a restricted diet compared to
controls.

OUTLINE:

Patients are randomized to 1 or 2 treatment arms.

ARM I: Patients eat a special low-calorie diet during 3 days prior to chemotherapy, during
the 12 weeks of chemotherapy, and 24 hours after chemotherapy. Patients are provided with
all meals and all food to be consumed and maintain a diary of the food consumed and
appropriate amounts. Patients meet with the study dietician within 3 weeks of enrollment
and prior to, or on the day of, their first course of chemotherapy on study and at the start
of each subsequent course.

ARM II: Patients eat a normal diet and receive dietary advice which may include consultation
with a nutritionist. Patients maintain a diary of the food consumed and appropriate amounts.


Inclusion Criteria:



- Histologically confirmed breast cancer for which chemotherapy with AC (doxorubicin
plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting OR
castration-resistant prostate adenocarcinoma for which Docetaxel will be administered

- Body mass index (BMI) >= 18.5

- Subjects do not need to have measurable or evaluable disease; chemotherapy may be
administered in the neoadjuvant, adjuvant, or metastatic setting

- Prior therapy:

- Breast cancer subjects may not have received prior chemotherapy, with the
exception of curative-intent chemotherapy for a separate malignancy more than 3
years ago

- Prostate cancer subjects may have received prior treatment with metronomic
cyclophosphamide as this is considered anti-angiogenic/immunomodulatory and not
cytotoxic

- Prostate cancer subjects may be receiving a 2nd course of docetaxel provided
that ** The first course resulted in a PSA response (> 30% reduction in prostate
specific antigen [PSA] and/or improvement in radiographic findings or pain) and
the last dose was >= 9 months ago

- Prior Radiotherapy is allowed, provided at least 2 weeks have elapsed from completion
of radiotherapy to initiation of protocol treatment

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2x upper limit
of normal (ULN)

- Absolute neutrophil count (ANC) > 1500

- Platelets (plts) > 90,000

- Premenopausal women must have a negative pregnancy test and must agree to use barrier
contraception throughout the study period

Exclusion Criteria:

- Diabetes Mellitus

- Peripheral Neuropathy >= grade 1

- Prior therapy with inhibitors of IGF-1

- Concurrent use of somatostatin

- Significant food allergies which would make the subject unable to consume the food
provided (ex: shellfish, soy or egg allergy)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Rate of chemotherapy-related toxicity

Outcome Description:

Occurrence of Grade 2+ non-hematologic symptomatic toxicity (fatigue, nausea and vomiting, anorexia, neuropathy, mucositis, cystitis, stomatitis), evaluated according to Common Terminology Criteria for Adverse Events version 4.0. The two arms will be compared, in terms of the proportion of patients with the occurrence of one of these toxicities.

Outcome Time Frame:

Up to 12 weeks

Safety Issue:

Yes

Principal Investigator

Tanya Dorff

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

0S-10-3

NCT ID:

NCT01802346

Start Date:

January 2013

Completion Date:

January 2016

Related Keywords:

  • Breast Cancer
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Breast Neoplasms
  • Prostatic Neoplasms

Name

Location

USC Norris Comprehensive Cancer CenterLos Angeles, California  90089