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Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer

Primary Purpose

Breast Cancer, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

dietary intervention

nutritional support

laboratory biomarker analysis

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed breast cancer for which chemotherapy with AC (doxorubicin plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting OR metastatic 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)

Sites / Locations

USC Norris Comprehensive Cancer CenterRecruiting
USC Norris Oncology/Hematology-Newport BeachRecruiting
Mayo Clinic RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (low-calorie diet)

Arm II (normal diet)

Arm Description

Patients eat a special low-calorie diet during 3 days prior to chemotherapy, during the 12 weeks of chemotherapy, and 2 days 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 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.

Outcomes

Primary Outcome Measures

Rate of chemotherapy-related toxicity

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.

Secondary Outcome Measures

Tumor response

Measured using a summary statistic which includes Response Evaluation Criteria In Solid Tumors (RECIST) response, PSA response for men without measurable disease, pathologic complete response and clinical response for breast cancer patients. This rate will be compared between patients on the restricted diet and controls.

Full Information

NCT ID

NCT01802346

First Posted

February 27, 2013

Last Updated

November 18, 2022

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI), Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01802346

Brief Title

Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 29, 2013 (Actual)

Primary Completion Date

January 29, 2024 (Anticipated)

Study Completion Date

January 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI), Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This randomized phase II trial studies how well a controlled low calorie diet works in reducing side effects and increasing response to chemotherapy in patients with breast or prostate cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Eating a special diet with low calories may reduce the side effects of chemotherapy and improve the response to treatment

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I (low-calorie diet)

Arm Type

Experimental

Arm Description

Arm Title

Arm II (normal diet)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

dietary intervention

Other Intervention Name(s)

Dietary Modification, intervention, dietary

Intervention Description

Consume a low-calorie diet

Intervention Type

Procedure

Intervention Name(s)

nutritional support

Other Intervention Name(s)

nutritional assessment, nutritional care, support, nutritional

Intervention Description

Receive dietary advice

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Rate of chemotherapy-related toxicity

Description

Time Frame

Up to 12 weeks

Secondary Outcome Measure Information:

Title

Tumor response

Description

Time Frame

Up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed breast cancer for which chemotherapy with AC (doxorubicin plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting OR metastatic 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cheryl Kefauver, RN

Phone

323-865-0459

Cheryl.Kefauver@med.usc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Priya Jayachandran, MD

Organizational Affiliation

University of Southern California

Official's Role

Principal Investigator

Facility Information:

Facility Name

USC Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bartolo Santos, RN

Phone

323-409-4363

Bartolo.santos@med.usc.edu

First Name & Middle Initial & Last Name & Degree

Priya Jayachandran, MD

Facility Name

USC Norris Oncology/Hematology-Newport Beach

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristy Massopust

Kristy.Massopust@med.usc.edu

First Name & Middle Initial & Last Name & Degree

Diana Hanna, MD

Facility Name

Mayo Clinic Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trials Office

Phone

507-538-7623

12. IPD Sharing Statement

Learn more about this trial

Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer

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