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

  • STATUS
    Recruiting
  • End date
    Jan 29, 2024
  • participants needed
    120
  • sponsor
    University of Southern California
Updated on 25 November 2021
cancer
cyclophosphamide
absolute neutrophil count
breast cancer
doxorubicin
neutrophil count
docetaxel
adenocarcinoma
immunostimulant
prostate adenocarcinoma

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

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.

Details
Condition cancer, breast, Recurrent Prostate Cancer, Breast Cancer, Hormone-resistant Prostate Cancer, Breast Cancer Diagnosis, breast carcinoma
Treatment laboratory biomarker analysis, Dietary intervention, nutritional support, nutritional support
Clinical Study IdentifierNCT01802346
SponsorUniversity of Southern California
Last Modified on25 November 2021

Eligibility

Yes No Not Sure

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note