Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer

Rutgers The State University of New Jersey

Status: Terminated

Conditions: Malnutrition; Lung Cancer; Weight Changes; Prostate Cancer; Pancreatic Cancer

Treatments: Behavioral: Standard Care; Behavioral: Medical nutrition therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00769652

CDR0000592862

P30CA072720 (U.S. NIH Grant/Contract)

0220060217 (Other Identifier)

000605 (Other Identifier)

Details and patient eligibility

About

This is a two-part study. Part I is an observational study. Part II is a randomized clinical trial to see how well medical nutrition therapy works compared with standard care in treating patients with lung cancer, pancreatic cancer, or stage III or stage IV prostate cancer.

Full description

In Part II of the study, patients are stratified according to tumor type (pancreatic vs lung vs prostate). Patients are then randomized to 1 of 2 arms.

• Arm I (Medical nutrition therapy): intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule.
• Arm II (standard care): Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".

In both arms, patients' weight, fat free mass, and Patient Generated Subjective Global Assessment Score (PG-SGA) score will be assessed before, during, and after the intervention. The PG-SGA includes a patient report of symptoms and a healthcare professional assessment of medical, metabolic, and physical parameters.

Enrollment: 8 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosed with one of the following:

  • Pancreatic cancer
  • Lung cancer
  • Stage III or IV prostate cancer

• Undergoing treatment at The Cancer Institute of New Jersey

  • Are undergoing chemotherapy (part 2 only)

• Has lost ≥ 5% of their usual body weight in the previous 6 months (part 2 only)

PATIENT CHARACTERISTICS:

• Life expectancy > 60 days
• Must speak and read English
• Accessible in person or by phone for completing questionnaires
• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Medical nutrition therapy

Experimental group

Description:

Medical nutrition therapy

Treatment:

Behavioral: Medical nutrition therapy

Standard care

Active Comparator group

Description:

Standard care

Treatment:

Behavioral: Standard Care