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The Influence of Changes in Body Composition on Quality of Life in Cancer Patients and The Impact of Medical Nutrition Therapy by a Registered Dietitian on Outcome


N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Malnutrition, Pancreatic Cancer, Prostate Cancer, Weight Changes

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Trial Information

The Influence of Changes in Body Composition on Quality of Life in Cancer Patients and The Impact of Medical Nutrition Therapy by a Registered Dietitian on Outcome


OBJECTIVES:

Primary

- To describe the relationship between changes in body composition in cancer patients and
quality of life (QOL) as measured by Functional Assessment of Cancer Therapy-General
(FACT-G), Symptom Distress Scale, and ECOG performance status. (Part 1)

- To measure clinical (lean body mass, weight, Patient Generated Subjective Global
Assessment [PG-SGA] score) and patient outcomes (QOL FACT-G, Symptom Distress Scale,
and ECOG performance status) in weight-losing cancer patients undergoing chemotherapy
who have or have not received medical nutrition therapy (MNT). (Part 2)

Secondary

- To describe the percentage of lean body mass, weight, and QOL scores at time of
presentation for cancer treatment. (Part 1)

- To describe the percentage of lean body mass, weight, and QOL scores at subsequent time
points (3, 6, 12, 18, 24, 30, and 36 months) regardless of intervention. (Part 1)

- To determine percentage of lean body mass, weight, PG-SGA score, and QOL scores at time
of initial presentation for cancer treatment in patients presenting to a comprehensive
cancer center. (Part 2)

- Measure longitudinal changes in percentage of lean body mass, weight, PG-SGA score, and
QOL scores in cancer patients who have or have not received MNT. (Part 2)

OUTLINE: This is a two-part study.

- Part 1: Patients undergo observation. Patients may receive Medical Nutritional Therapy
(MNT) or standard care. Patients' health history and socio-demographic parameters,
weight, height, and body mass index (BMI), Patient Generated Subjective Global
Assessment (PG-SGA), bioelectrical impedance analysis (BIA), quality of life, and
survival data are measured at baseline and at 3, 6, 12, 24, and 36 months.

- Part 2: Patients are stratified according to tumor type (pancreatic vs lung vs
prostate). Patients are then randomized to 1 of 2 arms.

- Arm I (MNT session): Patients undergo one MNT session at baseline, weeks 2-3, and
weeks 6-9. Patients also meet with a registered dietitian (RD) in month 6.

- Arm II (standard care): Patients undergo standard care. Patients requiring
nutritional intervention are followed by the RD as requested by the patient or
healthcare team are taken off study. Patients undergo standard nutrition
counseling including a 24-hour dietary recall to measure compliance at each
treatment visit. Patients found to be non-compliant are counseled to promote
compliance.

In both arms, patients' weight, quality of life, and body composition are measured using the
Functional Assessment of Cancer Therapy-General (FACT-G), the Symptom Distress Scale (SDS),
ECOG performance status, BIA, and PG-SGA score.

All patients receive the National Cancer Institute's booklet "Eating Hints for Cancer
Patients: Before, During & After Treatment."

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Weight at 3, 6, 12, 18, 24, 30, and 36 months

Safety Issue:

No

Principal Investigator

Maureen Huhmann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

CDR0000592862

NCT ID:

NCT00769652

Start Date:

October 2006

Completion Date:

August 2009

Related Keywords:

  • Lung Cancer
  • Malnutrition
  • Pancreatic Cancer
  • Prostate Cancer
  • Weight Changes
  • malnutrition
  • non-small cell lung cancer
  • small cell lung cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • pancreatic cancer
  • weight changes
  • Body Weight Changes
  • Lung Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms
  • Malnutrition

Name

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903