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."