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

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00769652
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 8
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Malnutrition; Pancreatic Cancer; Prostate Cancer; Weight Changes	Behavioral: Medical nutrition therapy; Behavioral: Standard Care	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: 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
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Medical nutrition therapy Medical nutrition therapy	Behavioral: Medical nutrition therapy; Medical nutrition therapy (MNT) refers to 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.
Active Comparator: Standard care Standard care	Behavioral: Standard Care; Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".

Outcome Measures

Primary Outcome Measures

1. Change in Fat Free Mass (FFM) [3 years]

2. Change in Weight [3 years]

3. Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903

Sponsors and Collaborators

• Rutgers, The State University of New Jersey
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Maureen Huhmann, DCN, RD, CSO, Rutgers Cancer Institute of New Jersey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT00769652
• Other Study ID Numbers: CDR0000592862; P30CA072720; 000605; 0220060217
• First Posted: Oct 9, 2008
• Last Update Posted: Jan 7, 2014
• Last Verified: Nov 1, 2013

• Keywords provided by Rutgers, The State University of New Jersey: malnutrition; non-small cell lung cancer; small cell lung cancer; stage III prostate cancer; stage IV prostate cancer; pancreatic cancer; weight changes
• Additional relevant MeSH terms: Lung Neoplasms; Prostatic Neoplasms; Pancreatic Neoplasms; Malnutrition; Body Weight Changes

Study Results

Participant Flow

Recruitment Details	Eight subjects were enrolled from October 2006 through May 2007 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center.
Pre-assignment Detail	1 subject was consented but did not get randomized.

Arm/Group Title	Medical Nutrition Therapy	Standard Care
Arm/Group Description	Medical nutrition therapy Medical nutrition therapy : Medical nutrition therapy (MNT) refers to 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.	Standard care Standard Care : Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".
Period Title: Overall Study
STARTED	6	1
COMPLETED	6	1
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Medical Nutrition Therapy	Standard Care	Total
Arm/Group Description	Medical nutrition therapy Medical nutrition therapy : Medical nutrition therapy (MNT) refers to 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.	Standard care Standard Care : Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".	Total of all reporting groups
Overall Participants	6	1	7
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 66.7%	1 100%	5 71.4%
>=65 years	2 33.3%	0 0%	2 28.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61 (4.9)	60	60.9 (4.5)
Sex: Female, Male (Count of Participants)
Female	1 16.7%	0 0%	1 14.3%
Male	5 83.3%	1 100%	6 85.7%
Region of Enrollment (participants) [Number]
United States	6 100%	1 100%	7 100%

Outcome Measures

1. Primary Outcome

Title	Change in Fat Free Mass (FFM)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.

Arm/Group Title	Medical Nutrition Therapy	Standard Care
Arm/Group Description	Medical nutrition therapy Medical nutrition therapy : Medical nutrition therapy (MNT) refers to 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.	Standard care Standard Care : Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".
Measure Participants	0	0

2. Primary Outcome

Title	Change in Weight
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.

Arm/Group Title	Medical Nutrition Therapy	Standard Care
Arm/Group Description	Medical nutrition therapy Medical nutrition therapy : Medical nutrition therapy (MNT) refers to 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.	Standard care Standard Care : Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".
Measure Participants	0	0

3. Primary Outcome

Title	Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.

Arm/Group Title	Medical Nutrition Therapy	Standard Care
Arm/Group Description	Medical nutrition therapy Medical nutrition therapy : Medical nutrition therapy (MNT) refers to 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.	Standard care Standard Care : Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".
Measure Participants	0	0

Adverse Events

Time Frame	1 year
Arm/Group Title	Medical Nutrition Therapy		Standard Care
Arm/Group Description	Medical nutrition therapy Medical nutrition therapy : Medical nutrition therapy (MNT) refers to 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.		Standard care Standard Care : Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".
All Cause Mortality
	Medical Nutrition Therapy		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Medical Nutrition Therapy		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Medical Nutrition Therapy		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.