Trial Outcomes & Findings for Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer (NCT NCT00769652)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

3 years

Results posted on

2023-10-03

Participant Flow

Eight subjects were enrolled from October 2006 through May 2007 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center.

1 subject was consented but did not get randomized.

Participant milestones

Participant milestones
Measure	Medical Nutrition Therapy 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 Care : Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during \& after treatment".
Overall Study STARTED	6	1
Overall Study COMPLETED	6	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medical Nutrition Therapy n=6 Participants 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 n=1 Participants Standard care Standard Care : Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during \& after treatment".	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	61 years STANDARD_DEVIATION 4.9 • n=5 Participants	60 years n=7 Participants	60.9 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	1 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 years

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 years

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

Outcome measures

Outcome data not reported

Adverse Events

Medical Nutrition Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elizabeth Poplin, MD (sub-investigator)

Rutgers Cancer Institute of New Jersey

Phone: 732-235-8675

Email: [email protected]; [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place