Effect of IMN1207 Versus Casein on Weight Loss, Survival and Quality of Life in Non-small Cell Lung Cancer Patients

NCT01046383 | Terminated Phase 3

• 1 other identifier: IMN1207-07
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 5

Brief Summary

The primary aim of this IMN 1207 follow-up study is to confirm the effect of a cysteine-rich non-denatured whey protein isolate formulation IMN1207 (20g daily) versus casein (20 g daily) on the reversal of weight loss (cancer-related wasting) over a 40 week treatment period in non-small cell lung cancer patients with or without conventional therapy, i.e., chemotherapy or radiation. And to test the hypothesis that over a period of 66 weeks observation period which includes a 6 months follow-up period, increases the survival of these patients.

Conditions

NON-SMALL CELL LUNG CANCER

Keywords

NON-SMALL CELL LUNG CANCER PATIENTS; WEIGHT LOSS; QUALITY OF LIFE; SURVIVAL; CHEMOTHERAPY; RADIOTHERAPY; SURGERY; CYSTEINE-RICH WHEY PROTEIN ISOLATE; IMN1207; CANCER-RELATED WASTING (CACHEXIA); BODY WEIGHT; NUTRITIONAL PROTEIN SUPPLEMENT

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study is the % change in body weight in the IMN1207 group compared to casein over a 40 weeks treatment period.

  40 weeks

Secondary Outcomes (8)

• The survival/mortality over a 66 weeks observation period which includes a 6 months follow-up period

  66 weeks

• The change in hand grip force.

  40 weeks

• The change in Karnofsky performance status

  40 weeks

• The assessment of the McGill QOL and the modified Edmonton Symptom Assessment Scale (ESAS).

  40 weeks

• The 'repeated standing up/sitting down' test from the Simmonds Physical Performance assessment battery.

  40 weeks

Study Arms (2)

IMN1207

EXPERIMENTAL

Dietary Supplement: IMN1207 Stratum A: CRP \<40 mg/L and WBC \< 11x109/L (i.e. subjects with relatively low levels of inflammation). Stratum B: CRP ≥ 40 mg/L and/or WBC ≥ 11x109/L (i.e. subjects with relatively high levels of inflammation.

Dietary Supplement: IMN1207

Casein

PLACEBO COMPARATOR

Dietary Supplement: Casein. Stratum A: CRP \<40 mg/L and WBC \< 11x109/L (i.e. subjects with relatively low levels of inflammation). Stratum B: CRP ≥ 40 mg/L and/or WBC ≥ 11x109/L (i.e. subjects with relatively high levels of inflammation.

Dietary Supplement: Casein

Interventions

IMN1207 DIETARY_SUPPLEMENT

20 grams of IMN1207 per day for 40 weeks.

IMN1207

Casein DIETARY_SUPPLEMENT

20 grams of Casein per day for 40 weeks

Casein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non small cell lung cancer stage III or stage IV.
• Karnofsky performance status greater or equal to 70%.
• Expected participation in study for more than 3 months.
• Involuntary decrease in body weight of more than 3% over the 1-5 months period immediately preceding study entry.
• Age 18 or older.
• Serum creatine less or equal to 3.0mg/dL or 265 µmol/L.
• Total bilirubin in the normal range (0.2-1.2 mg/dL) SGPT equal to or less than 4 times the upper limit of normal.
• Reliable contraception (ovariectomy, hysterectomy, tubuligation for at least six months, oral contraceptive, barrier method, etc.) for women of child bearing potential.

You may not qualify if:

• History of angioedema or allergic reactions to any compound employed in this study.
• Pregnancy and lactating.
• Uncontrolled metastatic brain tumors.
• Milk protein intolerance.
• Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements.
• Presence of ascitis or edema according to principle investigator's clinical judgment.
• Significant anemia, as defined by the requirement of treatment with EPO.
• Subjects with either mild or soy allergy/intolerance.

Sponsors & Collaborators

• Immunotec Inc.: lead

Study Sites (5)

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 1L3, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

CHUM - Hopital Notre Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Weight Loss; Cachexia; Body Weight

Interventions

Caseins

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Body Weight Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 12, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2013
• Last Updated: January 21, 2015

Record last verified: 2011-06

Locations

CA (5)