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NON-SMALL CELL LUNG CANCERPhase 3NCT01046383

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

A Phase 3 study testing IMN1207 and Casein in people with NON-SMALL CELL LUNG CANCER, run by Immunotec Inc. at 5 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NON-SMALL CELL LUNG CANCER
What is being tested?
IMN1207 and Casein
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
5 sitesCanada
Study dates
Jun 2010to Jun 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • CHUM - Hopital Notre Dame

    Montreal, Quebec, H2L 4M1

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 1L3

Other trials in Canada

About this study

Official title: Effect of IMN1207 Versus Casein on, Weight Loss, Survival and Quality of Life in Non-small Cell Lung Cancer Patients During or Following Chemotherapy, Radiation or Surgery: A Multi-center Randomized, Double-blind Study - Phase III Trial

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.

Read the detailed description

This new IMN 1207 study is a follow-up study to the first IMN 1207 trial which was sponsored by Immunotec Inc during the last 3 years. The study revealed that the cysteine-rich whey protein isolate formulation IMN 1207 caused a significant reversal of weight loss (P <0.05) and a conspicuous increase in survival. The outcome of the first IMN 1207 study has been published in (Tozer RG, et al. Cysteine-Rich Protein Reverses Weight Loss in Lung Cancer Patients Receiving Chemotherapy or Radiotherapy. Antioxid Redox Signal. 2008 Feb; 10(2):395-402). PMID:18158761.

The purpose 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 subjects with or without conventional therapy, i.e., chemotherapy or radiation. In addition, it is prospectively designed to test the hypothesis that, IMN1207 versus casein over a period of 66 weeks observation period which includes a 6 months follow-up period, increases the survival of these subjects. Also, the effect of IMN1207 on the quality of life in a defined subgroup of subjects will be determined.

Being tested
IMN1207, Casein
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
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Weight Loss, Cachexia, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMN1207Dietary supplement

    20 grams of IMN1207 per day for 40 weeks.

  • CaseinDietary supplement

    20 grams of Casein per day for 40 weeks

Study groups in NCT01046383
Study groupRoleWhat they receive
IMN1207ExperimentalDietary 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.
Receives: Dietary Supplement: IMN1207
CaseinPlacebo comparatorDietary 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.
Receives: Dietary Supplement: Casein

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 40 weeks

Secondary outcomes (8)

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

    Measured: 66 weeks

  2. The change in hand grip force.

    Measured: 40 weeks

  3. The change in Karnofsky performance status

    Measured: 40 weeks

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

    Measured: 40 weeks

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

    Measured: 40 weeks

  6. The change in the plasma concentration of C-reactive protein (CRP).

    Measured: 40 weeks

  7. The change in lymphocyte counts.

    Measured: 40 weeks

  8. The change in the dose of chemotherapy (percent) or discontinuation of chemotherapy or interruption of radiation in response to patients' cachexia.

    Measured: 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionJun 2012
  4. Study completionJun 2013

Why it stopped: Slower than anticipated recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01046383
Sponsor's protocol ID
IMN1207-07
Status last verified
Jun 2011
First submitted
8 Jan 2010
Last updated
21 Jan 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IMN1207 and Casein in people with NON-SMALL CELL LUNG CANCER, run by Immunotec Inc. at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slower than anticipated recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 40 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01046383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.

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