Cachexia; CancerPhase 1NCT04131426
Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer Cachexia
A Phase 1 study testing Remune and EXCAP©® in people with Cachexia; Cancer and Weight Loss, run by University of Rochester at 1 site in United States.
Trial summary
The main purpose of this research study is to determine if the use of a nutritional supplement and exercise improve or worsen cachexia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia; Cancer, Weight Loss, Lung Cancer
- What is being tested?
- Remune and EXCAP©®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2020to 1 Apr 2022
- Phase
- Phase 1
- 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
- Be over the age of 18 years and have a primary diagnosis of colorectal, esophageal, gastric, pancreatic, biliary tract cancer (includes cholangiocarcinoma, gallbladder cancer, and ampullary cancer), or Non-small cell lung cancer (NSCLC) with plans to initiate systemic chemotherapy, targeted therapy or immunotherapy within the next 4 weeks after enrollment.
- Have been diagnosed as having an unresectable cancer with no plans for surgical intervention during the active study period (12 weeks).
- Have an ECOG performance score of 0 or 1.
- Have a life expectancy of >3 months as determined by their primary oncologist.
- Have experienced at least 2% weight loss of the patient's reported previous body weight over the 6 months prior to enrollment.
- Have permission from primary oncologist to engage in low to moderate intensity exercise regimen.
- Be able to read English (since the assessment materials are in printed format).
- Be able to give written informed consent.
Who cannot join
- Have any of the following limitations: unable to perform low-to-moderate intensity exercise regimen.
- Have had major surgery (excluding diagnostic procedures like laparoscopy, EGD/EUS, esophageal stent placement) in the past 4 weeks.
- Be experiencing dysphagia that requires enteral or parenteral feeding for nutrition.
- Be enrolled on hospice at time of consent.
- Be engaged in an active exercise routine by being identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form (67).
- Use of nutritional supplements containing EPA/DHA within 2 weeks prior to screening
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- Current Use of Vitamin D supplementation or St. John's wort that can influence efficacy and safety parameters. Chronic treatment (>12 weeks prior to screening) with multivitamin tablets is allowed (vitamin tablets must not contain more vitamin D than 150% of the recommended dietary allowance [RDA]).
- Known hypersensitivity or allergy to any of the study products. Specifically, patients allergic to milk, fish or shellfish will be excluded.
- Have AST/ALT >3x upper limit of normal (ULN) or >5xULN in those with liver metastases, Serum creatinine >2x ULN, Absolute Neutrophil Count <1,500/uL, Hemoglobin <9, Platelet count <75,000/uL at the time of baseline blood draw or any other Blood chemistry or hematology lab abnormalities that would exclude them from being able to receive standard chemotherapy or interventional clinical trial.
- Have uncontrolled Diabetes Mellitus as determined by primary oncologist or PI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effects of Dietary Supplementation With Remune on Cancer Associated Weight and Muscle Loss With and Without Exercise: A Randomized Pilot Feasibility Study.
The main purpose of this research study is to determine if the use of a nutritional supplement and exercise improve or worsen cachexia.
Read the detailed description
In this study the investigator would like to better understand how cachexia may improve or worsen, and how exercise and nutritional supplements may impact this process. The investigator would like to see whether a nutritional supplement (Remune) with or without a walking and progressive resistance exercise program (EXCAP©®, Exercise for Cancer Patients) can improve symptoms in patients with lung or gastrointestinal cancers with weight loss and cachexia. The investigator would also like to find out if this nutritional supplement and exercise intervention improves physical performance, day-to-day function, quality of life, and how the supplement and/or exercise may affect different markers in the blood over time.
- Conditions
- Cachexia; Cancer, Weight Loss, Lung Cancer, Gastrointestinal Cancer
- Being tested
- Remune, EXCAP©®
- Keywords
- Cachexia; Cancer, Weight Loss, Exercise, Nutritional Supplement, Lung Cancer, Gastrointestinal Cancer
- Medical subject headings
- Cachexia, Neoplasms, Weight Loss, Lung Neoplasms, Gastrointestinal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemuneDrug
Remune is intended for the dietary management of disease related malnutrition especially in patients with precachexia or cachexia due to cancer or COPD
EXCAP©®Other
Also called Exercise for Cancer Patients
EXCAP©® is a home-based low-to-moderate intensity program that employs a tailored walking prescription and total body resistance exercises
| Study group | Role | What they receive |
|---|---|---|
| Remune dosed twice daily | Experimental | A nutritional supplement taken twice per day each day and standard care for your cancer as prescribed by your oncologist Receives: Drug: Remune |
| Remune dosed twice daily and daily exercise with EXCAP | Experimental | A nutritional supplement taken twice by day each day and a home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist Receives: Drug: Remune; Other: EXCAP©® |
| Usual Care | No intervention | Usual standard care as prescribed by your oncologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
measured by adverse event severity and quantity
Measured: 3 months
Adherance
Did 70% of subjects in the supplement arm consume 60% of supplement evening. Patients are asked to report the number of cartons of Remune consumed each day and how much they consumed
Measured: 3 months
Recruitment and Retention
Recruitment of 45 patients (15 per arm) and at least 10 evaluable patients in each arm for retention rate of 66%
Measured: 3 months
Secondary outcomes (4)
Proportion of subjects that improve physical function- Walking
6 minute walk test distance; Participants are given a short warm up and cool down walking protocol in the test walking area in the University. During the 6-minute walk, participants will be asked to wear a sensor that will measure movement ability. The sensor is secured by an ergonomic belt around the participant's waist and allows for free body movement and comfort. Participants walk for a total of 6 minutes and cover as much distance as they can during this time. Upon completion of the test, the total distance walked is used to measure physical performance.
Measured: 3 months
Proportion of subjects that improve physical function- Power
Power will be assessed by the Stair Climb Performance Test (SCPT) which is performed by having subjects safely ascend a flight of stairs (approximately 10 stairs total) as quick and as safely as possible with supervision. The subject can use the handrail as a safety precaution if deemed necessary by the patient, physician, coordinator, or exercise physiologist. Power is calculated by force (calculated by body mass and acceleration due to gravity) multiplied by the velocity (distance/time).
Measured: 3 months
Proportion of subjects that improve physical function- Muscle Strength
Muscular strength will be assessed objectively using The Handgrip Dynamometer Test. The Handgrip Dynamometer Test is a grip strength test used to assess the maximal voluntary contraction generated by the arm muscles. The test is administered with the patient standing with the elbow joint angle held constant at 180 degrees and the medial distal humeral epicondyle held 2 inches from the torso. Trials will be performed in an alternating bilateral sequence, for a total of six attempts (three with each arm). The best score of the three hand-grip trials will be used for right and left limbs to calculate static strength.
Measured: 3 months
Porportion of subjects with improved cachexia-related symptoms 3 months
The Functional Assessment of Anoreix/Cachexia Therapy subscale is a 39-item questionnaire that measures general aspects of quality of life as well as specific anorexia/cachexia-related concerns. This will be collected at pre- and post intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start24 Apr 2020
- Primary completion13 Jan 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cachexia; CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Smartfish AS
- Responsible party
- Principal investigator, Richard Dunne, University of Rochester
- Investigators
- Richard Dunne, Principal investigator, University of Rochester Wilmot Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131426
- Sponsor's protocol ID
- UMLT19130
- Status last verified
- Aug 2023
- First submitted
- 11 Oct 2019
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Dietary Supplementation With Remune on Cancer Associated Weight and Muscle Loss With and Without Exercise: A Randomized Pilot Feasibility Study.
- ClinicalTrials.gov ID
- NCT04131426
- Acronym / sponsor ID
- UMLT19130
- Conditions
- Cachexia; Cancer, Weight Loss, Lung Cancer, Gastrointestinal Cancer
- Keywords
- Cachexia; Cancer, Weight Loss, Exercise, Nutritional Supplement, Lung Cancer, Gastrointestinal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Smartfish AS
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this research study is to determine if the use of a nutritional supplement and exercise improve or worsen cachexia.
Detailed description
In this study the investigator would like to better understand how cachexia may improve or worsen, and how exercise and nutritional supplements may impact this process. The investigator would like to see whether a nutritional supplement (Remune) with or without a walking and progressive resistance exercise program (EXCAP©®, Exercise for Cancer Patients) can improve symptoms in patients with lung or gastrointestinal cancers with weight loss and cachexia. The investigator would also like to find out if this nutritional supplement and exercise intervention improves physical performance, day-to-day function, quality of life, and how the supplement and/or exercise may affect different markers in the blood over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remune dosed twice daily | Experimental | Drug: RemuneA nutritional supplement taken twice per day each day and standard care for your cancer as prescribed by your oncologist |
| Remune dosed twice daily and daily exercise with EXCAP | Experimental | Drug: Remune, Other: EXCAP©®A nutritional supplement taken twice by day each day and a home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist |
| Usual Care | No intervention | –Usual standard care as prescribed by your oncologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be over the age of 18 years and have a primary diagnosis of colorectal, esophageal, gastric, pancreatic, biliary tract cancer (includes cholangiocarcinoma, gallbladder cancer, and ampullary cancer), or Non-small cell lung cancer (NSCLC) with plans to initiate systemic chemotherapy, targeted therapy or immunotherapy within the next 4 weeks after enrollment.
- Have been diagnosed as having an unresectable cancer with no plans for surgical intervention during the active study period (12 weeks).
- Have an ECOG performance score of 0 or 1.
- Have a life expectancy of >3 months as determined by their primary oncologist.
- Have experienced at least 2% weight loss of the patient's reported previous body weight over the 6 months prior to enrollment.
Key exclusion criteria (10 listed)
- Have any of the following limitations: unable to perform low-to-moderate intensity exercise regimen.
- Have had major surgery (excluding diagnostic procedures like laparoscopy, EGD/EUS, esophageal stent placement) in the past 4 weeks.
- Be experiencing dysphagia that requires enteral or parenteral feeding for nutrition.
- Be enrolled on hospice at time of consent.
- Be engaged in an active exercise routine by being identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form (67).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemuneRemune is intended for the dietary management of disease related malnutrition especially in patients with precachexia or cachexia due to cancer or COPD | Drug | Remune dosed twice daily, Remune dosed twice daily and daily exercise with EXCAP |
| EXCAP©®Also: Exercise for Cancer PatientsEXCAP©® is a home-based low-to-moderate intensity program that employs a tailored walking prescription and total body resistance exercises | Other | Remune dosed twice daily and daily exercise with EXCAP |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 3 months
measured by adverse event severity and quantity
Adherance
Time frame: 3 months
Did 70% of subjects in the supplement arm consume 60% of supplement evening. Patients are asked to report the number of cartons of Remune consumed each day and how much they consumed
Recruitment and Retention
Time frame: 3 months
Recruitment of 45 patients (15 per arm) and at least 10 evaluable patients in each arm for retention rate of 66%
4 secondary outcomes
Proportion of subjects that improve physical function- Walking
Time frame: 3 months
Proportion of subjects that improve physical function- Power
Time frame: 3 months
Proportion of subjects that improve physical function- Muscle Strength
Time frame: 3 months
Porportion of subjects with improved cachexia-related symptoms 3 months
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Dunne principal investigator
University of Rochester Wilmot Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Remune and EXCAP©® in people with Cachexia; Cancer and Weight Loss, run by University of Rochester at 1 site in United States.
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 10 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: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2023.