Lung CancerNCT02585362
Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program
A study testing physical exercise, nutrition counseling and whey protein supplement in people with Lung Cancer and Gastro-Intestinal Cancer, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
This study evaluates physical performance in cancer outpatients during a multimodal therapy. Half of the patients will receive physical exercise und nutrition program in combination with a specially formulated whey protein supplement, while the other half will receive standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Gastro-Intestinal Cancer, Breast Cancer
- What is being tested?
- physical exercise, nutrition counseling and whey protein supplement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2016to Oct 2018
- Phase
- Interventional
- 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
- Advanced cancer patients not eligible for curative treatment: lung cancer, gastrointestinal cancer, breast cancer, prostate cancer, ovarian cancer, pleural mesothelioma, urothelium carcinoma, renal cell carcinoma
- WHO performance status ≥ 2
- Able to walk independently at least 100 meters
- Estimated life expectancy of ≥ 6 month
Who cannot join
- Patients currently using nutritional supplements with branched chain amino acids
- Enteral or parenteral nutrition within 1 month
- History of ileus within 1 month
- Psychiatric disorder precluding understanding of information on trials related topics and giving informed consent
- Milk protein allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of a Specially Formulated Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program on Physical Performance in Cancer Outpatients
This study evaluates physical performance in cancer outpatients during a multimodal therapy. Half of the patients will receive physical exercise und nutrition program in combination with a specially formulated whey protein supplement, while the other half will receive standard care.
Read the detailed description
The time period of Intervention will last 3 month, measurements will be conducted at baseline and 3 month. After 6 month there will be an additional follow-up test point to assess the sustainability of the intervention. The 3-month intervention study consists of a physical exercise program and nutrition counseling in combination with a specially formulated whey protein supplement high in leucine. The standardized training program will be performed twice a week in the physical department of the Kantonsspital Winterthur (KSW) and once a week in a home based setting. Additionally, participants of the intervention group will be aks to consume 15 g of the nutrient supplement powder with approximately 150 ml water. On workout days the supplement should be taken twice a day and on the remaining days once a day. During the three month intervention study participants will take part in a nutrition counseling for at least three times.
- Conditions
- Lung Cancer, Gastro-Intestinal Cancer, Breast Cancer, Prostate Cancer, Pleural Mesothelioma, Urothelial Carcinoma
- Being tested
- physical exercise, nutrition counseling, whey protein supplement
- Keywords
- palliative
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Mesothelioma, Malignant, Carcinoma, Transitional Cell, Carcinoma, Renal Cell, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseBehavioural
The standardized Training program will be performed twice a week in the Kantonsspital Winterthur and once a week in a home based setting
nutrition counselingBehavioural
At least 3 times, participants will receive nutrition counseling to improve energy- and protein intake
whey protein supplementDietary supplement
On workout days study participants will consume twice a day 15 g of the supplement powder with approximately 150 ml water. On the remaining days participants consume the supplement once a day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks Receives: Behavioral: physical exercise; Behavioral: nutrition counseling; Dietary Supplement: whey protein supplement |
| Control group | No intervention | Participants will receive standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical performance
Physical performance will be assessed with the short physical performance battery
Measured: measured at week 0, 12 and 24
Secondary outcomes (9)
Change in body composition
Body composition will be assessed with bioimpedance
Measured: measured at week 0, 12 and 24
Change in quality of life
Quality of life will be assessed with the questerionnaire EORTC-QLQ-C30
Measured: measured at week 0, 12 and 24
Change in fatigue
Fatigue will be assessed with the questionnaire brief fatigue inventory
Measured: measured at week 0, 12 and 24
Change in physical function
Physical function will be assessed with 60s-sit-to-stand-test and timed-up\&go-test
Measured: measured at week 0, 12 and 24
Change in nutritional status
Nutritional status will be assessed with hand grip, nutritional risk screening 2002 and patient-generated subjective global assessment
Measured: measured at week 0, 12 and 24
Change in diet history
3-day food records brought in at weeks 0, 12 and 24 will be analyzed for energy- and protein intakes
Measured: measured at week 0, 12 and 24
Number of re-hospitalization
Number of re-hospitalization
Measured: up to 24 weeks
Change in WHO performance status
Change in WHO performance status
Measured: measured at week 0, 12 and 24
Overall survival
Overall survival
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startMar 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miklos Pless, Prof., Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585362
- Sponsor's protocol ID
- Leucine1.0
- Status last verified
- Jan 2019
- First submitted
- 13 Oct 2015
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Specially Formulated Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program on Physical Performance in Cancer Outpatients
- ClinicalTrials.gov ID
- NCT02585362
- Acronym / sponsor ID
- Leucine1.0
- Conditions
- Lung Cancer, Gastro-Intestinal Cancer, Breast Cancer, Prostate Cancer, Pleural Mesothelioma, Urothelial Carcinoma
- Keywords
- palliative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 23 Oct 2015 (estimated)
- 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.
This study evaluates physical performance in cancer outpatients during a multimodal therapy. Half of the patients will receive physical exercise und nutrition program in combination with a specially formulated whey protein supplement, while the other half will receive standard care.
Detailed description
The time period of Intervention will last 3 month, measurements will be conducted at baseline and 3 month. After 6 month there will be an additional follow-up test point to assess the sustainability of the intervention. The 3-month intervention study consists of a physical exercise program and nutrition counseling in combination with a specially formulated whey protein supplement high in leucine. The standardized training program will be performed twice a week in the physical department of the Kantonsspital Winterthur (KSW) and once a week in a home based setting. Additionally, participants of the intervention group will be aks to consume 15 g of the nutrient supplement powder with approximately 150 ml water. On workout days the supplement should be taken twice a day and on the remaining days once a day. During the three month intervention study participants will take part in a nutrition counseling for at least three times.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: physical exercise, Behavioral: nutrition counseling, Dietary Supplement: whey protein supplementParticipants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks |
| Control group | No intervention | –Participants will receive standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced cancer patients not eligible for curative treatment: lung cancer, gastrointestinal cancer, breast cancer, prostate cancer, ovarian cancer, pleural mesothelioma, urothelium carcinoma, renal cell carcinoma
- WHO performance status ≥ 2
- Able to walk independently at least 100 meters
- Estimated life expectancy of ≥ 6 month
Key exclusion criteria (5 listed)
- Patients currently using nutritional supplements with branched chain amino acids
- Enteral or parenteral nutrition within 1 month
- History of ileus within 1 month
- Psychiatric disorder precluding understanding of information on trials related topics and giving informed consent
- Milk protein allergy
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 |
|---|---|---|
| physical exerciseThe standardized Training program will be performed twice a week in the Kantonsspital Winterthur and once a week in a home based setting | Behavioural | Intervention group |
| nutrition counselingAt least 3 times, participants will receive nutrition counseling to improve energy- and protein intake | Behavioural | Intervention group |
| whey protein supplementOn workout days study participants will consume twice a day 15 g of the supplement powder with approximately 150 ml water. On the remaining days participants consume the supplement once a day. | Dietary supplement | Intervention group |
Primary outcome
Change in physical performance
Time frame: measured at week 0, 12 and 24
Physical performance will be assessed with the short physical performance battery
9 secondary outcomes
Change in body composition
Time frame: measured at week 0, 12 and 24
Change in quality of life
Time frame: measured at week 0, 12 and 24
Change in fatigue
Time frame: measured at week 0, 12 and 24
Change in physical function
Time frame: measured at week 0, 12 and 24
Change in nutritional status
Time frame: measured at week 0, 12 and 24
Change in diet history
Time frame: measured at week 0, 12 and 24
Number of re-hospitalization
Time frame: up to 24 weeks
Change in WHO performance status
Time frame: measured at week 0, 12 and 24
Overall survival
Time frame: up to 24 weeks
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 11 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Miklos Pless, Prof. principal investigator
Kantonsspital Winterthur KSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise, nutrition counseling and whey protein supplement in people with Lung Cancer and Gastro-Intestinal Cancer, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
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 4 inclusion and 5 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 11 Jan 2019. 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 Switzerland. 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.
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?
Change in physical performance (time frame: measured at week 0, 12 and 24). 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 11 Jan 2019.