Cancer CachexiaPhase 2NCT01505764
The Role of Ghrelin in Cancer Cachexia
A Phase 2 study testing Anamorelin HCl in people with Cancer Cachexia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Cancer is often coupled with a condition called cachexia. In this condition, individuals continue to lose weight and lean body mass, which means their muscles are getting smaller and weaker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Cachexia
- What is being tested?
- Anamorelin HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Must have incurable, histologically or cytologically documented Non-Small Cell Lung Cancer or Colo-rectal Cancer.
- Females and males at least 18 years of age.
- Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) unresectable Stage III or IV NSCLC and/or stage III or IV colorectal cancer (CRC) (not amenable to curative resection).
- Involuntary weight loss of 5% body weight over a period of 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status 2 at screening.
- Estimated life expectancy of greater than 4 months at the time of screening.
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- Presence and functional use of both hands.
- Able to understand and comply with the procedures of the handgrip strength evaluation.
- If the patient is a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 28 days following the last dose of study medication.
- Willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.
Who cannot join
- Other forms of lung cancer.
- Women who are pregnant or breast-feeding.
- Obesity.
- Recent active excessive alcohol or illicit drug use current use of marijuana or history of marijuana use over the previous 6 months.
- Severe depression.
- Other causes of cachexia such as:
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- Liver disease (AST or ALT > 3x normal levels)
- Renal failure (creatinine > 2.5 mg/dL)
- Untreated thyroid disease
- Class III-IV CHF
- AIDS
- Other cancer diagnosed within the past five years other than non-melanoma skin cancer and prostate cancer
- Severe COPD requiring use of home O2.
- Inability to increase food intake.
- Recent administration of highly emetogenic chemotherapy.
- Known HIV, active hepatitis B or C (with increased LFTs), or active tuberculosis.
- Patients who have received two prior regimens of cytotoxic chemotherapy and are undergoing, or planning to undergo, a third regimen of cytotoxic chemotherapy.
- Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to:
- Testosterone
- Androgenic compounds
- Megestrol acetate
- Methylphenidate
- Dronabinol
- Current use of steroids or history of use over the previous 6 months except as pre- and post-medications for chemotherapy administration.
- Patients unable to readily swallow oral tablets.
- An active, uncontrolled infection.
- Uncontrolled diabetes mellitus.
- Known or suspected brain metastases.
- Patients receiving strong CYP3A4 inhibitors.
- Patients receiving tube feedings or parenteral nutrition.
- Patients with any concomitant medical or psychiatric condition or social situation that would make it difficult to comply with protocol requirements, including the inability to comply with handgrip strength determinations in both hands; for example, pre-existing neurological impairment.
- Previous exposure to Anamorelin HCl.
- Patients actively receiving a concurrent investigational agent, or any patients that have received an investigational agent within four weeks prior to randomization.
- Current use of diuretics or history of intermittent diuretic usage for any reason over the previous 3 months.
- History of claustrophobia.
- Cachexia deemed by the investigator to be solely due to chemo or radiation treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
Cancer is often coupled with a condition called cachexia. In this condition, individuals continue to lose weight and lean body mass, which means their muscles are getting smaller and weaker. Studies have shown that cancer patients who are losing weight often are responding poorly to chemotherapy, are at greater risk of infection and have a reduced life expectancy. Also, people may not want to eat. To date, there are no approved treatments available for this condition.
This study is going to study the benefits of the use of the study drug, Anamorelin hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer. Studies done before with the study drug have shown that the drug can help the cachectic condition. The purpose of this research study is to evaluate the effectiveness of Anamorelin HCl compared to placebo on body composition (amount of cell mass, fat, muscle, etc.) including measurements of body potassium and nitrogen stores.
In addition to the above, the study will also assess the effect of the study drug on handgrip strength, body weight, lean muscle mass, quality of life, appetite \& food intake, certain blood markers, energy expenditure (the amount of energy participants burn), functional performance, safety and tolerability of Anamorelin HCl.
Read the detailed description
Subjects enrolled in the study will be randomly chosen to receive either Anamorelin HCL at a dose of 100 mg per day for 12 weeks or matching placebo. The chances of receiving anamorelin or placebo are 1 in 2. Which subject receives anamorelin or placebo will be decided at random. Neither the subject nor the study doctor will know which study drug the subject is receiving. The subject will be asked to visit the clinic at Day 1, Day 28, Day 56 and Day 84. There will also be a Day 112 follow-up visit and the medical records will be checked after that to see how the subjects are doing.
- Conditions
- Cancer Cachexia
- Being tested
- Anamorelin HCl, Placebo
- Keywords
- Cachexia
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anamorelin HClDrug
100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
PlaceboDrug
Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Anamorelin HCl) | Experimental | Anamorelin HCl Receives: Drug: Anamorelin HCl |
| Arm 2 (Placebo) | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Body Potassium.
percentage change from baseline
Measured: day 84
Secondary outcomes (11)
Lean Mass Measured by Densitometry.
lean body mass measured by DEXA. Percentage of change day 84-baseline.
Measured: day 84
Muscle Strength as Measured by Grip Strength.
Dominant hand grip strength day 84 - percent change from baseline
Measured: day 84
Body Weight.
percent change from day 84-baseline
Measured: day 84
Quality of Life.
Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments - percentage of change day 84-baseline
Measured: day 84
Appetite.
Appetite measured by a visual analogue scale ASAS. Percentage of change day84-baseline
Measured: day 84
Resting Energy Expenditure.
% change between day 84 and baseline
Measured: day 84
Functional Performance.
Functional performance using stair-climbing power day 84 percent change from baseline
Measured: day 84
Body Composition.
Body composition as measured by Total body nitrogen. Percentage of change day 84-baseline
Measured: day 84
Stair Climbing Power
Percent change from baseline
Measured: day 84
1-repetition Max. Strength
leg extension - percentage of change day 84 to baseline
Measured: day 84
Food Diary Calorie Count
change between day 84 and baseline
Measured: day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2016
- Study completionMar 2016
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer CachexiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Helsinn Therapeutics (U.S.), Inc
- Responsible party
- Sponsor
- Investigators
- Jose M. Garcia, MD PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505764
- Sponsor's protocol ID
- CLIN-013-08F
- Other IDs
- HT-ANAM-208
- Status last verified
- Jun 2018
- First submitted
- 7 Dec 2011
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ghrelin in Cancer Cachexia
- ClinicalTrials.gov ID
- NCT01505764
- Acronym / sponsor ID
- CLIN-013-08F
- Conditions
- Cancer Cachexia
- Keywords
- Cachexia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Helsinn Therapeutics (U.S.), Inc
- Study start
- Jun 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Jan 2012 (estimated)
- Results
- Posted 24 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer is often coupled with a condition called cachexia. In this condition, individuals continue to lose weight and lean body mass, which means their muscles are getting smaller and weaker. Studies have shown that cancer patients who are losing weight often are responding poorly to chemotherapy, are at greater risk of infection and have a reduced life expectancy. Also, people may not want to eat. To date, there are no approved treatments available for this condition.
This study is going to study the benefits of the use of the study drug, Anamorelin hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer. Studies done before with the study drug have shown that the drug can help the cachectic condition. The purpose of this research study is to evaluate the effectiveness of Anamorelin HCl compared to placebo on body composition (amount of cell mass, fat, muscle, etc.) including measurements of body potassium and nitrogen stores.
In addition to the above, the study will also assess the effect of the study drug on handgrip strength, body weight, lean muscle mass, quality of life, appetite \& food intake, certain blood markers, energy expenditure (the amount of energy participants burn), functional performance, safety and tolerability of Anamorelin HCl.
Detailed description
Subjects enrolled in the study will be randomly chosen to receive either Anamorelin HCL at a dose of 100 mg per day for 12 weeks or matching placebo. The chances of receiving anamorelin or placebo are 1 in 2. Which subject receives anamorelin or placebo will be decided at random. Neither the subject nor the study doctor will know which study drug the subject is receiving. The subject will be asked to visit the clinic at Day 1, Day 28, Day 56 and Day 84. There will also be a Day 112 follow-up visit and the medical records will be checked after that to see how the subjects are doing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Anamorelin HCl) | Experimental | Drug: Anamorelin HClAnamorelin HCl |
| Arm 2 (Placebo) | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must have incurable, histologically or cytologically documented Non-Small Cell Lung Cancer or Colo-rectal Cancer.
- Females and males at least 18 years of age.
- Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) unresectable Stage III or IV NSCLC and/or stage III or IV colorectal cancer (CRC) (not amenable to curative resection).
- Involuntary weight loss of 5% body weight over a period of 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status 2 at screening.
Key exclusion criteria (36 listed)
- Other forms of lung cancer.
- Women who are pregnant or breast-feeding.
- Obesity.
- Recent active excessive alcohol or illicit drug use current use of marijuana or history of marijuana use over the previous 6 months.
- Severe depression.
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 |
|---|---|---|
| Anamorelin HCl100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day. | Drug | Arm 1 (Anamorelin HCl) |
| PlaceboPlacebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day. | Drug | Arm 2 (Placebo) |
Primary outcome
Total Body Potassium.
Time frame: day 84
percentage change from baseline
11 secondary outcomes
Lean Mass Measured by Densitometry.
Time frame: day 84
Muscle Strength as Measured by Grip Strength.
Time frame: day 84
Body Weight.
Time frame: day 84
Quality of Life.
Time frame: day 84
Appetite.
Time frame: day 84
Resting Energy Expenditure.
Time frame: day 84
Functional Performance.
Time frame: day 84
Body Composition.
Time frame: day 84
Stair Climbing Power
Time frame: day 84
1-repetition Max. Strength
Time frame: day 84
Food Diary Calorie Count
Time frame: day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cancer Cachexia
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
RecruitingPhase 2/3
Visugromab in Cachexia International Trial
Cancer-associated Cachexia
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
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.
Jose M. Garcia, MD PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anamorelin HCl in people with Cancer Cachexia, run by VA Office of Research and Development 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 10 inclusion and 36 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 17 Jul 2018. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Body Potassium. (time frame: day 84). 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 17 Jul 2018.