Metastatic CancersPhase 2/3NCT06085716
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
A Phase 2/3 study testing Psychoeducational Intervention in people with Metastatic Cancers and Fatigue, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancers, Fatigue
- What is being tested?
- Psychoeducational Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2024to 31 Aug 2029
- Phase
- Phase 2/3
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 advanced cancer patients or s or have a history of advanced cancer, having fatigue with severity of ≥ 4/10, on a 0-10 scale (Edmonton Symptom Assessment Scale), and presence of fatigue for at least 2 weeks.
- Have no clinical evidence of cognitive failure as evidenced by treating clinician assessment at screening (Memorial Delirium Assessment Scale of less than 13/30).
- Be aged 18 years or older.
- Be willing to complete in-person or telemedicine follow-up visits with research staff, and able to complete Psychoeducational intervention either in person or virtually within Texas.
- Have a hemoglobin level of ≥8 g/dL within 1 month (+/- 2 weeks) of enrollment.
- Be able to understand the description of the study and sign a written informed consent.
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- Have a ECOG performance status score of 0 to 2; and
- Be seen at an outpatient clinic at MD Anderson Cancer Center's (MDA) main campus or its Houston Area Locations (HALs)
- Able to read, write and speak English
Who cannot join
- Have a major contraindication to placebo (e.g., allergy or hypersensitivity to study medications or their constituents), or conditions making adherence difficult as determined by the attending physician.
- Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.
- Be pregnant (as documented in chart) or become pregnant while on study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Centerr
Houston, Texas, 77030
Sriram Yennu, MD, 713-792-3938, syennu@mdanderson.org
Sriram Yennu, MD
About this study
To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone.
Read the detailed description
Primary Objectives:
- To determine if the combination therapy of PI with OLP (combination therapy group) is superior to PI alone group in the treatment of cancer-related fatigue (CRF) as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale.
We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF compared to PI alone.
Secondary Objectives:
- To determine if Combination Therapy group is superior to PI Only group for the treatment of CRF at 3 months and 6 months after treatment. We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF after 3 months and 6 months after treatment
- To determine the effects of combination therapy on fatigue-related quality-of-life, mood, sleep-wake activity, cognitive measures, and inflammation. We will assess measures including quality of life (Functional Assessment of Cancer Therapy - General, FACT- G), multidimensional fatigue (Multidimensional Fatigue Symptom Inventory, MFSI-SF), sleep disturbance (PROMIS-sleep), anxiety (Hospital Anxiety and Depression Scale - HADS), depressed mood (HADS), cognitive function (Symbol digit modality test, SDMT), sleep/wake time activity (actigraphy), and inflammation (C-reactive protein levels).
We hypothesize that combination therapy will result in improvements in CRF-related quality of life, mood, sleep-wake activity, and cognitive measures.
- Conditions
- Metastatic Cancers, Fatigue
- Being tested
- Psychoeducational Intervention, Open Label Placebo, Psychoeducational Intervention+Placebo
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational InterventionBehavioural
Participants in the PI group will complete the educational sessions only.
Open Label PlaceboDrug
This group will only take placebo capsules every day.
Psychoeducational Intervention+PlaceboBehavioural
This group will take the placebo capsules every day, as well as completing the educational sessions.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational Intervention | Experimental | Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned: Receives: Behavioral: Psychoeducational Intervention |
| Open Label Placebo | Experimental | Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned: Receives: Drug: Open Label Placebo |
| Psychoeducational Intervention+Placebo | Experimental | Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned: Receives: Behavioral: Psychoeducational Intervention+Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start16 Feb 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sriram Yennu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085716
- Sponsor's protocol ID
- 2023-0466
- Other IDs
- NCI-2023-08682
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No