Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

NCT ID: NCT06085716

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-16
• Study Completion Date: 2029-08-31

Brief 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.

Detailed Description

Primary Objectives:

1. 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:

1. 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

3. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Psychoeducational Intervention

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:

Group Type: EXPERIMENTAL

Psychoeducational Intervention

Intervention Type: BEHAVIORAL

Participants in the PI group will complete the educational sessions only.

Open Label Placebo

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:

Group Type: EXPERIMENTAL

Open Label Placebo

Intervention Type: DRUG

This group will only take placebo capsules every day.

Psychoeducational Intervention+Placebo

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:

Group Type: EXPERIMENTAL

Psychoeducational Intervention+Placebo

Intervention Type: BEHAVIORAL

This group will take the placebo capsules every day, as well as completing the educational sessions.

Interventions

Psychoeducational Intervention

Participants in the PI group will complete the educational sessions only.

Intervention Type: BEHAVIORAL

Open Label Placebo

This group will only take placebo capsules every day.

Intervention Type: DRUG

Psychoeducational Intervention+Placebo

This group will take the placebo capsules every day, as well as completing the educational sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Be advanced cancer patients (incurable metastatic), having fatigue with severity of 4/10, on a 0-10 scale (Edmonton Symptom Assessment Scale) for at least 2 weeks.

2. Have no clinical evidence of cognitive failure as evidenced by treating clinician assessment at screening (Memorial Delirium Assessment Scale of less than 13/30).

3. Be aged 18 years or older.

4. Be willing to complete in-person or with research staff, and able to complete Psychoeducational intervention either in person or virtually within Texas.

5. Have a hemoglobin level of ≥10 g/dL within 2 weeks of enrollment.

6. Be able to understand the description of the study and sign a written informed consent.

7. Have a ECOG performance status score of 0 to 2; and

8. Be seen at an outpatient clinic at MD Anderson Cancer Center's (MDA) main campus or its Houston Area Locations (HALs)

Exclusion Criteria

1. 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.

2. Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.

3. Be pregnant or become pregnant while on study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sriram Yennu, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

MD Anderson Cancer Centerr

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sriram Yennu, MD

Role: CONTACT

syennu@mdanderson.org

(713) 792-3938

Facility Contacts

Sriram Yennu, MD

Role: primary

syennu@mdanderson.org

713-792-3938

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2023-08682

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0466

Identifier Type: -

Identifier Source: org_study_id