NCT01231932

Characterizing Fatigue Experienced by Cancer Patients Receiving Primary Treatment and Cancer Survivors

Terminated Last updated 19 June 2025

What this trial tests

trial in Cancer in 163 participants. Terminated before completion.

Timeline

4 February 2011

Primary endpoint
1 November 2024

16 April 2025

Quick facts

Lead sponsor	National Institute of Nursing Research (NINR)
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	163
Start date	4 February 2011
Primary completion	1 November 2024
Estimated completion	16 April 2025
Sites	1 location across United States

Conditions studied

• Cancer — all drugs for Cancer →
• Fatigue — all drugs for Fatigue →
• Prostate Cancer — all drugs for Prostate Cancer →
• Breast Cancer — all drugs for Breast Cancer →

Sponsor

National Institute of Nursing Research (NINR)

Who can join

Adults 18 to 120, any sex, with Cancer or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Fatigue is a common side effect of cancer and its treatment. Up to 96% of patients with cancer have fatigue. The cause of fatigue in people with cancer or those receiving treatment is poorly understood, making fatigue hard to treat. More research is necessary to understand why cancer patients experience fatigue. Previous research has shown that fatigue may be caused by a number of factors, including problems with the immune system response of the body while undergoing cancer treatment. The researchers of this study are trying to understand how the immune system and other chemicals of the body change while a person receives cancer treatment and how these changes play a role in causing fatigue. The researchers are also interested in how a person s quality of life is affected by fatigue.

Objectives:

\- To study fatigue in individuals who have cancer, are receiving cancer treatment, or have completed cancer treatment.

Eligibility:

* Individuals at least 18 years of age.
* Receiving cancer treatment, OR completed primary treatment for cancer (e.g., cancer survivors), OR on active surveillance for localized cancer.

Design:

* This study involves an initial screening visit and up to three outpatient visits.
* Participants will be screened with a medical history review (can be done virtually) and blood tests. A physical exam might also occur.
* Participants undergoing cancer treatment that has a clear completion date, will have the following visits:

* Before the start of treatment.
* At the end of treatment.
* At least 3 months after treatment ends.
* Participants not receiving treatment, are cancer survivors, or undergoing cancer treatment that does not have a clear completion date, will have up to 3 visits:

* Before the start of treatment or whenever you begin the study.
* At least 3 months after your first visit.
* At least 3 months after your second visit.
* At each study visit, participants will complete the following tasks (some of the tasks can be done from home or virtually):

* Questionnaires about physical activity, fatigue, depression, and quality of life (can be done at home or virtually).
* Have blood drawn.
* Physical activity device and journals to study how fatigue affects physical activity.
* Optional tests:

* Computer games testing your memory, attention, and ability to follow directions.
* Hand grip strength test to evaluate physical strength.
* Treatment will not be provided under this study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Brain-derived neurotrophic factor polymorphism Val66Met protects against cancer-related fatigue.
   Feng LR, Juneau P, Regan JM, Liwang J, et al · · 2020 · cited 12× · PMID 32848137 · DOI 10.1038/s41398-020-00990-4