Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Infertility

Breast Diseases

Skin Diseases

Genital Diseases

Urogenital Diseases

psychosocial assessment and care

Zora Neskovic-Konstantinovic

RATIONALE: Adjuvant therapy given after surgery for early breast cancer may cause infertility. Assessing young women's attitudes and feelings about the risk of infertility may help improve the ability to plan effective treatment.

PURPOSE: This clinical trial is studying young women's attitudes and feelings about the risk of infertility related to adjuvant therapy for stage I or stage II breast cancer.

OBJECTIVES:

* Determine the attitude toward the risk of infertility related to adjuvant therapy in women with early breast cancer.
* Correlate, if possible, the patient's attitude with the fact that the patient already has children or the time interval between the date of breast cancer diagnosis and the date of study participation.

OUTLINE: This is a multicenter study.

Patients complete a questionnaire administered by a nontreating physician.

PROJECTED ACCRUAL: A total of 385 patients will be accrued for this study.

Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer

A Survey of the Breast International Group (B.I.G.) to Assess the Attitude of Patients Aged Less Than 35 Years, With Early Breast Cancer, Toward the Risk of Loss of Fertility Related to Adjuvant Therapies

German Adjuvant Breast Cancer Group

ETOP IBCSG Partners Foundation

European Organisation for Research and Treatment of Cancer - EORTC

Behaviors and Mental Disorders

Prostatic Neoplasms

Erectile Dysfunction

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Quality of Life

Anticoagulants

All Drugs and Chemicals

Vasodilator Agents

Urological Agents

Other Dietary Supplements

Citric Acid

Sodium Citrate

Sildenafil Citrate

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Citrate

Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.

Placebo with similar "dose escalation" opportunity for 12 weeks.

sildenafil citrate

Placebo

Deborah Watkins Bruner, RN, PhD

RATIONALE: Sildenafil may be effective in helping patients who have undergone treatment for prostate cancer to have an erection for sexual activity and may improve sexual satisfaction and quality of life.

PURPOSE: Randomized clinical trial to study the effectiveness of sildenafil in treating erectile dysfunction in patients who have undergone radiation therapy and hormone therapy for prostate cancer in clinical trial RTOG-9910.

OBJECTIVES:

* Compare the effect of sildenafil vs placebo on erectile dysfunction in patients with prostate cancer treated with radiotherapy and antiandrogens on RTOG-9910.
* Compare the overall sexual function and satisfaction of patients treated with these regimens.
* Compare sexual satisfaction of partners of patients treated with these regimens.
* Compare patient and partner marital adjustment after treatment with these regimens.
* Determine factors that may predict response to sildenafil, including age, pretreatment sexual function, tobacco use, and comorbidities in these patients.

OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to prior use of sildenafil after treatment on RTOG-9910 and level of response (No vs yes \[unsatisfactory\] vs yes \[satisfactory\]), International Index of Erectile Function (IIEF) Question #1 score (0-1 vs 2-3), and RTOG-9910 treatment arm (I vs II). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral sildenafil 1 hour prior to desired sexual intercourse.
* Arm II: Patients receive oral placebo 1 hour prior to desired sexual intercourse.

Treatment on both arms continues for 12 weeks. Patients then cross over to treatment on the other arm for 12 weeks.

Quality of life, including sexual function, marital adjustment, and partner's satisfaction, is assessed at baseline, at 12 and 25 weeks, and at 1 year.

Patients are followed at 1 year.

PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study.

Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Symptoms and General Pathology

Recurrence

Pilocarpine

Muscarinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Patients receive oral pilocarpine hydrochloride once a day for 3 days, twice a day for 3 days, three times a day for 3 days, and then 4 times a day for up to 6 weeks in the absence of unacceptable toxicity.

Patients receive oral pilocarpine hydrochloride once a day for 3 days and then twice a day for up to 6 weeks in the absence of unacceptable toxicity.

Patients receive oral placebo once a day for 3 days, twice a day for 3 days, three times a day for 3 days, and then 4 times a day for up to 6 weeks in the absence of unacceptable toxicity.

Patients receive oral placebo once a day for 3 days and then twice a day for up to 6 weeks in the absence of unacceptable toxicity.

pilocarpine hydrochloride

placebo

Charles L. Loprinzi, MD

RATIONALE: Pilocarpine may decrease vaginal dryness and improve quality of life in patients with breast cancer It is not yet known whether pilocarpine is more effective than a placebo in treating vaginal dryness in patients with breast cancer.

PURPOSE: This randomized phase III trial is studying pilocarpine to see how well it works compared to a placebo in treating vaginal dryness in patients with breast cancer.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (18 to 45 vs 46 to 55 vs 56 to 65 vs \> 65), concurrent tamoxifen therapy (yes vs no vs unknown \[e.g., on a blinded clinical study\]), concurrent aromatase inhibitor therapy (yes vs no vs unknown \[e.g., on a blinded clinical study\]), and perception of severity of vaginal symptoms at baseline (mild vs moderate vs severe). Patients are randomized to 1 of 4 treatment arms. The primary and secondary objectives of the study are described below.

OBJECTIVES:

Primary

* Determine the effectiveness of pilocarpine hydrochloride for alleviation of vaginal dryness in patients with breast cancer.

Secondary

* Evaluate any toxicities arising from pilocarpine hydrochloride in these patients.
* Evaluate quality of life of these patients treated with pilocarpine hydrochloride.

Quality of life was assessed at baseline and then weekly for 6 weeks.

Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double Blind, Placebo-Controlled Study

Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values \* 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.

CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.

The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values \* 6) / 3) / 6). The average pro-rated AUC scores was compared in each of the Pilocarpine arms against the collective placebo arm.

The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The change from baseline scores was calculated by subtracting the baseline item scores from the scores at 6 week.

Alliance for Clinical Trials in Oncology

Adverse event information at end of 6 weeks is not available on one participant from collective placebo arm.

Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.

Pilocarpine 2 Times Per Day

Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.

Pilocarpine 4 Times Per Day

Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.

Collective Placebo

Total

Age, Continuous

Female

Sex/Gender, Customized

Race (NIH/OMB)

United States

Region of Enrollment

Unknown

Tamoxifen use

Current aromatase inhibitor

Mild

Moderate

Severe

Severity of vaginal symptoms

Breast cancer history

Dr. Charles L. Loprinzi

Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).

Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics

Comparison of Urinary Frequency among arms

Grade 1 or 2 rigors

Grade 1 or 2 urinary frequency

Grade 1 or 2 nausea

Grade 1 or 2 sweating

Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0

Interfered with general activity

Interfered with mood

Interfered with normal work

Interfered with relations with other people

Interfered with sleep

Interfered with enjoyment of life

Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living

Includes all participants who completed both baseline and week 6 assessments.

Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores

Overall Study

Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6 weeks comprising the following four 90-minute sessions: the Story of Cancer; Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping, Support, and Adaptation. Patients and their partners complete treatment satisfaction questionnaires after completion of study intervention.

Patients and their partners receive standard psychosocial care. All participants complete questionnaires assessing psychological distress, intimacy, communication patterns, and overall relationship adjustment/satisfaction at baseline and at 1 month after completion of study intervention

counseling intervention

questionnaire administration

Talia Zaider, PhD

RATIONALE: A couples therapy program may enhance intimacy and reduce psychological distress in patients with prostate cancer and in their partners.

PURPOSE: This randomized clinical trial is studying how well couples therapy enhances intimacy and reduces psychological distress in patients with advanced or recurrent prostate cancer and in their partners.

OBJECTIVES:

* Determine the feasibility of Intimacy-Enhancing Couples Therapy (IECT) for patients with advanced or recurrent prostate cancer and their partners.
* Compare the effect of IECT vs usual care on patients' and their partners' level of global psychological distress.
* Compare the effect of IECT vs usual care on relationship intimacy in these participants.

OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are stratified according to marital distress based on partners' scores on the Abbreviated Dyadic Adjustment Scale (high \[\< 21\] vs low \[≥ 21\]). Patients and their partners are randomized to 1 of 2 arms.

* Arm I: Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6 weeks comprising the following four 90-minute sessions: the Story of Cancer; Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping, Support, and Adaptation. Patients and their partners complete treatment satisfaction questionnaires after completion of study intervention.
* Arm II: Patients and their partners receive standard psychosocial care. All participants complete questionnaires assessing psychological distress, intimacy, communication patterns, and overall relationship adjustment/satisfaction at baseline and at 1 month after completion of study intervention.

Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners

A Pilot Study of an Intimacy-Enhancing Couples Therapy for Men With Advanced Prostate Cancer and Their Partners

Fox Chase Cancer Center

Memorial Sloan Kettering Cancer Center

Adenocarcinoma

Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.

Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.

radiation therapy

Eric Horwitz, MD

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) may reduce damage to healthy tissue near the tumor. It is not yet known whether reducing the dose of radiation to erectile tissue will help prevent erectile dysfunction.

PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy alone to see how well it works compared to intensity-modulated radiation therapy with reduced doses to erectile tissue in treating patients with stage II prostate cancer.

OBJECTIVES:

Primary

* Compare erectile dysfunction in patients with stage T1b-T2c adenocarcinoma of the prostate after treatment with intensity-modulated radiotherapy with vs without dose sparing for erectile tissue.

Secondary

* Compare biochemical freedom from failure rates, as a measure of prostate cancer control, in patients treated with these regimens.
* Compare the quality of life of patients treated with these regimens.
* Determine the association of molecular markers and biochemical freedom from failure rate and other endpoints in patients treated with these regimens.

OUTLINE: This is a randomized, single-blind study. Patients are stratified according to age (≤ 65 vs \> 65), prescription radiotherapy dose (74 Gy vs 76 Gy), and frequency of erection during sexual activity within the past 4 weeks (a few times vs sometimes vs most times to always). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
* Arm II: Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.

Treatment in both arms continues in the absence of unacceptable toxicity or disease metastasis.

Quality of life is assessed at baseline, at 6 and 12 months, and then annually for 4 years

Patients are followed at 3 months and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 2.5 years.

Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer

Outcomes Following Intensity Modulated Radiation Therapy With And Without Erectile Tissue Dose Sparing For Favorable To Intermediate Risk Prostate Cancer

Postage Stamp Test

-A row of stamps is placed around the base of the penis and the ends are moistened and joined. If the circle is broken in the morning then the subject was recorded as having had a nocturnal erection

International Index of Erectile Function (IIEF) Questionnaire

* 15-item questionnaire that measures erectile function
* Includes companion questionnaire which measures how the partner feels her sexual relationship with the patient has changed since his cancer diagnosis and therapy

Patients without documented failure will undergo needle biopsy of the prostate. A minimum of 12 core biopsies will be taken and additional biopsies will be taken from any suspicious areas (ultrasound or palpation) and/or the original site of biopsy confirmation of prostate cancer at diagnosis. The 12 biopsy sites include sextant, bilateral lateral base, bilateral lateral mid-gland and bilateral transition zone. These data will enable us to evaluate the extent of disease eradication, as well as the prognostic significance of positive biopsies in otherwise palpably normal prostate glands after treatment.

Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.

radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.

s-IMRT

Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.

radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.

ETS-IMRT

Sex: Female, Male

White

Black

Hispanic

Race/Ethnicity, Customized

The magnitude of the effect of erectile sparing constraints may be decreased for patients who experience dose-limiting parameters in the s-IMRT arm.

Some patients did not complete follow-up, and to submit follow-up questionnaires at 24 months post-treatment.

Eric Horwitz

Some patients did not submit follow-up questionnaires at 24 months post-treatment

Erectile Dysfunction Rates

Percentage of Patients With Freedom From Biochemical Failure

Acute GI Toxicity

Acute GU Toxicity

Standard IMRT (S-IMRT)

Erectile Tissue Sparing IMRT (ETS-IMRT)

Amino Acids

Arginine

Patients receive oral placebo 3 pills twice daily

ArginMax

Kathryn M. Greven, MD

RATIONALE: L-arginine supplements may improve the quality of life and sexual function in women who are cancer survivors.

PURPOSE: This randomized clinical trial is studying an L-arginine supplement to see how well it works compared with a placebo in treating women who are cancer survivors.

OBJECTIVES:

Primary

* Determine whether an L-arginine-based nutritional supplement (ArginMax®) improves the quality of life and sexual function in female cancer survivors.

Secondary

* Compare quality of life of patients treated with ArginMax® vs placebo.
* Compare toxicity of these regimens in these patients.
* Describe the sexual function symptom clusters (if any) in these patients.

OUTLINE: This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2 or 3), type of malignancy (pelvic vs nonpelvic), and ovarian functional status (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive an oral L-arginine-based nutritional supplement (ArginMax®) twice daily.
* Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity.

Sexual function, quality of life, and toxicity are assessed at baseline and every 4 weeks for 12 weeks.

PROJECTED ACCRUAL: A total of 186 patients will be accrued for this study.

L-Arginine Supplements in Treating Women Who Are Cancer Survivors

A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors

Patients filled out the Female Sexual Function Index (FSFI) at baseline and at 4, 8, and 12 weeks following randomization. The FSFI is comprised of 2 questions related to desire, 4 questions related to arousal, 4 questions related to lubrication, 3 questions related to orgasm, 3 questions related to satisfaction, and 3 questions related to pain. Subscale scores range from 1.2 to 6 (desire) or 0 to 6 (arousal, lubrication, orgasm, and pain) or 0.8 to 6 (satisfaction). A total FSFI score is computed as the sum of the individual subscales; the overall score ranges from 2 to 36. Higher scores indicate better sexual function. The primary outcome comparison is at 12 weeks.

Patients filled out the FACT-G quality of life questionnaire at baseline and at 4, 8, and 12 weeks following randomization. The FACT-G questionnaire is comprised of 7 questions related to physical well-being, 7 questions related to social well-being, 6 questions related to emotional well-being, and 7 questions related to functional well-being. Subscale scores range from 0 to 24 (Emotional) or 0 to 28 (Functional, Social, and Physical). A total FACT-G score is computed as the sum of the individual subscales; the overall score ranges from 0 to 108. Higher scores indicate better quality of life. The primary comparison was at 12 weeks.

Wake Forest University Health Sciences

The sample size for this section is the number of participants who had post-randomization toxicity data.

ArginMax® 3 pills twice daily

ArginMax: Given orally

Arm I: ArginMax

Patients receive oral placebo 3 pills twice daily

Placebo: Given orally

Arm II: Placebo

Age, Categorical

Ethnicity (NIH/OMB)

Dr. Doug Case

The null hypothesis is that sexual function will be the same in both groups at 12 weeks. A Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.

Participants who filled out the FSFI at any time

Sexual Function

The null hypothesis was that quality of life would be the same in both groups at 12 weeks. A mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.

Participants who filled out the FACT-G at any time

Uterine Cervical Neoplasms

Carcinoma

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

management of therapy complications

RATIONALE: Vaginal changes that may effect sexual function occur in patients undergoing treatment for cervical cancer.

PURPOSE: Clinical trial to determine the type of vaginal changes such as vaginal dryness that occur in patients receiving treatment for cervical cancer and the effect these changes have on sexual function.

OBJECTIVES:

* Obtain estimates of changes in vaginal length, perceived vaginal elasticity, perceived vaginal lubrication, and sexual activity, response, and satisfaction among patients with stage IB2 cervical cancer.
* Compare these differences between the patients in the two treatment groups in GOG-0201.
* Determine the relationships between vaginal dilation activities and vaginal length changes in these patients.
* Determine the association between smoking and vaginal length and between smoking and vaginal dryness in these patients after therapy for cervical cancer.
* Assess the extent of subject interest in and preferred methods of sexual counseling related to problems resulting from treatment in these patients.

OUTLINE: Vaginal length is measured using Vaginal Sound, a modified plastic vaginal dilator. The data about vaginal elasticity and lubrication and sexual activity, response, and satisfaction are obtained from patient self-report, as well as vaginal dilation activities. Measurement and assessments are taken before treatment and then at 3, 6, 12, and 24 months.

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: Approximately 150 patients will be accrued for this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer	NCT00062400	Breast Cancer Psychosocial Ef... Sexual Dysfunct... Sexuality and R...	psychosocial as...	- 35 Years	European Organisation for Research and Treatment of Cancer - EORTC
Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer	NCT00057759	Prostate Cancer Psychosocial Ef... Radiation Toxic... Sexual Dysfunct... Sexuality and R...	sildenafil citr... Placebo	18 Years -	Radiation Therapy Oncology Group
Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer	NCT00343382	Breast Cancer Vaginal Dryness	pilocarpine hyd... placebo	18 Years -	Alliance for Clinical Trials in Oncology
Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer	NCT00057759	Prostate Cancer Psychosocial Ef... Radiation Toxic... Sexual Dysfunct... Sexuality and R...	sildenafil citr... Placebo	18 Years -	Radiation Therapy Oncology Group
Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners	NCT00483678	Prostate Cancer Psychosocial Ef... Sexual Dysfunct... Sexuality and R...	counseling inte... questionnaire a... psychosocial as...	18 Years - 120 Years	Memorial Sloan Kettering Cancer Center
Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer	NCT00084552	Prostate Cancer Sexual Dysfunct... Sexuality and R...	radiation thera...	18 Years -	Fox Chase Cancer Center
L-Arginine Supplements in Treating Women Who Are Cancer Survivors	NCT00459134	Sexual Dysfunct... Sexuality and R... Unspecified Adu...	ArginMax Placebo	18 Years -	Wake Forest University Health Sciences
Vaginal Changes and Sexual Function in Patients With Cervical Cancer	NCT00053261	Cervical Cancer Sexuality and R...	management of t...	- 69 Years	GOG Foundation

Spots Global Cancer Trial Database for sexuality and reproductive issues